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Study to Assess Safety and Efficacy of the Second Mitochondrial-derived Activator of Caspases (SMAC) Mimetic Debio 1143 (SMARTPLUS-106)

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ClinicalTrials.gov Identifier: NCT04122625
Recruitment Status : Completed
First Posted : October 10, 2019
Results First Posted : June 12, 2023
Last Update Posted : June 12, 2023
Sponsor:
Information provided by (Responsible Party):
Debiopharm International SA

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Solid Tumor
Interventions Drug: Debio 1143
Drug: Nivolumab
Enrollment 46
Recruitment Details Participants took part at 24 investigational sites in the United States, Spain, and France from 26 April 2019 to 6 April 2022.
Pre-assignment Details A total of 46 participants were enrolled in this study, 11 participants with advanced solid malignancies who failed prior systemic standard treatments into Part A and 35 participants into Part B of the study. Part B of the study was started after recommended phase 2 dose (RP2D) was determined in Part A and did not include any participants from Part A.
Arm/Group Title Part A - Debio 1143 150 mg + Nivolumab Part A - Debio 1143 200 mg + Nivolumab Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab
Hide Arm/Group Description Participants received Debio 1143, 150 milligrams (mg) capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, intravenous (IV) infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles. Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles. Participants with small-cell lung cancer (SCLC) received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles. Participants with squamous cell carcinoma of the head and neck (SCCHN) received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles. Participants with gastrointestinal (GI) cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles. Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Period Title: Part A (up to 2.92 Years)
Started 3 8 0 0 0 0
Completed [1] 1 4 0 0 0 0
Not Completed 2 4 0 0 0 0
Reason Not Completed
Death             2             4             0             0             0             0
[1]
Completed also includes 1 participant in arm group, Part A: Debio 1143 200 mg + Nivolumab who entered and completed the extension phase of Part A.
Period Title: Part B (up to 2.33 Years)
Started 0 0 8 8 8 11
Completed 0 0 2 0 0 4
Not Completed 0 0 6 8 8 7
Reason Not Completed
Patient lost to follow-up             0             0             1             1             2             0
Death             0             0             5             7             6             7
Arm/Group Title Part A - Debio 1143 150 mg + Nivolumab Part A - Debio 1143 200 mg + Nivolumab Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab Total
Hide Arm/Group Description Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles. Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles. Participants with SCLC received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles. Participants with SCCHN received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles. Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles. Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles. Total of all reporting groups
Overall Number of Baseline Participants 3 8 8 8 8 11 46
Hide Baseline Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 8 participants 8 participants 8 participants 8 participants 11 participants 46 participants
71.0
(58 to 79)
55.5
(27 to 81)
65.5
(57 to 74)
61.6
(48 to 71)
63.9
(36 to 81)
64.8
(43 to 79)
63.0
(27 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 8 participants 8 participants 8 participants 8 participants 11 participants 46 participants
Female
1
  33.3%
1
  12.5%
4
  50.0%
1
  12.5%
3
  37.5%
11
 100.0%
21
  45.7%
Male
2
  66.7%
7
  87.5%
4
  50.0%
7
  87.5%
5
  62.5%
0
   0.0%
25
  54.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 8 participants 8 participants 8 participants 8 participants 11 participants 46 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.2%
Not Hispanic or Latino
3
 100.0%
7
  87.5%
5
  62.5%
6
  75.0%
7
  87.5%
6
  54.5%
34
  73.9%
Unknown or Not Reported
0
   0.0%
1
  12.5%
2
  25.0%
2
  25.0%
1
  12.5%
5
  45.5%
11
  23.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 3 participants 8 participants 8 participants 8 participants 8 participants 11 participants 46 participants
White
3
 100.0%
7
  87.5%
6
  75.0%
5
  62.5%
7
  87.5%
6
  54.5%
34
  73.9%
Other
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
1
   2.2%
Unknown
0
   0.0%
1
  12.5%
2
  25.0%
2
  25.0%
1
  12.5%
5
  45.5%
11
  23.9%
1.Primary Outcome
Title Part A: Number of Participants With Dose-limiting Toxicities (DLTs)
Hide Description DLT: any of following treatment-emergent adverse events (TEAEs) as per NCI CTCAE Grade V5.0 Criteria (Grades 1=mild, 2=moderate, 3=severe and 4 or 5= life-threatening/fatal outcomes) which are possibly, probably or definitely related to combination treatment and occurring in Cycle 1 (1 Cycle=28 days): Any Grade 4 or 5 hematologic toxicity, clinical or laboratory non-hematologic toxicity; febrile neutropenia any grade, Grade 3 thrombocytopenia if associated with bleeding or requiring platelet transfusion; Grade 2; Grade 3 and any other Grade 3 non-hematologic, treatment-related clinical toxicity lasting ≥3 days; delay of >2 weeks due to drug-related toxicity in initiating Cycle 2; unable to complete at least 70% of the scheduled treatment (>six Debio 1143 skipped doses in Cycle 1) due to treatment-related toxicity; required dose reduction in Cycle 1 or on Cycle 2 Day 1 or requirement for treatment withdrawal due to treatment-related toxicity (even if not meeting other DLT criteria).
Time Frame Part A: Cycle 1 (28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Recommended phase 2 dose (RP2D) population included participants who received at least 70% of Debio 1143 (i.e., a maximum of 6 missed Debio 1143 doses) and at least one nivolumab dose as planned in Cycle 1.
Arm/Group Title Part A - Debio 1143 150 mg + Nivolumab Part A - Debio 1143 200 mg + Nivolumab
Hide Arm/Group Description:
Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Overall Number of Participants Analyzed 3 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Part B: Confirmed Objective Response Rate (ORR)
Hide Description ORR was determined per response evaluation criteria in solid tumors (RECIST) v1.1 and/or gynecologic cancer intergroup (GCIG) criteria (for Cohort 4). ORR was calculated as the percentage of participants with a confirmed objective response. A confirmed objective response is a confirmed best overall response of partial response (PR) or complete response (CR) recorded after the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first. CR is defined by the disappearance of all target lesions and reduction of any pathological lymph nodes in short axis to <10 millimeters (mm). PR is defined by at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameter.
Time Frame Part B: From the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first (up to approximately 2.05 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Arm/Group Title Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab
Hide Arm/Group Description:
Participants with SCLC received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCCHN received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Overall Number of Participants Analyzed 8 8 8 11
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.0
(0 to 37)
0.0
(0 to 37)
0.0
(0 to 37)
9.1
(0 to 41)
3.Secondary Outcome
Title Parts A and B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Including Laboratory Abnormalities Reported as TEAEs, and Serious Adverse Events (SAEs)
Hide Description An adverse event (AE) is any untoward medical occurrence in a clinical trial participant administered a medicinal product that does not necessarily have a causal relationship with this treatment. A TEAE is any new, related or non-related, undesirable medical occurrence or change of an existing condition in a participant that occurs during the treatment-emergent period, starting or worsening on or after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy - 1 day, whichever occurs first. An SAE is defined as any untoward medical occurrence that at any dose results in death; is life-threatening (i.e., puts the participant at immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect, or is otherwise medically significant.
