The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Trial of Tisotumab Vedotin in Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03438396
Recruitment Status : Completed
First Posted : February 19, 2018
Results First Posted : November 4, 2021
Last Update Posted : July 25, 2023
Sponsor:
Collaborators:
Genmab
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Belgian Gynaecological Oncology Group
Gynecologic Oncology Group
Information provided by (Responsible Party):
Seagen Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cervical Cancer
Intervention Drug: tisotumab vedotin
Enrollment 102
Recruitment Details This study was conducted in Europe and the US.
Pre-assignment Details A 102 participants with Recurrent or Metastatic Cervical Cancer were enrolled in the study and out of which 101 participants received study treatment. These participants were assessed until the participant experienced IRC-verified disease progression, started new anti-cancer therapy, discontinued the trial, or died.
Arm/Group Title Tisotumab Vedotin
Hide Arm/Group Description Participants received IV tisotumab vedotin 2.0 mg/kg Q3W until radiographic disease progression verified by the IRC, unacceptable AEs requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.
Period Title: Overall Study
Started 102
Treated 101
Completed 0
Not Completed 102
Reason Not Completed
Reason Not Specified             9
Withdrawal by Subject             5
Lost to Follow-up             2
Death             85
Not treated             1
Arm/Group Title Tisotumab Vedotin
Hide Arm/Group Description Participants received IV tisotumab vedotin 2.0 mg/kg Q3W until radiographic disease progression verified by the IRC, unacceptable AEs requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.
Overall Number of Baseline Participants 101
Hide Baseline Analysis Population Description
Full analysis set (FAS) included all participants who received at least 1 dose of tisotumab vedotin.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants
50.66  (10.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants
Female
101
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants
Hispanic or Latino
6
   5.9%
Not Hispanic or Latino
95
  94.1%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   1.0%
White
95
  94.1%
More than one race
0
   0.0%
Unknown or Not Reported
3
   3.0%
1.Primary Outcome
Title Percentage of Participants With Confirmed Objective Response (OR) as Assessed by the Independent Review Committee (IRC)
Hide Description The confirmed OR is defined as best overall response of confirmed complete response (CR) or confirmed partial response (PR) based upon RECIST v1.1, assessed by the IRC. The CR is disappearance of all target and non-target lesions and no new lesions. A confirmed CR is 2 CRs (CR-CR sequence) that were separated by at least 4 weeks with no evidence of progression in-between. The PR is ≥ 30% decrease in the sum of diameters of target lesions (compared to baseline) and no unequivocal progression of existing non-target lesions and no new lesion. A confirmed PR is PR-PR sequence or PR-CR sequence that were separated by at least 4 weeks. The intermediate missing (Not Evaluable [NE]) scan evaluations between response scan and confirmation scan were allowed, eg, PR-NE-PR and PR-NE-NE-PR was considered PR confirmed (a repeat scan not earlier than 4 weeks after initial scan documenting response). 95% CI was calculated using the Clopper-Pearson method.
Time Frame From Day 1 through IRC verified disease progression, initiation of new anticancer therapy, study withdrawal, or death, whichever occurred first (approximately 20 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of tisotumab vedotin.
Arm/Group Title Tisotumab Vedotin
Hide Arm/Group Description:
Participants received IV tisotumab vedotin 2.0 mg/kg Q3W until radiographic disease progression verified by the IRC, unacceptable AEs requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.
Overall Number of Participants Analyzed 101
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
23.8
(15.9 to 33.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tisotumab Vedotin
Comments [Not Specified]
Type of Statistical Test Other
Comments The statistical hypotheses was tested to address ORR <= 11% vs. ORR > 11%.
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method one-sided exact test
Comments [Not Specified]
2.Secondary Outcome
Title Duration of Response (DOR) as Assessed by the IRC
Hide Description The DOR is defined as the duration from the first documented response of CR or PR (the start date of response, not the date when response was confirmed) to the date of the first documented progression disease (PD) verified by IRC or death. Based upon RECIST v1.1, the CR is defined as disappearance of all target and non-target lesions and no new lesions; the PR is defined as ≥ 30% decrease in the sum of diameters of target lesions (compared to baseline) and no unequivocal progression of existing non-target lesions and no new lesion; and the PD is defined as at least 20% increase in the sum of diameters of target lesions (compared to baseline), unequivocal progression of existing non-target lesions, and/or new lesion. The DOR was estimated using Kaplan-Meier method.
Time Frame From Day 1 through IRC verified disease progression, initiation of new anticancer therapy, study withdrawal, or death, whichever occurred first (approximately 49 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of tisotumab vedotin. The DOR was analyzed for those participants in FAS who achieved confirmed OR, as assessed by the IRC.
Arm/Group Title Tisotumab Vedotin
Hide Arm/Group Description:
Participants received IV tisotumab vedotin 2.0 mg/kg Q3W until radiographic disease progression verified by the IRC, unacceptable AEs requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.
