Trial Outcomes & Findings for Trigriluzole With Nivolumab and Pembrolizumab in Treating Patients With Metastatic or Unresectable Solid Malignancies or Lymphoma (NCT NCT03229278)

Last Updated: 2023-12-06

Results Overview

The MTD of trigriluzole in combination with nivolumab will be identified. The MTD will then be tested in combination with pembrolizumab using the same escalate/de-escalate/stay rules. Data on the adverse event type, severity and frequency will be recorded.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

14 participants

Primary outcome timeframe

Four weeks

Results posted on

2023-12-06

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg Taken by Mouth Daily (PO) Cohort 1: Participants were administered 240 mg of Nivolumab every two weeks, via intravenous catheter (IV), for 2 weeks, and Trigriluzole 140 mg (PO), with one year of follow-up after the start of treatment. Once the MTD of Trigriluzole with nivolumab is identified, participants receive pembrolizumab IV over 30 minutes every 3 weeks beginning week 1 and Trigriluzole PO. Treatment repeats for up to 1 year in the absence of disease progression or unacceptable toxicity.	Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg PO Twice a Day (BID) Cohort 2: Participants were administered 240 mg of Nivolumab every two weeks, via intravenous catheter (IV), for 2 weeks, and Trigriluzole 140 mg (PO) Twice a day (BID), with one year of follow-up after the start of treatment. Once the MTD of Trigriluzole with nivolumab is identified, participants receive pembrolizumab IV over 30 minutes every 3 weeks beginning week 1 and Trigriluzole PO. Treatment repeats for up to 1 year in the absence of disease progression or unacceptable toxicity.	Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg /280mg Cohort 3: Participants were administered 240 mg of Nivolumab every two weeks, via intravenous catheter (IV) and Trigriluzole 140 mg (PO) once a day in the morning (QAM) and 280mg PO every night at bedtime (QHS), with one year of follow-up after the start of treatment. Once the MTD of Trigriluzole with nivolumab is identified, participants receive pembrolizumab IV over 30 minutes every 3 weeks beginning week 1 and Trigriluzole PO. Treatment repeats for up to 1 year in the absence of disease progression or unacceptable toxicity.	Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 280mg PO BID Cohort 4: Participants were administered 240 mg of Nivolumab every two weeks, via intravenous catheter (IV) and Trigriluzole 140 mg (PO) once a day in the morning (QAM) and 280mg PO every night at bedtime (QHS), with one year of follow-up after the start of treatment. Once the MTD of Trigriluzole with nivolumab is identified, participants receive pembrolizumab IV over 30 minutes every 3 weeks beginning week 1 and Trigriluzole 200mg PO BID. Treatment repeats for up to 1 year in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	3	6	3	2
Overall Study COMPLETED	3	6	3	2
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trigriluzole With Nivolumab and Pembrolizumab in Treating Patients With Metastatic or Unresectable Solid Malignancies or Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg Taken by Mouth Daily (PO) n=3 Participants Cohort 1: Participants were administered 240 mg of Nivolumab every two weeks, via intravenous catheter (IV), for 2 weeks, and Trigriluzole 140 mg (PO), with one year of follow-up after the start of treatment. Once the MTD of Trigriluzole with nivolumab is identified, participants receive pembrolizumab IV over 30 minutes every 3 weeks beginning week 1 and Trigriluzole PO. Treatment repeats for up to 1 year in the absence of disease progression or unacceptable toxicity.	Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg PO Twice a Day (BID) n=6 Participants Cohort 2: Participants were administered 240 mg of Nivolumab every two weeks, via intravenous catheter (IV), for 2 weeks, and Trigriluzole 140 mg (PO) Twice a day (BID), with one year of follow-up after the start of treatment. Once the MTD of Trigriluzole with nivolumab is identified, participants receive pembrolizumab IV over 30 minutes every 3 weeks beginning week 1 and Trigriluzole PO. Treatment repeats for up to 1 year in the absence of disease progression or unacceptable toxicity.	Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg /280mg n=3 Participants Cohort 3: Participants were administered 240 mg of Nivolumab every two weeks, via intravenous catheter (IV) and Trigriluzole 140 mg (PO) once a day in the morning (QAM) and 280mg PO every night at bedtime (QHS), with one year of follow-up after the start of treatment. Once the MTD of Trigriluzole with nivolumab is identified, participants receive pembrolizumab IV over 30 minutes every 3 weeks beginning week 1 and Trigriluzole PO. Treatment repeats for up to 1 year in the absence of disease progression or unacceptable toxicity.	Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 280mg PO BID n=2 Participants Cohort 4: Participants were administered 240 mg of Nivolumab every two weeks, via intravenous catheter (IV) and Trigriluzole 140 mg (PO) once a day in the morning (QAM) and 280mg PO every night at bedtime (QHS), with one year of follow-up after the start of treatment. Once the MTD of Trigriluzole with nivolumab is identified, participants receive pembrolizumab IV over 30 minutes every 3 weeks beginning week 1 and Trigriluzole 200mg PO BID. Treatment repeats for up to 1 year in the absence of disease progression or unacceptable toxicity.	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	8 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	12 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: Four weeks