Time Frame From the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Arm/Group Title Part A - Debio 1143 150 mg + Nivolumab Part A - Debio 1143 200 mg + Nivolumab Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab
Hide Arm/Group Description:
Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCLC received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCCHN received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Overall Number of Participants Analyzed 3 8 8 8 8 11
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
3
 100.0%
8
 100.0%
8
 100.0%
8
 100.0%
8
 100.0%
11
 100.0%
SAEs
0
   0.0%
8
 100.0%
0
   0.0%
6
  75.0%
5
  62.5%
5
  45.5%
4.Secondary Outcome
Title Parts A and B: Change From Baseline in Weight
Hide Description [Not Specified]
Time Frame From Baseline up to end of treatment (up to approximately 1.53 years in Part A and up to 1 year in Part B)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Overall number of participants analyzed indicates the number of participants with data available for analysis.
Arm/Group Title Part A - Debio 1143 150 mg + Nivolumab Part A - Debio 1143 200 mg + Nivolumab Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab
Hide Arm/Group Description:
Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCLC received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCCHN received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Overall Number of Participants Analyzed 3 4 7 3 4 8
Mean (Standard Deviation)
Unit of Measure: kilograms (kg)
-5.57  (5.705) -10.00  (9.416) -4.33  (3.888) -4.00  (6.557) -0.80  (5.415) -1.11  (1.680)
5.Secondary Outcome
Title Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Vital Signs
Hide Description Vital sign parameters assessed comprise of systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate. Markedly abnormal criteria for vital signs include SBP [millimeters of mercury (mmHg)]: ≤ 90 mmHg OR change from baseline ≤ -20 mmHg, ≥ 140 mmHg OR change from baseline ≥ 20 mmHg; DBP (mmHg): ≤ 60 mmHg OR change from baseline ≤ -20 mmHg, ≥ 90 mmHg OR change from baseline ≥ 20 mmHg; Heart rate [beats per minute (bpm)]: ≤ 50 bpm OR change from baseline ≤ -20 bpm, ≥ 100 bpm OR change from baseline ≥ 20 bpm.
Time Frame From Baseline up to end of treatment (up to approximately 1.53 years in Part A and up to 1 year in Part B)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Arm/Group Title Part A - Debio 1143 150 mg + Nivolumab Part A - Debio 1143 200 mg + Nivolumab Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab
Hide Arm/Group Description:
Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCLC received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCCHN received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Overall Number of Participants Analyzed 3 8 8 8 8 11
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Parts A and B: Number of Participants With Change From Baseline in Temperature Reported as TEAEs
Hide Description Change from baseline in temperature reported as TEAEs included pyrexia. A TEAE is any new, related or non-related, undesirable medical occurrence or change of an existing condition in a participant that occurs during the treatment-emergent period, starting or worsening on or after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy - 1 day, whichever occurs first.
Time Frame From Baseline up to end of treatment (up to approximately 1.53 years in Part A and up to 1 year in Part B)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Arm/Group Title Part A - Debio 1143 150 mg + Nivolumab Part A - Debio 1143 200 mg + Nivolumab Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab
Hide Arm/Group Description:
Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCLC received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCCHN received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Overall Number of Participants Analyzed 3 8 8 8 8 11
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2
  25.0%
1
  12.5%
1
  12.5%
0
   0.0%
3
  27.3%
7.Secondary Outcome
Title Parts A and B: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiogram (ECG) Readings
Hide Description ECG parameters comprised of PR Interval [millisecond (msec)], QRS Interval (msec), QT Interval (msec), QTcB Interval (msec), QTcF Interval (msec), heart rate (HR) (bpm), RR interval (msec), derived HR (msec), calculated as 60000/RR interval [for data checking only: should be within 5% of HR]. Marked abnormal criteria for ECG parameters included absolute values QRS interval: < 50 msec, > 110 msec; absolute values for QT interval, QTcB interval: >450 msec, > 480 msec, > 500 msec, QTcF: > 480 msec, > 500 msec; change from baseline values for QTcB interval, and QTcF: >30 msec increase from baseline, >60 msec increase from baseline. Data for highest on-treatment change from baseline as per the markedly abnormal criteria for ECG parameters are reported. On-treatment is the period of time between the first and last administration of any study drug. Participants with at least one markedly abnormal change from baseline value in the above categories are reported.
Time Frame From Baseline up to end of treatment (up to approximately 1.53 years in Part A and up to 1 year in Part B)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Overall number of participants analyzed indicates the number of participants available for analysis.
Arm/Group Title Part A - Debio 1143 150 mg + Nivolumab Part A - Debio 1143 200 mg + Nivolumab Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab
Hide Arm/Group Description:
Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCLC received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCCHN received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Overall Number of Participants Analyzed 2 8 8 8 8 11
Measure Type: Count of Participants
Unit of Measure: Participants
QRS duration: >110 msec
0
   0.0%
3
  37.5%
1
  12.5%
1
  12.5%
2
  25.0%
0
   0.0%
QT Interval: >450 msec
0
   0.0%
1
  12.5%
2
  25.0%
1
  12.5%
3
  37.5%
0
   0.0%
QT Interval: >480 msec
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
QTcB Interval: >450 msec
2
 100.0%
2
  25.0%
3
  37.5%
5
  62.5%
1
  12.5%
5
  45.5%
QTcB Interval: >480 msec
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
1
   9.1%
QTcB Interval: >500 msec
0
   0.0%
1
  12.5%
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
QTcB Interval: >30 msec increase from baseline
0
   0.0%
4
  50.0%
3
  37.5%
5
  62.5%
3
  37.5%
6
  54.5%
QTcB Interval: >60 msec increase from baseline
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
QTcB Interval: >30 msec or >60 msec increase from baseline
0
   0.0%
4
  50.0%
3
  37.5%
6
  75.0%
3
  37.5%
6
  54.5%
QTcF Interval: >480 msec
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
QTcF Interval: >500 msec
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
QTcF Interval: >30 msec increase from baseline
0
   0.0%
1
  12.5%
2
  25.0%
3
  37.5%
1
  12.5%
4
  36.4%
QTcF Interval: >60 msec increase from baseline
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Parts A and B: Number of Participants With Shift From Baseline to Worst On-Treatment Value in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Hide Description The ECOG-PS was used to assess the effect of disease progression on participants' daily activities. ECOG-PS is graded as follows: Grade 0 - fully active, able to carry on all pre-disease performance without restriction; Grade 1 - restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; Grade 2 - ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50% of waking hours; Grade 3 - capable of only limited self-care, confined to bed or chair for more than 50% of waking hours; Grade 4 - completely disabled, cannot carry on any self-care, totally confined to bed or chair; Grade 5 - dead. Shift values from baseline grade to worst on-treatment grade and missing values were reported.
