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Troriluzole or Placebo Plus Ipi Plus Nivo in Mel Brain Mets

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ClinicalTrials.gov Identifier: NCT04899921
Recruitment Status : Terminated (Due to poor enrollment)
First Posted : May 25, 2021
Results First Posted : December 13, 2023
Last Update Posted : March 26, 2024
Sponsor:
Collaborator:
Biohaven Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Ann W. Silk, MD MS, Dana-Farber Cancer Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Melanoma
Metastatic Melanoma
Interventions Drug: Ipilimumab
Drug: Nivolumab
Drug: Troriluzole
Drug: Placebo
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 1] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 2] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 3]
Hide Arm/Group Description Phase I dose level 1 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and the original starting troriluzole dose of 140 mg orally in the morning as well as 280 mg orally in the evening every day of each 21-day cycle. Participants were treated until disease progression or unacceptable toxicity. Phase I dose level 2 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg twice per day orally. Participants were treated until disease progression or unacceptable toxicity, Phase I dose level 3 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg/day orally. Participants were treated until disease progression or unacceptable toxicity
Period Title: Overall Study
Started 0 0 0
Completed [1] 0 0 0
Not Completed 0 0 0
[1]
Terminated with 1 patient enrolled, no data due to patient privacy.
Arm/Group Title Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 1] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 2] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 3] Total
Hide Arm/Group Description Phase I dose level 1 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and the original starting troriluzole dose of 140 mg orally in the morning as well as 280 mg orally in the evening every day of each 21-day cycle. Participants were treated until disease progression or unacceptable toxicity. Phase I dose level 2 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg twice per day orally. Participants were treated until disease progression or unacceptable toxicity. Phase I dose level 3 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg/day orally. Participants were treated until disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 0 0 0 0
Hide Baseline Analysis Population Description
Terminated with1 patient enrolled; no data due to patient privacy.
Age, Categorical  
Number Analyzed 0 participants 0 participants 0 participants 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Age, Continuous   [1] 
Unit of measure:  Years
 Number Analyzed 0 participants 0 participants 0 participants 0 participants
[1]
Measure Description: years
Sex: Female, Male  
Number Analyzed 0 participants 0 participants 0 participants 0 participants
Female
Male
Ethnicity (NIH/OMB)  
Number Analyzed 0 participants 0 participants 0 participants 0 participants
Hispanic or Latino
Not Hispanic or Latino
Unknown or Not Reported
Race (NIH/OMB)  
Number Analyzed 0 participants 0 participants 0 participants 0 participants
American Indian or Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More than one race
Unknown or Not Reported
Region of Enrollment  
Unit of measure:  Participants
United States Number Analyzed 0 participants 0 participants 0 participants 0 participants
1.Primary Outcome
Title Median Global Progression-Free Survival (PFS)
Hide Description Global PFS is defined as the time from random assignment to the earlier of death or documented disease progression in the intracranial or extracranial compartments. The follow-up of patients who have neither died nor progressed will be censored at the date of the last follow-up visit. Disease assessment was based on RECIST 1.1 for all extracranial lesions and modified RECIST 1.1 for all brain lesions. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated,
Time Frame Participants would be followed up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Terminated with 1 patient enrolled; no data due to patient privacy.
Arm/Group Title Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 1] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 2] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 3]
Hide Arm/Group Description:
Phase I dose level 1 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and the original starting troriluzole dose of 140 mg orally in the morning as well as 280 mg orally in the evening every day of each 21-day cycle. Participants were treated until disease progression or unacceptable toxicity.
Phase I dose level 2 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg twice per day orally. Participants were treated until disease progression or unacceptable toxicity.
Phase I dose level 3 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg/day orally. Participants were treated until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Median Overall Survival (OS)
Hide Description OS was defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive. Estimates of OS would be from a PHMC model.
Time Frame Participants were followed up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Terminated with 1 patient enrolled; no data due to patient privacy.
Arm/Group Title Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 1] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 2] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 3]
Hide Arm/Group Description:
Phase I dose level 1 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and the original starting troriluzole dose of 140 mg orally in the morning as well as 280 mg orally in the evening every day of each 21-day cycle. Participants were treated until disease progression or unacceptable toxicity.
Phase I dose level 2 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg twice per day orally. Participants were treated until disease progression or unacceptable toxicity.
Phase I dose level 3 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg/day orally. Participants were treated until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Intracranial Response Rate (RR)
Hide Description Intracranial response rate was defined as the proportion of participants who have achieved complete response (CR) or partial response (PR) based on modified RECIST 1.1.