Overall Number of Participants Analyzed 24
Median (95% Confidence Interval)
Unit of Measure: Months
8.3
(4.2 to 13.5)
3.Secondary Outcome
Title Percentage of Participants With Confirmed OR as Assessed by the Investigator
Hide Description The confirmed OR is defined as best overall response of confirmed CR or confirmed PR based upon RECIST v1.1, assessed by the investigator. The CR is defined as disappearance of all target and non-target lesions and no new lesions. A confirmed CR is defined as 2 CRs (CR-CR sequence) that were separated by at least 4 weeks with no evidence of progression in-between. The PR is defined as ≥ 30% decrease in the sum of diameters of target lesions (compared to baseline) and no unequivocal progression of existing non-target lesions and no new lesion. A confirmed PR is defined as PR-PR sequence or PR-CR sequence that were separated by at least 4 weeks. The intermediate missing (NE) scan evaluations between the response scan and the confirmation scan were allowed, eg, PR-NE-PR and PR-NE-NE-PR was considered PR confirmed (a repeat scan not earlier than 4 weeks after initial scan documenting response). 95% CI was calculated using the Clopper-Pearson method.
Time Frame From Day 1 through investigator verified disease progression, initiation of new anticancer therapy, study withdrawal, or death, whichever occurred first (approximately 49 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of tisotumab vedotin.
Arm/Group Title Tisotumab Vedotin
Hide Arm/Group Description:
Participants received IV tisotumab vedotin 2.0 mg/kg Q3W until radiographic disease progression verified by the IRC, unacceptable AEs requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.
Overall Number of Participants Analyzed 101
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
20.8
(13.4 to 30.0)
4.Secondary Outcome
Title DOR as Assessed by the Investigator
Hide Description The DOR is defined as the duration from the first documented response of CR or PR (the start date of response, not the date when response was confirmed) to the date of the first documented PD verified by investigator or death. Based upon RECIST v1.1, the CR is defined as disappearance of all target and non-target lesions and no new lesions; the PR is defined as ≥ 30% decrease in the sum of diameters of target lesions (compared to baseline) and no unequivocal progression of existing non-target lesions and no new lesion; and the PD is defined as at least 20% increase in the sum of diameters of target lesions (compared to baseline), unequivocal progression of existing non-target lesions, and/or new lesion. The DOR was estimated using Kaplan-Meier method.
Time Frame From Day 1 through investigator verified disease progression, initiation of new anticancer therapy, study withdrawal, or death, whichever occurred first (approximately 49 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of tisotumab vedotin. The DOR was analyzed for those participants in FAS who achieved confirmed OR, as assessed by the investigator.
Arm/Group Title Tisotumab Vedotin
Hide Arm/Group Description:
Participants received IV tisotumab vedotin 2.0 mg/kg Q3W until radiographic disease progression verified by the IRC, unacceptable AEs requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.
Overall Number of Participants Analyzed 21
Median (95% Confidence Interval)
Unit of Measure: Months
8.2
(3.7 to 18.4)
5.Secondary Outcome
Title Time to Response (TTR) as Assessed by the IRC
Hide Description The TTR is defined as the duration from the start of study drug to the first documented response of either CR or PR based on RECIST v1.1, assessed by the IRC. A confirmed CR is defined as 2 CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as 2 PRs (≥ 30% decrease in the sum of diameters of target lesions compared to baseline and no unequivocal progression of existing non-target lesions and no new lesion) or an un-confirmed PR and an un-confirmed CR or achieved PR-NE-PR or PR-NE-NE-PR that were separated by at least 4 weeks with no evidence of progression in-between.
Time Frame From Day 1 through IRC verified disease progression, initiation of new anticancer therapy, study withdrawal, or death, whichever occurred first (approximately 49 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of tisotumab vedotin. The TTR was analyzed for those participants in FAS who achieved confirmed OR, as assessed by the IRC.
Arm/Group Title Tisotumab Vedotin
Hide Arm/Group Description:
Participants received IV tisotumab vedotin 2.0 mg/kg Q3W until radiographic disease progression verified by the IRC, unacceptable AEs requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.
Overall Number of Participants Analyzed 24
Median (Full Range)
Unit of Measure: Months
1.4
(1.1 to 5.1)
6.Secondary Outcome
Title TTR as Assessed by the Investigator
Hide Description The TTR is defined as the duration from the start of study drug to the first documented response of either CR or PR based on RECIST v1.1, assessed by the investigator. A confirmed CR is defined as 2 CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as 2 PRs (≥ 30% decrease in the sum of diameters of target lesions compared to baseline and no unequivocal progression of existing non-target lesions and no new lesion) or an un-confirmed PR and an un-confirmed CR or achieved PR-NE-PR or PR-NE-NE-PR that were separated by at least 4 weeks with no evidence of progression in-between.
Time Frame From Day 1 through investigator verified disease progression, initiation of new anticancer therapy, study withdrawal, or death, whichever occurred first (approximately 49 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of tisotumab vedotin. The TTR was analyzed for those participants in FAS who achieved confirmed OR, as assessed by the investigator.
Arm/Group Title Tisotumab Vedotin
Hide Arm/Group Description:
Participants received IV tisotumab vedotin 2.0 mg/kg Q3W until radiographic disease progression verified by the IRC, unacceptable AEs requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.