Time Frame From Baseline up to end of treatment (up to approximately 1.53 years in Part A and up to 1 year in Part B)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Arm/Group Title Part A - Debio 1143 150 mg + Nivolumab Part A - Debio 1143 200 mg + Nivolumab Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab
Hide Arm/Group Description:
Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCLC received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCCHN received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Overall Number of Participants Analyzed 3 8 8 8 8 11
Measure Type: Count of Participants
Unit of Measure: Participants
Shift From Grade 0 to Grade 0
1
  33.3%
3
  37.5%
0
   0.0%
2
  25.0%
1
  12.5%
1
   9.1%
Shift From Grade 0 to Grade 1
0
   0.0%
2
  25.0%
3
  37.5%
0
   0.0%
2
  25.0%
4
  36.4%
Shift From Grade 0 to Grade 2
0
   0.0%
1
  12.5%
2
  25.0%
0
   0.0%
1
  12.5%
0
   0.0%
Shift From Grade 0 to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
Shift From Grade 1 to Grade 1
2
  66.7%
1
  12.5%
2
  25.0%
3
  37.5%
2
  25.0%
5
  45.5%
Shift From Grade 1 to Grade 2
0
   0.0%
1
  12.5%
1
  12.5%
1
  12.5%
1
  12.5%
0
   0.0%
Shift From Grade 1 to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
2
  25.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   9.1%
9.Secondary Outcome
Title Parts A and B: Number of Participants With TEAEs Including Laboratory Abnormalities Leading to Treatment Discontinuations and Dose Modifications
Hide Description [Not Specified]
Time Frame From the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Arm/Group Title Part A - Debio 1143 150 mg + Nivolumab Part A - Debio 1143 200 mg + Nivolumab Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab
Hide Arm/Group Description:
Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCLC received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCCHN received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Overall Number of Participants Analyzed 3 8 8 8 8 11
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs Leading to Discontinuation of Debio 1143
1
  33.3%
1
  12.5%
0
   0.0%
3
  37.5%
1
  12.5%
2
  18.2%
TEAEs Leading to Discontinuation of Nivolumab
1
  33.3%
1
  12.5%
0
   0.0%
3
  37.5%
1
  12.5%
2
  18.2%
TEAEs Leading to Dose Modification of Debio 1143
2
  66.7%
5
  62.5%
5
  62.5%
5
  62.5%
3
  37.5%
4
  36.4%
TEAEs Leading to Dose Modification of Nivolumab
2
  66.7%
6
  75.0%
4
  50.0%
5
  62.5%
1
  12.5%
4
  36.4%
10.Secondary Outcome
Title Part A: Confirmed Objective Response Rate (ORR)
Hide Description ORR was determined per RECIST v1.1. ORR was calculated as the percentage of participants with a confirmed objective response. A confirmed objective response is a confirmed best overall response of PR or CR recorded after the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first. CR is defined by the disappearance of all target lesions and reduction of any pathological lymph nodes in short axis to <10 mm. PR is defined by at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameter.
Time Frame Part A: From the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first (up to approximately 2.08 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Arm/Group Title Part A - Debio 1143 150 mg + Nivolumab Part A - Debio 1143 200 mg + Nivolumab
Hide Arm/Group Description:
Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Overall Number of Participants Analyzed 3 8
Measure Type: Number
Unit of Measure: percentage of participants
0.0 12.5
11.Secondary Outcome
Title Parts A and B: Unconfirmed Objective Response Rate (uORR)
Hide Description uORR was calculated as the percentage of participants with unconfirmed objective response per RECIST v1.1. Unconfirmed objective response is an unconfirmed best overall response of PR or CR. Objective response was derived as any PR or CR recorded after the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first. CR is defined by the disappearance of all target lesions and reduction of any pathological lymph nodes in short axis to <10 mm. PR is defined by at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameter.
Time Frame From the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first (up to approximately 2.08 years in Part A and 2.05 years in Part B)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Arm/Group Title Part A - Debio 1143 150 mg + Nivolumab Part A - Debio 1143 200 mg + Nivolumab Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab
Hide Arm/Group Description:
Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCLC received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCCHN received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Overall Number of Participants Analyzed 3 8 8 8 8 11
Measure Type: Number
Unit of Measure: percentage of participants
0.0 25.0 0.0 0.0 0.0 9.1
12.Secondary Outcome
Title Parts A and B: Disease Control Rate (DCR)
Hide Description DCR was calculated as the percentage of participants with disease control. Disease control was derived as any CR, PR, or stable disease reported during the study. CR is defined by the disappearance of all target lesions and reduction of any pathological lymph nodes in short axis to <10 mm. PR is defined by at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameter.
Time Frame From the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first (up to approximately 2.08 years in Part A and 2.05 years in Part B)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Arm/Group Title Part A - Debio 1143 150 mg + Nivolumab Part A - Debio 1143 200 mg + Nivolumab Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab
Hide Arm/Group Description:
Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCLC received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCCHN received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Overall Number of Participants Analyzed 3 8 8 8 8 11
Measure Type: Number
Unit of Measure: percentage of participants
66.7 50.0 25.0 75.0 37.5 45.5
13.Secondary Outcome
Title Parts A and B: Median Duration of Response (DOR)
Hide Description DOR is defined as the time, in months, between date of the initial response (PR or CR) or date of first reduction of 50% in carbohydrate antigen 125 (CA-125), and date of the first documented disease progression or death due to any cause, whichever occurs first. CR is defined by the disappearance of all target lesions and reduction of any pathological lymph nodes in short axis to <10 mm. PR is defined by at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameter. Data is reported as Kaplan-Meier product-limit estimates.
Time Frame From the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first (up to approximately 2.08 years in Part A and 2.05 years in Part B)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Overall number of participants analyzed indicates censored participants with at least a CR or PR.
Arm/Group Title Part A - Debio 1143 150 mg + Nivolumab Part A - Debio 1143 200 mg + Nivolumab Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab
Hide Arm/Group Description:
Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCLC received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCCHN received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Overall Number of Participants Analyzed 0 2 0 0 0 1
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
The median and the 95% confidence interval (CI) were not estimable due to insufficient number of participants with events.
14.Secondary Outcome
Title Parts A and B: Progression Free Survival (PFS)
Hide Description PFS duration is defined as the time, in months, elapsed between treatment initiation and tumor progression or death from any cause, whichever occurs first.
Time Frame From the start of study treatment until disease progression/recurrence or death from any cause, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Arm/Group Title Part A - Debio 1143 150 mg + Nivolumab Part A - Debio 1143 200 mg + Nivolumab Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab
Hide Arm/Group Description:
Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCLC received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCCHN received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Overall Number of Participants Analyzed 3 8 8 8 8 11
Median (95% Confidence Interval)
Unit of Measure: months
2.3 [1] 
(1.7 to NA)
2.3 [1] 
(0.3 to NA)
1.8
(1.0 to 3.2)
1.9
(0.9 to 3.5)
1.2
(0.8 to 4.2)
1.8
(1.3 to 5.2)
[1]
The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
15.Secondary Outcome
Title Parts A and B: PFS Rate at Months 6 and 12
Hide Description PFS is defined as duration elapsed between treatment initiation and tumor progression or death from any cause, whichever occurs first. Data for PFS rate is reported as Kaplan-Meier product-limit estimates and includes Brookmeyer-Crowley confidence intervals.
Time Frame Months 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Number analyzed indicates the number of participants analyzed at the given time points. No participants were analyzed at Month 12 in Part B.
Arm/Group Title Part A - Debio 1143 150 mg + Nivolumab Part A - Debio 1143 200 mg + Nivolumab Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab
Hide Arm/Group Description:
Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCLC received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCCHN received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Overall Number of Participants Analyzed 3 8 8 8 8 11
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
Month 6 Number Analyzed 3 participants 8 participants 8 participants 8 participants 8 participants 11 participants
0.0
(0.0 to 0.0)
0.2
(0.0 to 0.5)
0.1
(0.0 to 0.4)
0.0
(0.0 to 0.0)
0.1
(0.0 to 0.4)
0.2
(0.0 to 0.4)
Month 12 Number Analyzed 3 participants 8 participants 0 participants 0 participants 0 participants 0 participants
0.0
(0.0 to 0.0)
0.2
(0.0 to 0.5)
16.Secondary Outcome
Title Parts A and B: Overall Survival (OS)
Hide Description OS is defined as the time elapsed, in months, between treatment initiation and death from any cause.