Time Frame From enrollment to end of treatment up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Terminated with 1 patient enrolled; no data due to patient privacy.
Arm/Group Title Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 1] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 2] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 3]
Hide Arm/Group Description:
Phase I dose level 1 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and the original starting troriluzole dose of 140 mg orally in the morning as well as 280 mg orally in the evening every day of each 21-day cycle. Participants were treated until disease progression or unacceptable toxicity.
Phase I dose level 2 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg twice per day orally. Participants were treated until disease progression or unacceptable toxicity.
Phase I dose level 3 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg/day orally. Participants were treated until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Intracranial Progression-free Survival (PFS)
Hide Description Intracranial PFS was defined as the time from first dose of study therapy to documented intracranial progression or death, whichever occurs first. Per modified RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.
Time Frame From date of randomization until the date of first documented intracranial progression or date of death from any cause, whichever came first, assessed up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Terminated with 1 patient enrolled; no data due to patient privacy.
Arm/Group Title Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 1] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 2] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 3]
Hide Arm/Group Description:
Phase I dose level 1 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and the original starting troriluzole dose of 140 mg orally in the morning as well as 280 mg orally in the evening every day of each 21-day cycle. Participants were treated until disease progression or unacceptable toxicity.
Phase I dose level 2 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg twice per day orally. Participants were treated until disease progression or unacceptable toxicity.
Phase I dose level 3 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg/day orally. Participants were treated until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Extracranial Response Rate (RR)
Hide Description The extracranial response rate was defined as the proportion of participants who have achieved complete response or partial response based on Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) for all extracranial lesions.
Time Frame From enrollment to end of treatment up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Terminated with 1 patient enrolled; no data due to patient privacy.
Arm/Group Title Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 1] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 2] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 3]
Hide Arm/Group Description:
Phase I dose level 1 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and the original starting troriluzole dose of 140 mg orally in the morning as well as 280 mg orally in the evening every day of each 21-day cycle. Participants were treated until disease progression or unacceptable toxicity.
Phase I dose level 2 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg twice per day orally. Participants were treated until disease progression or unacceptable toxicity.
Phase I dose level 3 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg/day orally. Participants were treated until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Extracranial Progression-free Survival (PFS)
Hide Description Extracranial PFS is defined as the time from first dose of study therapy to documented extracranial progression (per RECIST) or death, whichever occurs first. Evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)39 for all extracranial lesions and modified RECIST 1.1 for all brain lesions
Time Frame From date of randomization until the date of first documented extracranial progression or date of death from any cause, whichever came first, assessed up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Terminated with 1 patient enrolled; no data due to patient privacy.
Arm/Group Title Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 1] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 2] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 3]
Hide Arm/Group Description:
Phase I dose level 1 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and the original starting troriluzole dose of 140 mg orally in the morning as well as 280 mg orally in the evening every day of each 21-day cycle. Participants were treated until disease progression or unacceptable toxicity.
Phase I dose level 2 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg twice per day orally. Participants were treated until disease progression or unacceptable toxicity.
Phase I dose level 3 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg/day orally. Participants were treated until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0
Hide Description The number and proportion of adverse events, graded as defined by CTCAE version 5.0 will be tabulated by type and grade.
Time Frame From enrollment to end of treatment up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Terminated with 1 patient enrolled; no data due to patient privacy.
Arm/Group Title Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 1] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 2] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 3]
Hide Arm/Group Description:
Phase I dose level 1 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and the original starting troriluzole dose of 140 mg orally in the morning as well as 280 mg orally in the evening every day of each 21-day cycle. Participants were treated until disease progression or unacceptable toxicity.
Phase I dose level 2 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg twice per day orally. Participants were treated until disease progression or unacceptable toxicity.
Phase I dose level 3 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg/day orally. Participants were treated until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Number of Induction
Hide Description Number of induction cycles was defined as the number of induction cycles administered.
Time Frame From enrollment to end of treatment up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Terminated with 1 patient enrolled; no data due to patient privacy.
Arm/Group Title Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 1] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 2] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 3]
Hide Arm/Group Description:
Phase I dose level 1 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and the original starting troriluzole dose of 140 mg orally in the morning as well as 280 mg orally in the evening every day of each 21-day cycle. Participants were treated until disease progression or unacceptable toxicity.
Phase I dose level 2 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg twice per day orally. Participants were treated until disease progression or unacceptable toxicity,
Phase I dose level 3 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg/day orally. Participants were treated until disease progression or unacceptable toxicity
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Number of Maintenance Cycles
Hide Description Number of maintenance cycles was defined as the number of maintenance cycles administered.