Outcome measures

Outcome measures
Measure	All Participants n=14 Participants All participants who received at least 1 dose of Trigriluzole (140 mg or 280mg ) in combination with Nivolumab (240mg IV)	Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg PO Twice a Day (BID) Cohort 2: Participants were administered 240 mg of Nivolumab every two weeks, via intravenous catheter (IV), for 2 weeks, and Trigriluzole 140 mg (PO) Twice a day (BID), with one year of follow-up after the start of treatment. Once the MTD of Trigriluzole with nivolumab is identified, participants receive pembrolizumab IV over 30 minutes every 3 weeks beginning week 1 and Trigriluzole PO. Treatment repeats for up to 1 year in the absence of disease progression or unacceptable toxicity.	Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg /280mg Cohort 3: Participants were administered 240 mg of Nivolumab every two weeks, via intravenous catheter (IV) and Trigriluzole 140 mg (PO) once a day in the morning (QAM) and 280mg PO every night at bedtime (QHS), with one year of follow-up after the start of treatment. Once the MTD of Trigriluzole with nivolumab is identified, participants receive pembrolizumab IV over 30 minutes every 3 weeks beginning week 1 and Trigriluzole PO. Treatment repeats for up to 1 year in the absence of disease progression or unacceptable toxicity.	Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 280mg PO BID Cohort 4: Participants were administered 240 mg of Nivolumab every two weeks, via intravenous catheter (IV) and Trigriluzole 140 mg (PO) once a day in the morning (QAM) and 280mg PO every night at bedtime (QHS), with one year of follow-up after the start of treatment. Once the MTD of Trigriluzole with nivolumab is identified, participants receive pembrolizumab IV over 30 minutes every 3 weeks beginning week 1 and Trigriluzole 200mg PO BID. Treatment repeats for up to 1 year in the absence of disease progression or unacceptable toxicity.
Maximum Tolerated Dose (MTD))/Recommended Phase 2 Dose of Trigriluzole	420 mg	—	—	—