Time Frame From the start of study treatment until death from any cause, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
Arm/Group Title Part A - Debio 1143 150 mg + Nivolumab Part A - Debio 1143 200 mg + Nivolumab Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab
Hide Arm/Group Description:
Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCLC received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCCHN received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Overall Number of Participants Analyzed 3 8 8 8 8 11
Median (95% Confidence Interval)
Unit of Measure: months
13.8 [1] 
(12.5 to NA)
NA [1] 
(1.9 to NA)
17.5 [1] 
(3.8 to NA)
4.7
(0.9 to 13.4)
5.2 [1] 
(1.9 to NA)
11.7 [1] 
(3.9 to NA)
[1]
The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
17.Secondary Outcome
Title Parts A and B: OS Rate at Months 12 and 18
Hide Description OS is defined as the time elapsed, in months, between treatment initiation and death from any cause. Data for OS rate is reported as Kaplan-Meier product-limit estimates and includes Brookmeyer-Crowley confidence intervals.
Time Frame Months 12 and 18
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Number analyzed indicates the number of participants analyzed at the given time points.
Arm/Group Title Part A - Debio 1143 150 mg + Nivolumab Part A - Debio 1143 200 mg + Nivolumab Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab
Hide Arm/Group Description:
Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCLC received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCCHN received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Overall Number of Participants Analyzed 3 8 8 8 8 11
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
Month 12 Number Analyzed 3 participants 8 participants 8 participants 8 participants 8 participants 11 participants
1.0
(1.0 to 1.0)
0.5
(0.2 to 0.8)
0.9
(0.4 to 1.0)
0.3
(0.0 to 0.6)
0.4
(0.1 to 0.7)
0.4
(0.1 to 0.7)
Month 18 Number Analyzed 1 participants 1 participants 8 participants 8 participants 8 participants 11 participants
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
0.5
(0.2 to 0.8)
0.1
(0.0 to 0.4)
0.4
(0.1 to 0.7)
0.3
(0.0 to 0.6)
[1]
The median and 95% CI were not estimable due to insufficient number of participants with events.
18.Secondary Outcome
Title Part A: Area Under the Curve From Time 0 to 4 Hours (AUC0-4H) of Debio 1143 and Debio 1143-MET1
Hide Description [Not Specified]
Time Frame Cycle 1: predose, 0.5, 1.5, 4 hours post-dose on Days 1 and 15, predose, 1.5, 4 hours post-dose on Days 8 and 22; Cycle 3: predose, 0.5, 1.5, 4 hours post-dose on Day 1 and predose, 1.5, 4 hours post-dose on Day 15 (each cycle=28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Number analyzed indicates the number of participants with available data for analysis at the given timepoint.
Arm/Group Title Part A - Debio 1143 150 mg + Nivolumab Part A - Debio 1143 200 mg + Nivolumab
Hide Arm/Group Description:
Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Overall Number of Participants Analyzed 3 8
Mean (Standard Deviation)
Unit of Measure: hours*nanograms per milliliter (h*ng/mL)
Debio 1143: Cycle 1 Day 1 Number Analyzed 3 participants 8 participants
6200.28  (330.246) 4907.15  (2496.914)
Debio 1143: Cycle 1 Day 8 Number Analyzed 3 participants 7 participants
4321.40  (1127.611) 5861.53  (3764.659)
Debio 1143: Cycle 1 Day 15 Number Analyzed 3 participants 7 participants
5081.21  (868.905) 5114.03  (3168.408)
Debio 1143: Cycle 1 Day 22 Number Analyzed 3 participants 5 participants
4517.00  (3539.938) 4086.09  (2516.921)
Debio 1143: Cycle 3 Day 1 Number Analyzed 3 participants 5 participants
4053.97  (3005.430) 6844.02  (4940.667)
Debio 1143: Cycle 3 Day 15 Number Analyzed 2 participants 4 participants
4725.37  (2033.252) 5934.72  (2251.520)
Debio 1143-MET1: Cycle 1 Day 1 Number Analyzed 3 participants 8 participants
2624.48  (953.275) 1662.25  (957.856)
Debio 1143-MET1: Cycle 1 Day 8 Number Analyzed 3 participants 7 participants
3884.59  (565.589) 5133.24  (3794.465)
Debio 1143-MET1: Cycle 1 Day 15 Number Analyzed 3 participants 7 participants
2104.06  (325.456) 1673.48  (986.138)
Debio 1143-MET1: Cycle 1 Day 22 Number Analyzed 3 participants 5 participants
3634.33  (1591.770) 5064.61  (4242.170)
Debio 1143-MET1: Cycle 3 Day 1 Number Analyzed 3 participants 5 participants
983.62  (501.515) 2617.59  (2250.993)
Debio 1143-MET1: Cycle 3 Day 15 Number Analyzed 2 participants 4 participants
3255.14  (513.699) 2208.80  (775.572)
19.Secondary Outcome
Title Part B: AUC0-4H of Debio 1143 and Debio 1143-MET1
Hide Description [Not Specified]
Time Frame Cycle 1: predose, 1.5, 4 hours post-dose on Days 1 and 22; Cycle 3: predose, 1.5, 4 hours post-dose on Day 1 (each cycle = 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Overall number of participants analyzed indicates number of participants available for analysis. Number analyzed indicates the number of participants with available data for analysis at the given timepoint.
Arm/Group Title Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab
Hide Arm/Group Description:
Participants with SCLC received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCCHN received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Overall Number of Participants Analyzed 7 7 8 10
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
Debio 1143: Cycle 1 Day 1 Number Analyzed 7 participants 7 participants 8 participants 10 participants
6842.88  (3251.994) 5552.70  (4559.658) 5149.10  (1922.588) 7619.75  (3287.399)
Debio 1143: Cycle 1 Day 22 Number Analyzed 7 participants 6 participants 5 participants 8 participants
7167.67  (4161.553) 5668.59  (3536.016) 3218.09  (1137.952) 6801.02  (1841.871)
Debio 1143: Cycle 3 Day 1 Number Analyzed 2 participants 2 participants 3 participants 7 participants
5674.83  (757.917) 3248.39  (3165.907) 2117.23  (970.849) 5920.77  (2206.953)
Debio 1143-MET1: Cycle 1 Day 1 Number Analyzed 7 participants 5 participants 8 participants 10 participants
2737.56  (1280.628) 3440.08  (2274.864) 2255.49  (1153.863) 3140.29  (1139.965)
Debio 1143-MET1: Cycle 1 Day 22 Number Analyzed 7 participants 6 participants 5 participants 8 participants
5938.44  (2187.477) 10100.42  (3889.091) 5404.44  (4032.522) 7085.47  (5196.199)
Debio 1143-MET1: Cycle 3 Day 1 Number Analyzed 2 participants 2 participants 3 participants 7 participants
3409.44  (2059.973) 1587.21  (1838.618) 2381.90  (2767.733) 2128.83  (1581.498)
20.Secondary Outcome
Title Part A: Area Under the Curve From Time 0 to 8 Hours (AUC0-8H) of Debio 1143 and Debio 1143-MET1
Hide Description [Not Specified]
Time Frame Cycle 1: predose, 0.5, 1.5, 4, 8 hours post-dose on Days 1 and 15, and predose, 1.5, 4, 8 hours post-dose on Day 8; Cycle 3: predose, 0.5, 1.5, 4, 8 hours post-dose on Day 1 and predose, 1.5, 4, 8 hours post-dose on Day 15 (each cycle = 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Overall number of participants analyzed indicates number of participants available for analysis. Number analyzed indicates the number of participants with available data for analysis at the given timepoint.