Overall Number of Participants Analyzed 21
Median (Full Range)
Unit of Measure: Months
1.4
(1.1 to 4.5)
7.Secondary Outcome
Title Progression Free Survival (PFS) as Assessed by the IRC
Hide Description The PFS is defined as the time from the start of study drug until the first documentation of PD based on RECIST v1.1, as assessed by the IRC or death due to any cause, whichever occurred first. The PD based upon RECIST v1.1 is defined as at least 20% increase in the sum of diameters of target lesions (compared to baseline), unequivocal progression of existing non-target lesions, and/or new lesion. The PFS was estimated using Kaplan-Meier method.
Time Frame From Day 1 through IRC verified disease progression, initiation of new anticancer therapy, study withdrawal, or death, whichever occurred first (approximately 49 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of tisotumab vedotin.
Arm/Group Title Tisotumab Vedotin
Hide Arm/Group Description:
Participants received IV tisotumab vedotin 2.0 mg/kg Q3W until radiographic disease progression verified by the IRC, unacceptable AEs requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.
Overall Number of Participants Analyzed 101
Median (95% Confidence Interval)
Unit of Measure: Months
4.2
(3.0 to 4.4)
8.Secondary Outcome
Title PFS as Assessed by the Investigator
Hide Description The PFS is defined as the time from the start of study drug until the first documentation of PD based on RECIST v1.1, as assessed by the investigator or death due to any cause, whichever occurred first. The PD based upon RECIST v1.1 is defined as at least 20% increase in the sum of diameters of target lesions (compared to baseline), unequivocal progression of existing non-target lesions, and/or new lesion. The PFS was estimated using Kaplan-Meier method.
Time Frame From Day 1 through investigator verified disease progression, initiation of new anticancer therapy, study withdrawal, or death, whichever occurred first (approximately 49 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of tisotumab vedotin.
Arm/Group Title Tisotumab Vedotin
Hide Arm/Group Description:
Participants received IV tisotumab vedotin 2.0 mg/kg Q3W until radiographic disease progression verified by the IRC, unacceptable AEs requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.
Overall Number of Participants Analyzed 101
Median (95% Confidence Interval)
Unit of Measure: Months
4.1
(3.3 to 4.6)
9.Secondary Outcome
Title Overall Survival (OS)
Hide Description The OS is defined as the time from the start of study treatment until death due to any cause. The OS was estimated using Kaplan-Meier method.
Time Frame From Day 1 until death or withdrawal from the study, whichever occurred first (approximately 49 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of tisotumab vedotin.
Arm/Group Title Tisotumab Vedotin
Hide Arm/Group Description:
Participants received IV tisotumab vedotin 2.0 mg/kg Q3W until radiographic disease progression verified by the IRC, unacceptable AEs requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.
Overall Number of Participants Analyzed 101
Median (95% Confidence Interval)
Unit of Measure: Months
12.3
(9.6 to 14.1)
10.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Hide Description An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE is defined as an AE that meets one of the following criteria: fatal or life-threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; medically significant (an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above [medical and scientific judgment must be exercised in deciding whether an AE is "medically important"]); required inpatient hospitalization or prolongation of existing hospitalization. A TEAE is defined as an AE occurring or worsening between the first dose of tisotumab vedotin and 30 days after the last dose received.
Time Frame From Day 1 through 30 days after the last dose of study drug (approximately 49 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of tisotumab vedotin.
Arm/Group Title Tisotumab Vedotin
Hide Arm/Group Description:
Participants received IV tisotumab vedotin 2.0 mg/kg Q3W until radiographic disease progression verified by the IRC, unacceptable AEs requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.
Overall Number of Participants Analyzed 101
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
101
 100.0%
Any TESAE
44
  43.6%
11.Secondary Outcome
Title Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs
Hide Description Laboratory abnormalities that induced clinical signs or symptoms, required concomitant therapy or required changes during treatment emergent period were reported as TEAEs. Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported.
Time Frame From Day 1 through 30 days after the last dose of study drug (approximately 49 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of tisotumab vedotin.
Arm/Group Title Tisotumab Vedotin
Hide Arm/Group Description:
Participants received IV tisotumab vedotin 2.0 mg/kg Q3W until radiographic disease progression verified by the IRC, unacceptable AEs requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.
Overall Number of Participants Analyzed 101
Measure Type: Count of Participants
Unit of Measure: Participants
Anaemia
34
  33.7%
Neutropenia
4
   4.0%
Iron deficiency anaemia
3
   3.0%
Leukocytosis
1
   1.0%
Leukopenia
1
   1.0%
Thrombocytopenia
1
   1.0%
Thrombocytosis
1
   1.0%
Hypokalaemia
6
   5.9%
Hypomagnesaemia
6
   5.9%
Hypocalcaemia
4
   4.0%
Hyperglycaemia
3
   3.0%
Hypercreatininaemia
2
   2.0%
Hyperuricaemia
2
   2.0%
Hypercalcaemia
1
   1.0%
Hypernatraemia
1
   1.0%
Hypoalbuminaemia
1
   1.0%
Hyponatraemia
1
   1.0%
Activated partial thromboplastin time prolonged
3
   3.0%
Neutrophil count decreased
3
   3.0%
Blood creatinine increased
2
   2.0%
C-reactive protein increased
2
   2.0%
International normalised ratio increased
2
   2.0%
Lymphocyte count decreased
2
   2.0%
Alanine aminotransferase increased
1
   1.0%
Aspartate aminotransferase increased
1
   1.0%
Blood alkaline phosphatase increased
1
   1.0%
Blood bicarbonate decreased
1
   1.0%
Blood creatine phosphokinase increased
2
   2.0%
Blood potassium decreased
1
   1.0%
Creatinine renal clearance decreased
1
   1.0%
Platelet count decreased
2
   2.0%
Prothrombin time prolonged
1
   1.0%
White blood cell count decreased
1
   1.0%
Hyperthyroidism
1
   1.0%
Hypothyroidism
1
   1.0%
Hypertransaminasaemia
3
   3.0%
Hyperbilirubinaemia
1
   1.0%
Haematuria
10
   9.9%
12.Secondary Outcome
Title Plasma Concentrations of Tisotumab Vedotin (HuMax-TF), Tisotumab Vedotin Antibody-drug Conjugate (HuMax-TF-ADC), and Free Monomethyl Auristatin E (MMAE)
Hide Description Plasma concentrations of HuMax-TF, HuMax-TF-ADC, and Free MMAE measures on Cycle 1 Day 1 (predose and end of infusion) and Cycle 6 Day 1 (predose and end of infusion) are reported.