Time Frame From enrollment to end of treatment up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Terminated with 1 patient enrolled; no data due to patient privacy.
Arm/Group Title Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 1] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 2] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 3]
Hide Arm/Group Description:
Phase I dose level 1 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and the original starting troriluzole dose of 140 mg orally in the morning as well as 280 mg orally in the evening every day of each 21-day cycle. Participants were treated until disease progression or unacceptable toxicity.
Phase I dose level 2 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg twice per day orally. Participants were treated until disease progression or unacceptable toxicity,
Phase I dose level 3 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg/day orally. Participants were treated until disease progression or unacceptable toxicity
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Corticosteroids Usage
Hide Description Corticosteroids usage was defined by number of participants who require prednisone ≥1 mg/kg or equivalent.
Time Frame From enrollment to end of treatment up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Terminated with 1 patient enrolled; no data due to patient privacy.
Arm/Group Title Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 1] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 2] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 3]
Hide Arm/Group Description:
Phase I dose level 1 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and the original starting troriluzole dose of 140 mg orally in the morning as well as 280 mg orally in the evening every day of each 21-day cycle. Participants were treated until disease progression or unacceptable toxicity.
Phase I dose level 2 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg twice per day orally. Participants were treated until disease progression or unacceptable toxicity,
Phase I dose level 3 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg/day orally. Participants were treated until disease progression or unacceptable toxicity
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Frequency of Clinically-indicated Stereotactic Radiation Therapy to the Brain
Hide Description Frequency of clinically-indicated stereotactic radiation therapy to the brain was defined as the number of participants who received on-study brain-directed stereotactic radiation.
Time Frame From enrollment to end of treatment up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Terminated with 1 patient enrolled; no data due to patient privacy.
Arm/Group Title Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 1] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 2] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 3]
Hide Arm/Group Description:
Phase I dose level 1 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and the original starting troriluzole dose of 140 mg orally in the morning as well as 280 mg orally in the evening every day of each 21-day cycle. Participants were treated until disease progression or unacceptable toxicity.
Phase I dose level 2 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg twice per day orally. Participants were treated until disease progression or unacceptable toxicity,
Phase I dose level 3 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg/day orally. Participants were treated until disease progression or unacceptable toxicity
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Frequency of Clinically-indicated Surgical Intervention to the Brain
Hide Description Frequency of clinically-indicated surgical intervention to the brain was defined as the number of participants who received on-study surgical intervention to the brain.
Time Frame From enrollment to end of treatment up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Terminated with 1 patient enrolled; no data due to patient privacy."
Arm/Group Title Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 1] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 2] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 3]
Hide Arm/Group Description:
Phase I dose level 1 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and the original starting troriluzole dose of 140 mg orally in the morning as well as 280 mg orally in the evening every day of each 21-day cycle. Participants were treated until disease progression or unacceptable toxicity.
Phase I dose level 2 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg twice per day orally. Participants were treated until disease progression or unacceptable toxicity.
Phase I dose level 3 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg/day orally. Participants were treated until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Observation period regarding adverse event was up to 5 years from the start of treatment.
Adverse Event Reporting Description Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Per the source vocabulary (CTCAEv5.0) there is a category "Other, specify" for each system organ class. No further data is available to specify classification beyond this general term.
 
Arm/Group Title Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 1] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 2] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 3]
Hide Arm/Group Description Phase I dose level 1 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and the original starting troriluzole dose of 140 mg orally in the morning as well as 280 mg orally in the evening every day of each 21-day cycle. Participants were treated until disease progression or unacceptable toxicity. Phase I dose level 2 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg twice per day orally. Participants were treated until disease progression or unacceptable toxicity. Phase I dose level 3 participants received nivolumab 1 mg/kg and ipilimumab 3 mg/kg intravenously (IV) on day 1 of each 21-day cycle and troriluzole 140 mg/day orally. Participants were treated until disease progression or unacceptable toxicity.
All-Cause Mortality
Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 1] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 2] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 3]
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Hide Serious Adverse Events
Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 1] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 2] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 3]
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 1] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 2] Ipilimumab + Nivolumab + Troriluzole [Phase I Dose Level 3]
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Physician
Organization: Dana-Farber Cancer Institute
Phone: 6176326836
EMail: ann_silk@dfci.harvard.edu
Layout table for additonal information
Responsible Party: Ann W. Silk, MD MS, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT04899921    
Other Study ID Numbers: 20-675
First Submitted: April 16, 2021
First Posted: May 25, 2021
Results First Submitted: August 16, 2023
Results First Posted: December 13, 2023
Last Update Posted: March 26, 2024