Arm/Group Title Part A - Debio 1143 150 mg + Nivolumab Part A - Debio 1143 200 mg + Nivolumab
Hide Arm/Group Description:
Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Overall Number of Participants Analyzed 3 7
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
Debio 1143: Cycle 1 Day 1 Number Analyzed 3 participants 7 participants
8954.45  (1347.640) 8497.84  (3213.996)
Debio 1143: Cycle 1 Day 8 Number Analyzed 3 participants 7 participants
6699.18  (1315.190) 9437.55  (6036.801)
Debio 1143: Cycle 1 Day 15 Number Analyzed 3 participants 7 participants
7280.65  (945.078) 8024.00  (5036.125)
Debio 1143: Cycle 3 Day 1 Number Analyzed 2 participants 4 participants
4623.23  (2089.994) 10627.09  (6520.082)
Debio 1143: Cycle 3 Day 15 Number Analyzed 2 participants 4 participants
6864.95  (1815.779) 9072.05  (3529.268)
Debio 1143-MET1: Cycle 1 Day 1 Number Analyzed 3 participants 7 participants
5940.42  (2217.500) 5128.38  (2307.490)
Debio 1143-MET1: Cycle 1 Day 8 Number Analyzed 3 participants 7 participants
7743.38  (1258.029) 10646.90  (8177.450)
Debio 1143-MET1: Cycle 1 Day 15 Number Analyzed 3 participants 7 participants
4921.26  (741.691) 4304.95  (2105.077)
Debio 1143-MET1: Cycle 3 Day 1 Number Analyzed 2 participants 4 participants
2315.46  (1568.487) 6632.52  (6610.503)
Debio 1143-MET1: Cycle 3 Day 15 Number Analyzed 2 participants 4 participants
6011.84  (429.313) 6225.18  (2315.768)
21.Secondary Outcome
Title Part A: Maximum Observed Concentration (Cmax) of Debio 1143 and Debio 1143-MET1
Hide Description [Not Specified]
Time Frame Cycle 1: Predose,0.5,1.5,4,8 hours post-dose (Days 1 and 15), predose,1.5,4,8 hours post-dose (Day 8), predose,1.5,4 hours post-dose (Day 22); Cycle 3: predose,0.5,1.5,4,8 hours post-dose (Day 1), predose,1.5,4,8 hours post-dose (Day 15) (Cycle=28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Number analyzed indicates the number of participants with available data for analysis at the given timepoint.
Arm/Group Title Part A - Debio 1143 150 mg + Nivolumab Part A - Debio 1143 200 mg + Nivolumab
Hide Arm/Group Description:
Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Overall Number of Participants Analyzed 3 8
Mean (Standard Deviation)
Unit of Measure: nanograms per milliliter (ng/mL)
Debio 1143: Cycle 1 Day 1 Number Analyzed 3 participants 8 participants
3063.33  (771.838) 2020.63  (1015.945)
Debio 1143: Cycle 1 Day 8 Number Analyzed 3 participants 7 participants
1656.67  (568.624) 2132.71  (1346.859)
Debio 1143: Cycle 1 Day 15 Number Analyzed 3 participants 7 participants
2426.67  (567.656) 1956.29  (1137.771)
Debio 1143: Cycle 1 Day 22 Number Analyzed 3 participants 5 participants
2037.00  (1637.415) 1528.96  (910.236)
Debio 1143: Cycle 3 Day 1 Number Analyzed 3 participants 5 participants
1954.00  (1119.459) 3071.00  (1928.848)
Debio 1143: Cycle 3 Day 15 Number Analyzed 2 participants 4 participants
1970.00  (1244.508) 2265.00  (886.397)
Debio 1143-MET1: Cycle 1 Day 1 Number Analyzed 3 participants 8 participants
989.67  (344.515) 972.50  (489.140)
Debio 1143-MET1: Cycle 1 Day 8 Number Analyzed 3 participants 7 participants
1193.33  (222.336) 1733.23  (1184.636)
Debio 1143-MET1: Cycle 1 Day 15 Number Analyzed 3 participants 7 participants
868.00  (117.051) 915.86  (390.840)
Debio 1143-MET1: Cycle 1 Day 22 Number Analyzed 3 participants 5 participants
1088.33  (581.758) 1658.68  (1339.093)
Debio 1143-MET1: Cycle 3 Day 1 Number Analyzed 3 participants 5 participants
611.00  (376.227) 1343.60  (1078.400)
Debio 1143-MET1: Cycle 3 Day 15 Number Analyzed 2 participants 4 participants
1177.00  (272.943) 1148.50  (458.398)
22.Secondary Outcome
Title Part B: Cmax of Debio 1143 and Debio 1143-MET1
Hide Description [Not Specified]
Time Frame Cycle 1: predose, 1.5, 4 hours post-dose on Days 1 and 22; Cycle 3: predose, 1.5, 4 hours post-dose on Day 1 (each cycle = 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Number analyzed indicates the number of participants with available data for analysis at the given timepoint.
Arm/Group Title Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab
Hide Arm/Group Description:
Participants with SCLC received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCCHN received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Overall Number of Participants Analyzed 8 8 8 11
Mean (Standard Deviation)
Unit of Measure: ng/mL
Debio 1143: Cycle 1 Day 1 Number Analyzed 8 participants 8 participants 8 participants 11 participants
2839.5  (1293.43) 2266.1  (1830.74) 2331.3  (823.28) 2850.0  (1413.87)
Debio 1143: Cycle 1 Day 22 Number Analyzed 8 participants 6 participants 5 participants 10 participants
2786.3  (1591.66) 2065.8  (1205.31) 1327.0  (416.30) 2891.0  (860.28)
Debio 1143: Cycle 3 Day 1 Number Analyzed 3 participants 2 participants 3 participants 7 participants
2183.3  (496.42) 1726.0  (1094.60) 975.3  (179.70) 2271.4  (954.80)
Debio 1143-MET1: Cycle 1 Day 1 Number Analyzed 8 participants 8 participants 8 participants 11 participants
1077.38  (473.925) 1070.71  (808.979) 1190.00  (439.686) 1320.00  (483.919)
Debio 1143-MET1: Cycle 1 Day 22 Number Analyzed 8 participants 6 participants 5 participants 10 participants
1888.50  (668.598) 2886.67  (915.394) 1782.80  (1074.434) 2289.10  (1414.128)
Debio 1143-MET1: Cycle 3 Day 1 Number Analyzed 3 participants 2 participants 3 participants 7 participants
808.67  (748.505) 738.00  (724.077) 965.33  (982.152) 891.29  (488.887)
23.Secondary Outcome
Title Part A: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1
Hide Description [Not Specified]
Time Frame Cycle 1: predose on Days 3, 8, 15, 17 and 22; Cycle 3: predose on Days 1, 3, 15, 17; Cycle 6: predose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Overall number of participants analyzed indicates number of participants available for analysis. Number analyzed indicates the number of participants with available data for analysis at the given timepoint.