Time Frame Predose and end of infusion of Cycle 1 Day 1 (C1D1) and Cycle 6 Day 1 (C6D1)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 dose of tisotumab vedotin.
Arm/Group Title Tisotumab Vedotin
Hide Arm/Group Description:
Participants received IV tisotumab vedotin 2.0 mg/kg Q3W until radiographic disease progression verified by the IRC, unacceptable AEs requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.
Overall Number of Participants Analyzed 101
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
HuMax-TF (C1D1-predose) Number Analyzed 98 participants
163.48
(60.70%)
HuMax-TF (C1D1-end of infusion) Number Analyzed 98 participants
41691.0
(68.02%)
HuMax-TF (C6D1-predose) Number Analyzed 54 participants
150.0
(0.0%)
HuMax-TF (C6D1-end of infusion) Number Analyzed 54 participants
36941
(25.88%)
HuMax-TF-ADC (C1D1-predose) Number Analyzed 97 participants
30.0
(0.0%)
HuMax-TF-ADC (C1D1-end of infusion) Number Analyzed 97 participants
38105
(92.62%)
HuMax-TF-ADC (C6D1-predose) Number Analyzed 54 participants
30.0
(0.0%)
HuMax-TF-ADC (C6D1-end of infusion) Number Analyzed 53 participants
36270.0
(28.29%)
MMAE (C1D1-predose) Number Analyzed 96 participants
12.50
(0.0%)
MMAE (C1D1-end of infusion) Number Analyzed 97 participants
171.27
(102.05%)
MMAE (C6D1-predose) Number Analyzed 53 participants
46.71
(146.11%)
MMAE (C6D1-end of infusion) Number Analyzed 54 participants
177.46
(82.62%)
13.Secondary Outcome
Title Number of Participants With Positive Anti-drug Antibodies (ADA) to Tisotumab Vedotin
Hide Description Number of participants with positive ADA titer to tisotumab vedotin at baseline and post-baseline are reported. Baseline is defined as the latest available measurement made before the first dose of tisotumab vedotin. For post-baseline results, a participant was considered ADA positive if either ADA is negative at baseline and at least one post-baseline result is positive or positive at baseline and at least one positive post-baseline result with a titer higher than baseline.
Time Frame Predose of each treatment cycle (Cycle 1 to 21) and end of treatment visit (approximately 49 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in FAS (received at least 1 dose of tisotumab vedotin) and who had ADA results at baseline and post-baseline are analyzed for this outcome measure.
Arm/Group Title Tisotumab Vedotin
Hide Arm/Group Description:
Participants received IV tisotumab vedotin 2.0 mg/kg Q3W until radiographic disease progression verified by the IRC, unacceptable AEs requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.
Overall Number of Participants Analyzed 93
Measure Type: Count of Participants
Unit of Measure: Participants
ADA positive at Baseline
2
   2.2%
ADA positive at post-baseline
5
   5.4%
Time Frame From Day 1 through 30 days after the last dose of study drug (approximately 49 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tisotumab Vedotin
Hide Arm/Group Description Participants received IV tisotumab vedotin 2.0 mg/kg Q3W until radiographic disease progression verified by the IRC, unacceptable AEs requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.