SECONDARY outcome

Timeframe: Four weeks

A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants who received at least 1 dose of Trigriluzole (140 mg or 280mg ) in combination with Nivolumab (240mg IV)	Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg PO Twice a Day (BID) n=6 Participants Cohort 2: Participants were administered 240 mg of Nivolumab every two weeks, via intravenous catheter (IV), for 2 weeks, and Trigriluzole 140 mg (PO) Twice a day (BID), with one year of follow-up after the start of treatment. Once the MTD of Trigriluzole with nivolumab is identified, participants receive pembrolizumab IV over 30 minutes every 3 weeks beginning week 1 and Trigriluzole PO. Treatment repeats for up to 1 year in the absence of disease progression or unacceptable toxicity.	Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg /280mg n=3 Participants Cohort 3: Participants were administered 240 mg of Nivolumab every two weeks, via intravenous catheter (IV) and Trigriluzole 140 mg (PO) once a day in the morning (QAM) and 280mg PO every night at bedtime (QHS), with one year of follow-up after the start of treatment. Once the MTD of Trigriluzole with nivolumab is identified, participants receive pembrolizumab IV over 30 minutes every 3 weeks beginning week 1 and Trigriluzole PO. Treatment repeats for up to 1 year in the absence of disease progression or unacceptable toxicity.	Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 280mg PO BID n=2 Participants Cohort 4: Participants were administered 240 mg of Nivolumab every two weeks, via intravenous catheter (IV) and Trigriluzole 140 mg (PO) once a day in the morning (QAM) and 280mg PO every night at bedtime (QHS), with one year of follow-up after the start of treatment. Once the MTD of Trigriluzole with nivolumab is identified, participants receive pembrolizumab IV over 30 minutes every 3 weeks beginning week 1 and Trigriluzole 200mg PO BID. Treatment repeats for up to 1 year in the absence of disease progression or unacceptable toxicity.
Number of Participants Who Experienced Dose-Limiting Toxicities (DLT)	0 Participants	0 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to 3 years

Continuous variables will be presented by summary statistics (such as mean, median, standard error and 95% confidence intervals \[CI\]) and the categorical variables by frequency distributions (i.e., frequency counts, percentages and 95% CI).

Outcome measures

Outcome measures
Measure	All Participants n=14 Participants All participants who received at least 1 dose of Trigriluzole (140 mg or 280mg ) in combination with Nivolumab (240mg IV)	Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg PO Twice a Day (BID) Cohort 2: Participants were administered 240 mg of Nivolumab every two weeks, via intravenous catheter (IV), for 2 weeks, and Trigriluzole 140 mg (PO) Twice a day (BID), with one year of follow-up after the start of treatment. Once the MTD of Trigriluzole with nivolumab is identified, participants receive pembrolizumab IV over 30 minutes every 3 weeks beginning week 1 and Trigriluzole PO. Treatment repeats for up to 1 year in the absence of disease progression or unacceptable toxicity.	Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg /280mg Cohort 3: Participants were administered 240 mg of Nivolumab every two weeks, via intravenous catheter (IV) and Trigriluzole 140 mg (PO) once a day in the morning (QAM) and 280mg PO every night at bedtime (QHS), with one year of follow-up after the start of treatment. Once the MTD of Trigriluzole with nivolumab is identified, participants receive pembrolizumab IV over 30 minutes every 3 weeks beginning week 1 and Trigriluzole PO. Treatment repeats for up to 1 year in the absence of disease progression or unacceptable toxicity.	Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 280mg PO BID Cohort 4: Participants were administered 240 mg of Nivolumab every two weeks, via intravenous catheter (IV) and Trigriluzole 140 mg (PO) once a day in the morning (QAM) and 280mg PO every night at bedtime (QHS), with one year of follow-up after the start of treatment. Once the MTD of Trigriluzole with nivolumab is identified, participants receive pembrolizumab IV over 30 minutes every 3 weeks beginning week 1 and Trigriluzole 200mg PO BID. Treatment repeats for up to 1 year in the absence of disease progression or unacceptable toxicity.
Objective Response Rate Assessed According to Response Evaluation Criteria in Solid Tumors Version 1.1	7 percentage of participants Interval 0.2 to 33.9	—	—	—

SECONDARY outcome

Timeframe: Up to 3 years

Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg Taken by Mouth Daily (PO)

Serious events: 3 serious events

Other events: 3 other events

Deaths: 2 deaths

Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg PO Twice a Day (BID)

Serious events: 4 serious events

Other events: 6 other events

Deaths: 3 deaths

Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg /280mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 2 deaths

Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 280mg PO BID

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg Taken by Mouth Daily (PO) n=3 participants at risk Cohort 1: Participants were administered 240 mg of Nivolumab every two weeks, via intravenous catheter (IV), for 2 weeks, and Trigriluzole 140 mg (PO), with one year of follow-up after the start of treatment. Once the MTD of Trigriluzole with nivolumab is identified, participants receive pembrolizumab IV over 30 minutes every 3 weeks beginning week 1 and Trigriluzole PO. Treatment repeats for up to 1 year in the absence of disease progression or unacceptable toxicity.	Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg PO Twice a Day (BID) n=6 participants at risk Cohort 2: Participants were administered 240 mg of Nivolumab every two weeks, via intravenous catheter (IV), for 2 weeks, and Trigriluzole 140 mg (PO) Twice a day (BID), with one year of follow-up after the start of treatment. Once the MTD of Trigriluzole with nivolumab is identified, participants receive pembrolizumab IV over 30 minutes every 3 weeks beginning week 1 and Trigriluzole PO. Treatment repeats for up to 1 year in the absence of disease progression or unacceptable toxicity.	Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 140 mg /280mg n=3 participants at risk Cohort 3: Participants were administered 240 mg of Nivolumab every two weeks, via intravenous catheter (IV) and Trigriluzole 140 mg (PO) once a day in the morning (QAM) and 280mg PO every night at bedtime (QHS), with one year of follow-up after the start of treatment. Once the MTD of Trigriluzole with nivolumab is identified, participants receive pembrolizumab IV over 30 minutes every 3 weeks beginning week 1 and Trigriluzole PO. Treatment repeats for up to 1 year in the absence of disease progression or unacceptable toxicity.	Experimental: Nivolumab 240mg IV Every 2 Weeks - Trigriluzole 280mg PO BID n=14 participants at risk Cohort 4: Participants were administered 240 mg of Nivolumab every two weeks, via intravenous catheter (IV) and Trigriluzole 140 mg (PO) once a day in the morning (QAM) and 280mg PO every night at bedtime (QHS), with one year of follow-up after the start of treatment. Once the MTD of Trigriluzole with nivolumab is identified, participants receive pembrolizumab IV over 30 minutes every 3 weeks beginning week 1 and Trigriluzole 200mg PO BID. Treatment repeats for up to 1 year in the absence of disease progression or unacceptable toxicity.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.	0.00% 0/6 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.	0.00% 0/3 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.	7.1% 1/14 • Number of events 1 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • Number of events 3 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.	0.00% 0/6 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.	0.00% 0/3 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.	0.00% 0/14 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.	0.00% 0/6 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.	0.00% 0/3 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.	0.00% 0/14 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.
Gastrointestinal disorders Esophagitis	33.3% 1/3 • Number of events 3 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.	0.00% 0/6 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.	0.00% 0/3 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.	0.00% 0/14 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.	33.3% 2/6 • Number of events 2 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.	0.00% 0/3 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.	0.00% 0/14 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/3 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.	0.00% 0/6 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.	0.00% 0/3 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.	7.1% 1/14 • Number of events 1 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.
Nervous system disorders Intracranial hemorrhage	33.3% 1/3 • Number of events 2 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.	33.3% 2/6 • Number of events 2 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.	0.00% 0/3 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.	0.00% 0/14 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.
Vascular disorders Thromboembolic event	33.3% 1/3 • Number of events 1 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.	0.00% 0/6 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.	0.00% 0/3 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.	0.00% 0/14 • From baseline and up to three years after the last dose A DLT was any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) that was possibly Trigriluzole or Nivolumab related. CTCAE 3.0 Grade 3 is a severe AE and Grade 4 is a life- threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which 33% of participants experienced a DLT.

Other adverse events

Additional Information

Dr. Biren Saraiya - Associate Professor of Medicine Medical Director, Office of Human Research Servi

Cancer Institute of New Jersey Rutgers

Phone: 732-235-5773

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place