Arm/Group Title Part A - Debio 1143 150 mg + Nivolumab Part A - Debio 1143 200 mg + Nivolumab
Hide Arm/Group Description:
Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Overall Number of Participants Analyzed 3 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
Debio 1143: Cycle 1 Day 3 Number Analyzed 3 participants 6 participants
113.10  (31.892) 169.50  (120.014)
Debio 1143: Cycle 1 Day 8 Number Analyzed 3 participants 6 participants
118.27  (30.751) 173.35  (113.797)
Debio 1143: Cycle 1 Day 15 Number Analyzed 1 participants 5 participants
7.34 [1]   (NA) 5.22  (2.844)
Debio 1143: Cycle 1 Day 17 Number Analyzed 3 participants 6 participants
99.37  (19.290) 133.57  (86.239)
Debio 1143: Cycle 1 Day 22 Number Analyzed 3 participants 5 participants
83.53  (19.630) 173.70  (135.079)
Debio 1143: Cycle 3 Day 1 Number Analyzed 1 participants 2 participants
10.20 [1]   (NA) 4.72  (0.410)
Debio 1143: Cycle 3 Day 3 Number Analyzed 3 participants 2 participants
110.47  (13.808) 97.20  (37.901)
Debio 1143: Cycle 3 Day 15 Number Analyzed 0 participants 2 participants
8.71  (6.640)
Debio 1143: Cycle 3 Day 17 Number Analyzed 2 participants 3 participants
118.00  (16.971) 136.37  (81.772)
Debio 1143: Cycle 6 Day 1 Number Analyzed 0 participants 1 participants
5.31 [1]   (NA)
Debio 1143-MET1: Cycle 1 Day 3 Number Analyzed 3 participants 6 participants
453.33  (180.059) 620.10  (434.376)
Debio 1143-MET1: Cycle 1 Day 8 Number Analyzed 3 participants 6 participants
387.00  (145.812) 793.65  (953.516)
Debio 1143-MET1: Cycle 1 Day 15 Number Analyzed 1 participants 3 participants
33.30 [1]   (NA) 6.39  (3.241)
Debio 1143-MET1: Cycle 1 Day 17 Number Analyzed 3 participants 6 participants
543.00  (154.182) 531.93  (560.633)
Debio 1143-MET1: Cycle 1 Day 22 Number Analyzed 3 participants 5 participants
367.33  (289.588) 805.78  (961.228)
Debio 1143-MET1: Cycle 3 Day 1 Number Analyzed 1 participants 2 participants
6.97 [1]   (NA) 23.65  (27.655)
Debio 1143-MET1: Cycle 3 Day 3 Number Analyzed 3 participants 2 participants
443.67  (172.631) 1157.50  (1304.612)
Debio 1143-MET1: Cycle 3 Day 15 Number Analyzed 0 participants 2 participants
13.55  (9.687)
Debio 1143-MET1: Cycle 3 Day 17 Number Analyzed 2 participants 3 participants
611.00  (322.441) 639.67  (387.727)
Debio 1143-MET1: Cycle 6 Day 1 Number Analyzed 0 participants 1 participants
3.15 [1]   (NA)
[1]
The standard deviation cannot be calculated for 1 participant.
24.Secondary Outcome
Title Part B: Trough Concentration (Cmin) of Debio 1143 and Debio 1143-MET1
Hide Description [Not Specified]
Time Frame Cycle 1: predose on Days 8 and 22; Cycle 3: predose on Day 1 (each cycle = 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Overall number of participants analyzed indicates number of participants available for analysis. Number analyzed indicates the number of participants with available data for analysis at the given timepoint.
Arm/Group Title Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab
Hide Arm/Group Description:
Participants with SCLC received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCCHN received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Overall Number of Participants Analyzed 8 8 7 10
Mean (Standard Deviation)
Unit of Measure: ng/mL
Debio 1143: Cycle 1 Day 8 Number Analyzed 6 participants 7 participants 7 participants 10 participants
198.05  (143.494) 167.20  (112.649) 192.86  (130.457) 143.39  (44.663)
Debio 1143: Cycle 1 Day 22 Number Analyzed 8 participants 6 participants 5 participants 10 participants
150.29  (80.118) 221.60  (140.039) 130.92  (50.555) 146.39  (50.852)
Debio 1143: Cycle 3 Day 1 Number Analyzed 2 participants 2 participants 2 participants 5 participants
3.24  (0.721) 11.08  (12.056) 3.50  (0.318) 4.94  (2.137)
Debio 1143-MET: Cycle 1 Day 8 Number Analyzed 6 participants 8 participants 7 participants 10 participants
693.33  (983.009) 1917.89  (1826.669) 1005.20  (1150.843) 1118.40  (710.330)
Debio 1143-MET1: Cycle 1 Day 22 Number Analyzed 8 participants 6 participants 5 participants 10 participants
658.50  (557.846) 2103.33  (1410.308) 830.20  (827.444) 1113.04  (811.962)
Debio 1143-MET1: Cycle 3 Day 1 Number Analyzed 2 participants 2 participants 0 participants 3 participants
2.84  (0.255) 14.35  (11.809) 10.30  (3.751)
25.Secondary Outcome
Title Part A: Serum Trough Concentration of Nivolumab
Hide Description [Not Specified]
Time Frame Cycle 1: predose, 1.5, 8 hours post-dose on Day 15; Cycle 3: predose, 0.5, 1.5, 8 hours post-dose on Day 1 and predose, 1.5 hours post-dose on Day 15 (each cycle = 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Overall number of participants analyzed indicates number of participants available for analysis. Number analyzed indicates the number of participants with available data for analysis at the given timepoint.
Arm/Group Title Part A - Debio 1143 150 mg + Nivolumab Part A - Debio 1143 200 mg + Nivolumab
Hide Arm/Group Description:
Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Overall Number of Participants Analyzed 3 7
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 1 Day 15 Number Analyzed 3 participants 7 participants
21366.67  (4808.673) 22271.43  (7553.744)
Cycle 3 Day 1 Number Analyzed 1 participants 1 participants
43500.00 [1]   (NA) 32700.00 [1]   (NA)
Cycle 3 Day 15 Number Analyzed 0 participants 1 participants
27100.00 [1]   (NA)
[1]
The standard deviation cannot be calculated for 1 participant.
26.Secondary Outcome
Title Part B: Serum Trough Concentration of Nivolumab
Hide Description [Not Specified]
Time Frame Cycle 1: predose, 1.5 hours post-dose on Day 15; Cycle 3: predose, 1.5 hours post-dose on Days 1 and Day 15; Cycle 6: predose on Day 1 (each cycle = 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Overall number of participants analyzed indicates number of participants available for analysis. Number analyzed indicates the number of participants with available data for analysis at the given timepoint.