All-Cause Mortality
Tisotumab Vedotin
Affected / at Risk (%)
Total   86/101 (85.15%)    
Hide Serious Adverse Events
Tisotumab Vedotin
Affected / at Risk (%) # Events
Total   44/101 (43.56%)    
Blood and lymphatic system disorders   
Anaemia † 1  2/101 (1.98%)  2
Eye disorders   
Ulcerative Keratitis † 1  1/101 (0.99%)  1
Gastrointestinal disorders   
Constipation † 1  3/101 (2.97%)  3
Ileus † 1  2/101 (1.98%)  3
Abdominal pain † 1  1/101 (0.99%)  1
Intestinal obstruction † 1  1/101 (0.99%)  1
Large intestinal obstruction † 1  1/101 (0.99%)  1
Rectal haemorrhage † 1  1/101 (0.99%)  1
Subileus † 1  1/101 (0.99%)  1
Vomiting † 1  1/101 (0.99%)  1
General disorders   
Pyrexia † 1  3/101 (2.97%)  3
Death † 1  2/101 (1.98%)  2
Asthenia † 1  1/101 (0.99%)  1
Infusion site extravasation † 1  1/101 (0.99%)  1
Non-cardiac chest pain † 1  1/101 (0.99%)  1
Pain † 1  1/101 (0.99%)  2
Infections and infestations   
Pneumonia † 1  4/101 (3.96%)  4
Septic shock † 1  2/101 (1.98%)  2
Urinary tract infection † 1  3/101 (2.97%)  3
Cellulitis † 1  1/101 (0.99%)  1
Infection † 1  1/101 (0.99%)  1
Lower respiratory tract infection † 1  1/101 (0.99%)  1
Neutropenic sepsis † 1  1/101 (0.99%)  1
Respiratory tract infection † 1  1/101 (0.99%)  1
Urosepsis † 1  1/101 (0.99%)  1
Injury, poisoning and procedural complications   
Foot fracture † 1  1/101 (0.99%)  1
Post-traumatic pain † 1  1/101 (0.99%)  1
Thoracic vertebral fracture † 1  1/101 (0.99%)  1
Investigations   
General physical condition abnormal † 1  1/101 (0.99%)  1
Musculoskeletal and connective tissue disorders   
Back pain † 1  1/101 (0.99%)  1
Fistula discharge † 1  1/101 (0.99%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bladder cancer † 1  1/101 (0.99%)  1
Cancer pain † 1  1/101 (0.99%)  1
Nervous system disorders   
Peripheral sensorimotor neuropathy † 1  2/101 (1.98%)  2
Peripheral motor neuropathy † 1  1/101 (0.99%)  1
Renal and urinary disorders   
Urinary tract obstruction † 1  2/101 (1.98%)  2
Acute kidney injury † 1  1/101 (0.99%)  2
Cystitis haemorrhagic † 1  1/101 (0.99%)  1
Haematuria † 1  1/101 (0.99%)  1
Renal failure † 1  1/101 (0.99%)  1
Reproductive system and breast disorders   
Vaginal haemorrhage † 1  2/101 (1.98%)  2
Respiratory, thoracic and mediastinal disorders   
Pneumonitis † 1  2/101 (1.98%)  2
Dyspnoea † 1  1/101 (0.99%)  1
Pleural effusion † 1  1/101 (0.99%)  1
Pulmonary embolism † 1  1/101 (0.99%)  1
Vascular disorders   
Lymphoedema † 1  1/101 (0.99%)  1
1
Term from vocabulary, MedDRA version 22.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tisotumab Vedotin
Affected / at Risk (%) # Events
Total   99/101 (98.02%)    
Blood and lymphatic system disorders   
Anaemia † 1  33/101 (32.67%)  39
Neutropenia † 1  4/101 (3.96%)  5
Leukopenia † 1  1/101 (0.99%)  1
Leukocytosis † 1  1/101 (0.99%)  1
Iron deficiency anaemia † 1  3/101 (2.97%)  3
Thrombocytosis † 1  1/101 (0.99%)  1
Thrombocytopenia † 1  1/101 (0.99%)  1
Cardiac disorders   
Stress cardiomyopathy † 1  1/101 (0.99%)  1
Sinus tachycardia † 1  2/101 (1.98%)  2
Myocardial infarction † 1  1/101 (0.99%)  1
Ear and labyrinth disorders   
Vertigo † 1  2/101 (1.98%)  2
Tinnitus † 1  1/101 (0.99%)  1
Endocrine disorders   
Hypothyroidism † 1  2/101 (1.98%)  2
Hyperthyroidism † 1  1/101 (0.99%)  1
Eye disorders   
Dry eye † 1  25/101 (24.75%)  30
Keratitis † 1  11/101 (10.89%)  15
Blepharitis † 1  7/101 (6.93%)  10
Punctate keratitis † 1  6/101 (5.94%)  6
Amblyopia † 1  1/101 (0.99%)  1
Asthenopia † 1  1/101 (0.99%)  1
Blepharospasm † 1  1/101 (0.99%)  1
Cataract † 1  2/101 (1.98%)  2
Chalazion † 1  1/101 (0.99%)  1
Conjunctival erosion † 1  1/101 (0.99%)  1
Conjunctival haemorrhage † 1  2/101 (1.98%)  3
Vision blurred † 1  3/101 (2.97%)  3
Ulcerative keratitis † 1  4/101 (3.96%)  4
