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Checkpoint Inhibitor

Troriluzole for Melanoma

Phase 2
Waitlist Available
Led By Ann W Silk, MD, MS
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up participants were followed up to 5 years.
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat melanoma that has spread to the brain. They want to see if it is safe and effective.

Eligible Conditions
  • Melanoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants were followed up to 5 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and participants were followed up to 5 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Median Global Progression-Free Survival (PFS)
Secondary outcome measures
Corticosteroids Usage
Extracranial Progression-free Survival (PFS)
Extracranial Response Rate (RR)
+8 more

Side effects data

From 2020 Phase 3 trial • 881 Patients • NCT03829241
9%
Nausea
5%
Fatigue
5%
Upper respiratory tract infection
4%
Headache
3%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo - Randomization Phase/Troriluzole - Extension Phase
Troriluzole - Randomization Phase
Placebo - Randomization Phase
Troriluzole - Randomization Phase/Troriluzole - Extension Phase

Trial Design

5Treatment groups
Experimental Treatment
Group I: Ipilimumab + Nivolumab + Troriluzole [Phase II]Experimental Treatment3 Interventions
Participants will be randomly assigned and receive: 12 Week Induction Phase: Nivolumab at pre-determined dose followed by ipilimumab at predetermined dose every 3 weeks, with 21 consecutive days defined as a treatment cycle. Troriluzole self-administered at a predetermined dose orally twice a day 36 Week Maintenance Phase: Nivolumab will be administered every 4 weeks, with 28 consecutive days defined as a treatment cycle. Troriluzole self administered at a predetermined dose orally twice a day. No ipilimumab will be given in the maintenance phase.
Group II: Ipilimumab + Nivolumab + Troriluzole [Phase I dose level 3]Experimental Treatment3 Interventions
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.
Group III: Ipilimumab + Nivolumab + Troriluzole [Phase I dose level 2]Experimental Treatment3 Interventions
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.
Group IV: Ipilimumab + Nivolumab + Troriluzole [Phase I dose level 1]Experimental Treatment3 Interventions
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.
Group V: Ipilimumab + Nivolumab + Placebo [Phase II]Experimental Treatment3 Interventions
Participants will be randomly assigned and receive: 12 Week Induction Phase: Nivolumab at pre-determined dose followed by ipilimumab at predetermined dose every 3 weeks, with 21 consecutive days defined as a treatment cycle. Placebo self-administered at a predetermined dose orally twice a day 36 Week Maintenance Phase: Nivolumab will be administered every 4 weeks, with 28 consecutive days defined as a treatment cycle. Placebo self administered at a predetermined dose orally twice a day. No ipilimumab will be given in the maintenance phase.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
FDA approved
Nivolumab
FDA approved
Troriluzole
Not yet FDA approved
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,871 Total Patients Enrolled
32 Trials studying Melanoma
2,909 Patients Enrolled for Melanoma
Biohaven Pharmaceuticals, Inc.Industry Sponsor
47 Previous Clinical Trials
37,417 Total Patients Enrolled
Ann W Silk, MD, MSPrincipal InvestigatorDana-Farber Cancer Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Troriluzole or Placebo Plus Ipi Plus Nivo in Mel Brain Mets
Ann W. Silk, MD MS 2021. "Troriluzole or Placebo Plus Ipi Plus Nivo in Mel Brain Mets". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04899921.
~0 spots leftby Apr 2025
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