Arm/Group Title Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab
Hide Arm/Group Description:
Participants with SCLC received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCCHN received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Overall Number of Participants Analyzed 8 7 8 10
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 1 Day 15 Number Analyzed 8 participants 7 participants 8 participants 10 participants
21312.5  (2942.51) 25414.3  (8766.68) 33725.0  (17751.28) 22332.0  (8864.61)
Cycle 3 Day 1 Number Analyzed 1 participants 1 participants 0 participants 6 participants
34100.0 [1]   (NA) 40600.0 [1]   (NA) 43866.7  (11670.08)
Cycle 3 Day 15 Number Analyzed 0 participants 1 participants 0 participants 4 participants
45400.0 [1]   (NA) 58400.0  (10492.22)
Cycle 6 Day 1 Number Analyzed 0 participants 1 participants 0 participants 0 participants
40400.0 [1]   (NA)
[1]
The standard deviation cannot be calculated for 1 participant.
27.Secondary Outcome
Title Parts A and B: Time to Response (TTR)
Hide Description The average of the time taken in days for PR is reported. PR is defined by at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameter.
Time Frame From the start of study treatment until disease progression/recurrence was documented, a new systemic anti-cancer therapy was started or analysis cut-off, whichever occurred first (up to approximately 2.08 years in Part A and 2.05 years in Part B)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least one dose of any study drug. Overall number of participants analyzed indicates the number of participants with at least a CR or PR.
Arm/Group Title Part A - Debio 1143 150 mg + Nivolumab Part A - Debio 1143 200 mg + Nivolumab Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab
Hide Arm/Group Description:
Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCLC received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with SCCHN received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
Overall Number of Participants Analyzed 0 2 0 0 0 1
Mean (Full Range)
Unit of Measure: days
82
(56 to 108)
52
(52 to 52)
Time Frame From after the first study drug administration and up to 5 months after last nivolumab infusion, or the earliest date of new anticancer therapy -1 day, whichever occurs first (up to approximately 2.08 years in Part A and 2.05 years in Part B)
Adverse Event Reporting Description Safety analysis set included all participants who were enrolled and received at least one dose of any study drug.
 
Arm/Group Title Part A - Debio 1143 150 mg + Nivolumab Part A - Debio 1143 200 mg + Nivolumab Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab
Hide Arm/Group Description Participants received Debio 1143, 150 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles. Participants received Debio 1143, 200 mg capsules, orally once on Days 1 to 10 and Days 15 to 24 of each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles. Participants with SCLC received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles. Participants with SCCHN received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles. Participants with GI cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles. Participants with gynecologic cancers received Debio 1143, 200 mg capsules, orally once on Days 1 to 28 in each 28-day treatment cycle along with nivolumab 240 mg, IV infusion on Days 1 and 15 of each 28-day treatment cycle allowed for a maximum of 26 cycles.
All-Cause Mortality
Part A - Debio 1143 150 mg + Nivolumab Part A - Debio 1143 200 mg + Nivolumab Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/3 (66.67%)   4/8 (50.00%)   5/8 (62.50%)   7/8 (87.50%)   6/8 (75.00%)   7/11 (63.64%) 
Hide Serious Adverse Events
Part A - Debio 1143 150 mg + Nivolumab Part A - Debio 1143 200 mg + Nivolumab Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   8/8 (100.00%)   0/8 (0.00%)   6/8 (75.00%)   5/8 (62.50%)   5/11 (45.45%) 
Gastrointestinal disorders             
Abdominal pain † 1  0/3 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/11 (0.00%) 
Dysphagia † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/11 (0.00%) 
Pancreatitis acute † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/11 (0.00%) 
General disorders             
Disease progression † 1  0/3 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/11 (0.00%) 
Pyrexia † 1  0/3 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Fatigue † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  0/8 (0.00%)  0/11 (0.00%) 
Hepatobiliary disorders             
Bile duct stone † 1  0/3 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Biliary obstruction † 1  0/3 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Hepatic failure † 1  0/3 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Hyperbilirubinaemia † 1  0/3 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Portal vein thrombosis † 1  0/3 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Immune system disorders             
Drug hypersensitivity † 1  0/3 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Infections and infestations             
Upper respiratory tract infection † 1  0/3 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Cellulitis † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Pneumonia † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/11 (0.00%) 
Sepsis † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/11 (0.00%) 
Metabolism and nutrition disorders             
Hypercalcaemia † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Hyponatraemia † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/11 (0.00%) 
Musculoskeletal and connective tissue disorders             
Myositis † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Glioblastoma † 1  0/3 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Malignant neoplasm progression † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/11 (0.00%) 
Nervous system disorders             
Disturbance in attention † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Renal and urinary disorders             
Acute kidney injury † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Reproductive system and breast disorders             
Pelvic pain † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Respiratory, thoracic and mediastinal disorders             
Dyspnoea † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/11 (0.00%) 
Pleural effusion † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/11 (0.00%) 
Pulmonary embolism † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/11 (0.00%) 
Respiratory failure † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  0/8 (0.00%)  0/11 (0.00%) 
1
Term from vocabulary, MedDRA (24.0)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part A - Debio 1143 150 mg + Nivolumab Part A - Debio 1143 200 mg + Nivolumab Part B - Cohort 1 (SCLC): Debio 1143 200 mg + Nivolumab Part B - Cohort 2 (SCCHN): Debio 1143 200 mg + Nivolumab Part B - Cohort 3 (GI Cancers): Debio 1143 200 mg + Nivolumab Part B - Cohort 4 (Gynecologic Cancers): Debio 1143 200 mg + Nivolumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   8/8 (100.00%)   8/8 (100.00%)   8/8 (100.00%)   8/8 (100.00%)   11/11 (100.00%) 
Blood and lymphatic system disorders             
Anaemia † 1  0/3 (0.00%)  3/8 (37.50%)  1/8 (12.50%)  2/8 (25.00%)  2/8 (25.00%)  4/11 (36.36%) 
Hyperleukocytosis † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/11 (0.00%) 
Lymph node pain † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Lymphadenopathy † 1  0/3 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Thrombocytopenia † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Cardiac disorders             
Angina pectoris † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/11 (0.00%) 
Atrial fibrillation † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/11 (0.00%) 
Ear and labyrinth disorders             
Hypoacusis † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/11 (0.00%) 
Endocrine disorders             
Hyperthyroidism † 1  0/3 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  1/11 (9.09%) 
Hypothyroidism † 1  0/3 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  1/11 (9.09%) 
Eye disorders             
Vision blurred † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/11 (0.00%) 
Gastrointestinal disorders             
Constipation † 1  0/3 (0.00%)  2/8 (25.00%)  2/8 (25.00%)  1/8 (12.50%)  1/8 (12.50%)  3/11 (27.27%) 
Diarrhoea † 1  0/3 (0.00%)  2/8 (25.00%)  3/8 (37.50%)  1/8 (12.50%)  0/8 (0.00%)  3/11 (27.27%) 
Dysphagia † 1  1/3 (33.33%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Gingival pain † 1  1/3 (33.33%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Nausea † 1  0/3 (0.00%)  2/8 (25.00%)  2/8 (25.00%)  2/8 (25.00%)  3/8 (37.50%)  2/11 (18.18%) 
Stomatitis † 1  1/3 (33.33%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  2/11 (18.18%) 
Vomiting † 1  0/3 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  1/8 (12.50%)  1/8 (12.50%)  0/11 (0.00%) 
Dry mouth † 1  0/3 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  2/11 (18.18%) 
Haemorrhoids † 1  0/3 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Oral pain † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
General disorders             
Asthenia † 1  0/3 (0.00%)  2/8 (25.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  2/11 (18.18%) 
Fatigue † 1  1/3 (33.33%)  1/8 (12.50%)  6/8 (75.00%)  3/8 (37.50%)  2/8 (25.00%)  2/11 (18.18%) 
Pyrexia † 1  0/3 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  3/11 (27.27%) 
Chills † 1  0/3 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Facial pain † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/11 (0.00%) 