Trichiasis † 1  2/101 (1.98%)  2
Retinal exudates † 1  1/101 (0.99%)  1
Photophobia † 1  1/101 (0.99%)  1
Ocular hypertension † 1  1/101 (0.99%)  1
Ocular hyperaemia † 1  4/101 (3.96%)  4
Noninfective conjunctivitis † 1  1/101 (0.99%)  1
Meibomianitis † 1  3/101 (2.97%)  3
Meibomian gland dysfunction † 1  1/101 (0.99%)  1
Lacrimation increased † 1  4/101 (3.96%)  4
Keratopathy † 1  1/101 (0.99%)  1
Foreign body sensation in eyes † 1  1/101 (0.99%)  1
Eye pruritus † 1  1/101 (0.99%)  1
Eye pain † 1  1/101 (0.99%)  1
Eye movement disorder † 1  1/101 (0.99%)  1
Eye irritation † 1  1/101 (0.99%)  1
Eye inflammation † 1  1/101 (0.99%)  1
Eye discharge † 1  3/101 (2.97%)  3
Entropion † 1  3/101 (2.97%)  3
Corneal scar † 1  1/101 (0.99%)  1
Corneal erosion † 1  2/101 (1.98%)  2
Corneal bleeding † 1  1/101 (0.99%)  1
Conjunctival hyperaemia † 1  2/101 (1.98%)  2
Gastrointestinal disorders   
Nausea † 1  41/101 (40.59%)  51
Diarrhoea † 1  25/101 (24.75%)  29
Constipation † 1  20/101 (19.80%)  20
Vomiting † 1  17/101 (16.83%)  25
Abdominal pain † 1  13/101 (12.87%)  18
Dry mouth † 1  8/101 (7.92%)  8
Abdominal pain upper † 1  6/101 (5.94%)  6
Abdominal discomfort † 1  1/101 (0.99%)  1
Abdominal distension † 1  2/101 (1.98%)  2
Abdominal pain lower † 1  1/101 (0.99%)  1
Anal haemorrhage † 1  1/101 (0.99%)  2
Anal incontinence † 1  1/101 (0.99%)  1
Colitis † 1  1/101 (0.99%)  1
Duodenogastric reflux † 1  1/101 (0.99%)  1
Dyschezia † 1  1/101 (0.99%)  1
Dyspepsia † 1  3/101 (2.97%)  3
Enteritis † 1  1/101 (0.99%)  1
Flatulence † 1  1/101 (0.99%)  1
Gastritis † 1  2/101 (1.98%)  2
Gastrooesophageal reflux disease † 1  1/101 (0.99%)  1
Gingival bleeding † 1  2/101 (1.98%)  2
Haematochezia † 1  2/101 (1.98%)  2
Haemorrhoids † 1  2/101 (1.98%)  2
Hiatus hernia † 1  1/101 (0.99%)  1
Large intestinal haemorrhage † 1  1/101 (0.99%)  1
Lower gastrointestinal haemorrhage † 1  1/101 (0.99%)  1
Mouth ulceration † 1  1/101 (0.99%)  1
Oesophagitis † 1  1/101 (0.99%)  1
Rectal haemorrhage † 1  3/101 (2.97%)  3
Retching † 1  1/101 (0.99%)  1
Small intestinal stenosis † 1  1/101 (0.99%)  1
Stomatitis † 1  3/101 (2.97%)  4
Subileus † 1  1/101 (0.99%)  1
General disorders   
Fatigue † 1  35/101 (34.65%)  47
Asthenia † 1  18/101 (17.82%)  18
Pyrexia † 1  15/101 (14.85%)  38
Influenza like illness † 1  7/101 (6.93%)  7
Oedema peripheral † 1  8/101 (7.92%)  9
Face oedema † 1  1/101 (0.99%)  1
Chest discomfort † 1  1/101 (0.99%)  1
Chest pain † 1  1/101 (0.99%)  1
Chills † 1  3/101 (2.97%)  4
Facial pain † 1  1/101 (0.99%)  1
Gait disturbance † 1  1/101 (0.99%)  1
Infusion site coldness † 1  1/101 (0.99%)  1
Localised oedema † 1  1/101 (0.99%)  1
Malaise † 1  1/101 (0.99%)  1
Mucosal disorder † 1  1/101 (0.99%)  1
Mucosal inflammation † 1  1/101 (0.99%)  1
Nodule † 1  1/101 (0.99%)  1
Non-cardiac chest pain † 1  1/101 (0.99%)  1
Oedema † 1  1/101 (0.99%)  1
Pain † 1  3/101 (2.97%)  3
Peripheral swelling † 1  1/101 (0.99%)  1
Thirst † 1  1/101 (0.99%)  1
Hepatobiliary disorders   
Hypertransaminasaemia † 1  3/101 (2.97%)  3
Hyperbilirubinaemia † 1  1/101 (0.99%)  1
Immune system disorders   
Allergy to metals † 1  1/101 (0.99%)  1
Infections and infestations   
Conjunctivitis † 1  31/101 (30.69%)  49
Urinary tract infection † 1  10/101 (9.90%)  12
Nasopharyngitis † 1  7/101 (6.93%)  7
Abscess limb † 1  1/101 (0.99%)  1
Bronchitis † 1  1/101 (0.99%)  1
Catheter site infection † 1  1/101 (0.99%)  1
Clostridium difficile colitis † 1  1/101 (0.99%)  1
Corona virus infection † 1  1/101 (0.99%)  1
Cystitis † 1  3/101 (2.97%)  3
Device related infection † 1  1/101 (0.99%)  1
Diverticulitis † 1  1/101 (0.99%)  1
Folliculitis † 1  1/101 (0.99%)  1
Gastroenteritis † 1  1/101 (0.99%)  1
Genital herpes † 1  1/101 (0.99%)  1