Generalised oedema † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/11 (0.00%) 
Malaise † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/11 (0.00%) 
Hepatobiliary disorders             
Hepatic cytolysis † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Infections and infestations             
Ear Infection † 1  0/3 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Fungal Foot Infection † 1  0/3 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Lip Infection † 1  1/3 (33.33%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Mucosal infection † 1  1/3 (33.33%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Oral candidiasis † 1  0/3 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Upper respiratory tract infection † 1  1/3 (33.33%)  2/8 (25.00%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/11 (0.00%) 
Candida infection † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Gingivitis † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Listeria encephalitis † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Oral fungal infection † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Pseudomonas infection † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/11 (0.00%) 
Skin infection † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Soft tissue infection † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/11 (0.00%) 
Bronchitis † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/11 (0.00%) 
Urinary tract infection † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Injury, poisoning and procedural complications             
Subdural haematoma † 1  1/3 (33.33%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Craniocerebral injury † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/11 (0.00%) 
VIth nerve injury † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/11 (0.00%) 
Investigations             
Alanine aminotransferase increased † 1  0/3 (0.00%)  1/8 (12.50%)  2/8 (25.00%)  1/8 (12.50%)  1/8 (12.50%)  5/11 (45.45%) 
Amylase increased † 1  0/3 (0.00%)  2/8 (25.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  2/11 (18.18%) 
Aspartate aminotransferase increased † 1  0/3 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  1/8 (12.50%)  1/8 (12.50%)  4/11 (36.36%) 
Blood creatinine increased † 1  0/3 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Lipase increased † 1  0/3 (0.00%)  2/8 (25.00%)  2/8 (25.00%)  1/8 (12.50%)  0/8 (0.00%)  1/11 (9.09%) 
Weight decreased † 1  0/3 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  1/11 (9.09%) 
Blood alkaline phosphatase increased † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/11 (0.00%) 
Blood corticotrophin decreased † 1  0/3 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Blood creatine increased † 1  0/3 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%)  0/11 (0.00%) 
C-reactive protein increased † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/11 (0.00%) 
Cortisol decreased † 1  0/3 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Electrocardiogram QT prolonged † 1  0/3 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  1/11 (9.09%) 
Gamma-glutamyltransferase increased † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/11 (9.09%) 
Lymphocyte count decreased † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/11 (0.00%) 
Neutrophil count decreased † 1  0/3 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Metabolism and nutrition disorders             
Decreased appetite † 1  0/3 (0.00%)  1/8 (12.50%)  3/8 (37.50%)  3/8 (37.50%)  1/8 (12.50%)  1/11 (9.09%) 
Hypercalcaemia † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Hyperglycaemia † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Hypertriglyceridaemia † 1  0/3 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Hypokalaemia † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  2/11 (18.18%) 
Hypomagnesaemia † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  2/11 (18.18%) 
Hyponatraemia † 1  0/3 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  1/8 (12.50%)  3/11 (27.27%) 
Hypophosphataemia † 1  0/3 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Musculoskeletal and connective tissue disorders             
Back pain † 1  1/3 (33.33%)  1/8 (12.50%)  2/8 (25.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Musculoskeletal chest pain † 1  0/3 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Arthralgia † 1  0/3 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%)  1/11 (9.09%) 
Myalgia † 1  0/3 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%)  0/11 (0.00%) 
Pain in extremity † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Polymyalgia rheumatica † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Sacral pain † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/11 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Tumour pain † 1  0/3 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%)  0/11 (0.00%) 
Nervous system disorders             
Bell's palsy † 1  1/3 (33.33%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Dizziness † 1  1/3 (33.33%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Sciatica † 1  0/3 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/11 (0.00%) 
Dysgeusia † 1  0/3 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Headache † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/11 (0.00%) 
Memory impairment † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/11 (0.00%) 
Neuralgia † 1  0/3 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Somnolence † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  0/8 (0.00%)  0/11 (0.00%) 
Vocal cord paralysis † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Psychiatric disorders             
Agitation † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/11 (0.00%) 
Anxiety † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/11 (0.00%) 
Depression † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Insomnia † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/11 (9.09%) 
Renal and urinary disorders             
Dysuria † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Haematuria † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Renal failure † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  2/11 (18.18%) 
Urinary incontinence † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  2/11 (18.18%) 
Urinary retention † 1  0/3 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Reproductive system and breast disorders             
Intermenstrual bleeding † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Pelvic pain † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Vaginal fistula † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Vulvovaginal pruritus † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Respiratory, thoracic and mediastinal disorders             
Catarrh † 1  0/3 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Cough † 1  1/3 (33.33%)  1/8 (12.50%)  2/8 (25.00%)  1/8 (12.50%)  1/8 (12.50%)  1/11 (9.09%) 
Pneumonitis † 1  0/3 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Dyspnoea † 1  0/3 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%)  1/11 (9.09%) 
Hypoxia † 1  0/3 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Productive cough † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/11 (0.00%) 
Rhinitis allergic † 1  0/3 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Rhinorrhoea † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Throat irritation † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Skin and subcutaneous tissue disorders             
Dry skin † 1  1/3 (33.33%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Erythema † 1  0/3 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Leukoplakia † 1  1/3 (33.33%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Pruritus † 1  0/3 (0.00%)  3/8 (37.50%)  4/8 (50.00%)  2/8 (25.00%)  2/8 (25.00%)  3/11 (27.27%) 
Rash maculo-papular † 1  1/3 (33.33%)  0/8 (0.00%)  3/8 (37.50%)  0/8 (0.00%)  1/8 (12.50%)  1/11 (9.09%) 
Skin exfoliation † 1  0/3 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Dermatitis † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/11 (0.00%) 
Palmar-plantar erythrodysaesthesia syndrome † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Pemphigoid † 1  0/3 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/11 (0.00%) 
Rash † 1  0/3 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  1/8 (12.50%)  0/11 (0.00%) 
Rash macular † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  2/11 (18.18%) 
Skin lesion † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/11 (0.00%) 
Skin reaction † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
Urticaria † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/11 (9.09%) 
Vascular disorders             
Lymphoedema † 1  0/3 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/11 (9.09%) 
1
Term from vocabulary, MedDRA (24.0)
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Any publication or scientific communication related to this study can only take place once the agreement between the Sponsor and the Investigator has been reached.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Head Clinical Research & Development
Organization: Debiopharm International S.A.
Phone: 4121 321 01 11
EMail: info-international@debiopharm.com
Layout table for additonal information
Responsible Party: Debiopharm International SA
ClinicalTrials.gov Identifier: NCT04122625    
Other Study ID Numbers: Debio 1143-106
2018-003546-16 ( EudraCT Number )
First Submitted: August 30, 2019
First Posted: October 10, 2019
Results First Submitted: April 5, 2023
Results First Posted: June 12, 2023
Last Update Posted: June 12, 2023