Gingivitis † 1  1/101 (0.99%)  1
Herpes ophthalmic † 1  1/101 (0.99%)  1
Herpes zoster † 1  1/101 (0.99%)  1
Herpes zoster oticus † 1  1/101 (0.99%)  2
Parotitis † 1  1/101 (0.99%)  1
Pharyngitis streptococcal † 1  1/101 (0.99%)  1
Respiratory tract infection † 1  1/101 (0.99%)  1
Rhinitis † 1  3/101 (2.97%)  3
Stenotrophomonas infection † 1  1/101 (0.99%)  1
Tooth abscess † 1  1/101 (0.99%)  1
Upper respiratory tract infection † 1  6/101 (5.94%)  6
Urinary tract infection bacterial † 1  1/101 (0.99%)  1
Vaginal infection † 1  2/101 (1.98%)  2
Injury, poisoning and procedural complications   
Urinary tract stoma complication † 1  1/101 (0.99%)  1
Thermal burn † 1  1/101 (0.99%)  2
Spinal compression fracture † 1  1/101 (0.99%)  1
Radiation proctitis † 1  1/101 (0.99%)  1
Radiation associated haemorrhage † 1  1/101 (0.99%)  1
Procedural pain † 1  1/101 (0.99%)  1
Post procedural haemorrhage † 1  1/101 (0.99%)  1
Ligament sprain † 1  1/101 (0.99%)  1
Foot fracture † 1  1/101 (0.99%)  1
Contusion † 1  2/101 (1.98%)  2
Conjunctival scar † 1  1/101 (0.99%)  1
Conjunctival abrasion † 1  1/101 (0.99%)  1
Investigations   
Weight decreased † 1  14/101 (13.86%)  14
Weight increased † 1  1/101 (0.99%)  1
Prothrombin time prolonged † 1  1/101 (0.99%)  1
Platelet count decreased † 1  2/101 (1.98%)  2
Neutrophil count decreased † 1  3/101 (2.97%)  3
Lymphocyte count decreased † 1  2/101 (1.98%)  2
International normalised ratio increased † 1  2/101 (1.98%)  2
Electrocardiogram QT prolonged † 1  2/101 (1.98%)  2
Ejection fraction decreased † 1  1/101 (0.99%)  1
C-reactive protein increased † 1  1/101 (0.99%)  1
Blood potassium decreased † 1  1/101 (0.99%)  1
Blood creatinine increased † 1  2/101 (1.98%)  2
Blood creatine phosphokinase increased † 1  2/101 (1.98%)  2
Blood bicarbonate decreased † 1  1/101 (0.99%)  1
Blood alkaline phosphatase increased † 1  1/101 (0.99%)  1
Aspartate aminotransferase increased † 1  1/101 (0.99%)  1
Alanine aminotransferase increased † 1  1/101 (0.99%)  1
Activated partial thromboplastin time prolonged † 1  3/101 (2.97%)  3
White blood cell count decreased † 1  1/101 (0.99%)  1
Creatinine renal clearance decreased † 1  1/101 (0.99%)  1
Metabolism and nutrition disorders   
Decreased appetite † 1  18/101 (17.82%)  19
Hypokalaemia † 1  6/101 (5.94%)  6
Hypomagnesaemia † 1  6/101 (5.94%)  6
Hyponatraemia † 1  1/101 (0.99%)  1
Hypocalcaemia † 1  4/101 (3.96%)  5
Hypoalbuminaemia † 1  1/101 (0.99%)  1
Hyperuricaemia † 1  2/101 (1.98%)  2
Hypernatraemia † 1  1/101 (0.99%)  1
Hyperglycaemia † 1  3/101 (2.97%)  3
Hypercreatininaemia † 1  2/101 (1.98%)  3
Hypercalcaemia † 1  1/101 (0.99%)  1
Diabetes mellitus † 1  1/101 (0.99%)  1
Dehydration † 1  4/101 (3.96%)  5
Musculoskeletal and connective tissue disorders   
Arthralgia † 1  17/101 (16.83%)  25
Myalgia † 1  17/101 (16.83%)  26
Pain in extremity † 1  13/101 (12.87%)  13
Back pain † 1  8/101 (7.92%)  8
Bone pain † 1  5/101 (4.95%)  6
Musculoskeletal pain † 1  7/101 (6.93%)  7
Flank pain † 1  3/101 (2.97%)  5
Groin pain † 1  1/101 (0.99%)  1
Hypercreatinaemia † 1  1/101 (0.99%)  1
Joint stiffness † 1  1/101 (0.99%)  1
Limb discomfort † 1  2/101 (1.98%)  2
Muscle spasms † 1  4/101 (3.96%)  4
Muscular weakness † 1  2/101 (1.98%)  2
Musculoskeletal chest pain † 1  1/101 (0.99%)  1
Musculoskeletal discomfort † 1  1/101 (0.99%)  1
Neck pain † 1  1/101 (0.99%)  1
Osteoarthritis † 1  1/101 (0.99%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Acoustic neuroma † 1  1/101 (0.99%)  1
Cancer pain † 1  1/101 (0.99%)  1
Tumour pain † 1  1/101 (0.99%)  1
Nervous system disorders   
Neuropathy peripheral † 1  3/101 (2.97%)  3
Peripheral sensory neuropathy † 1  19/101 (18.81%)  24
Headache † 1  8/101 (7.92%)  12
Sensory loss † 1  1/101 (0.99%)  1
Sciatica † 1  1/101 (0.99%)  1
Polyneuropathy † 1  2/101 (1.98%)  2
Peripheral sensorimotor neuropathy † 1  4/101 (3.96%)  4
Peripheral motor neuropathy † 1  3/101 (2.97%)  3
Paraesthesia † 1  4/101 (3.96%)  6
Neuralgia † 1  2/101 (1.98%)  3
Hypoaesthesia † 1  3/101 (2.97%)  4
Hyperaesthesia † 1  1/101 (0.99%)  1
Dysgeusia † 1  4/101 (3.96%)  4
Dizziness † 1  4/101 (3.96%)  4
Burning sensation † 1  4/101 (3.96%)  4
Psychiatric disorders   
Insomnia † 1  10/101 (9.90%)  10
Anxiety † 1  5/101 (4.95%)  5
Depression † 1  4/101 (3.96%)  4
Depressed mood † 1  1/101 (0.99%)  1
Renal and urinary disorders   
Haematuria † 1  9/101 (8.91%)  11
Urinary tract obstruction † 1  1/101 (0.99%)  1
Urinary tract disorder † 1  1/101 (0.99%)  1
Urinary incontinence † 1  2/101 (1.98%)  2
Urinary bladder haemorrhage † 1  1/101 (0.99%)  1
Ureteric obstruction † 1  1/101 (0.99%)  1
Renal failure † 1  2/101 (1.98%)  2
Hydronephrosis † 1  1/101 (0.99%)  1
Dysuria † 1  5/101 (4.95%)  6
Chromaturia † 1  1/101 (0.99%)  1
Bladder outlet obstruction † 1  1/101 (0.99%)  1
Reproductive system and breast disorders   
Vaginal haemorrhage † 1  10/101 (9.90%)  13
Vulvovaginal pain † 1  1/101 (0.99%)  1
Vaginal ulceration † 1  1/101 (0.99%)  1
Vaginal fistula † 1  1/101 (0.99%)  1
Vaginal discharge † 1  4/101 (3.96%)  5
Rectocele † 1  1/101 (0.99%)  1
Pelvic pain † 1  3/101 (2.97%)  3
Metrorrhagia † 1  1/101 (0.99%)  1
Genital swelling † 1  1/101 (0.99%)  1
Genital prolapse † 1  1/101 (0.99%)  1
Cystocele † 1  1/101 (0.99%)  1
Respiratory, thoracic and mediastinal disorders   
Epistaxis † 1  39/101 (38.61%)  49
Cough † 1  9/101 (8.91%)  9
Rhinorrhoea † 1  6/101 (5.94%)  6
Nasal obstruction † 1  1/101 (0.99%)  1
Nasal dryness † 1  4/101 (3.96%)  4
Nasal congestion † 1  3/101 (2.97%)  3
Haemoptysis † 1  1/101 (0.99%)  1
Dyspnoea † 1  5/101 (4.95%)  6
Dysphonia † 1  2/101 (1.98%)  2
Sneezing † 1  1/101 (0.99%)  1
Sinus congestion † 1  2/101 (1.98%)  2
Pulmonary oedema † 1  1/101 (0.99%)  1
Pulmonary embolism † 1  2/101 (1.98%)  2
Paranasal sinus discomfort † 1  1/101 (0.99%)  1
Oropharyngeal pain † 1  3/101 (2.97%)  3
Paranasal sinus haemorrhage † 1  1/101 (0.99%)  1
Skin and subcutaneous tissue disorders   
Alopecia † 1  39/101 (38.61%)  39
Pruritus † 1  14/101 (13.86%)  18
Rash † 1  14/101 (13.86%)  16
Rash maculo-papular † 1  6/101 (5.94%)  6
Dermatitis acneiform † 1  1/101 (0.99%)  1
Dermatitis allergic † 1  1/101 (0.99%)  1
Dry skin † 1  3/101 (2.97%)  3
Eczema † 1  1/101 (0.99%)  1
Erythema † 1  5/101 (4.95%)  5
Hyperhidrosis † 1  3/101 (2.97%)  4
Pain of skin † 1  1/101 (0.99%)  2
Rash macular † 1  1/101 (0.99%)  1
Skin discolouration † 1  1/101 (0.99%)  1
Skin hyperpigmentation † 1  1/101 (0.99%)  1
Vascular disorders   
Hot flush † 1  5/101 (4.95%)  6
Deep vein thrombosis † 1  1/101 (0.99%)  1
Aortic thrombosis † 1  1/101 (0.99%)  1
Hypertension † 1  2/101 (1.98%)  2
Venous thrombosis limb † 1  3/101 (2.97%)  3
Thrombosis † 1  1/101 (0.99%)  1
Lymphoedema † 1  3/101 (2.97%)  3
Hypotension † 1  1/101 (0.99%)  1
1
Term from vocabulary, MedDRA version 22.1
†
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.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is at least 12 months but less than 18 months from the end of study (database lock). The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ibrahima Soumaoro
Organization: Genmab A/S
Phone: +1 609 430 2481
EMail: clinicaltrials@genmab.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT03438396    
Other Study ID Numbers: GCT1015-04
innovaTV 204 ( Other Identifier: Genmab )
First Submitted: February 8, 2018
First Posted: February 19, 2018
Results First Submitted: October 6, 2021
Results First Posted: November 4, 2021
Last Update Posted: July 25, 2023