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Protocol # 20-675

Status

Recruiting

Description

The purpose of this research is to test the safety and effectiveness of the investigational combination of Troriluzole, ipilimumab, and nivolumab, and to learn whether this combination works in treating melanoma that has spread to the brain.

Condition

  • Melanoma
  • Metastatic Melanoma

Interventions

  • Ipilimumab
  • Nivolumab
  • Troriluzole
  • Placebo

Phase

Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Progression-free survival (PFS)

Secondary Outcome:

  • Overall survival
  • Intracranial response rate (RR)
  • Intracranial progression-free survival (PFS)
  • Extracranial response rate (RR)
  • Extracranial progression-free survival (PFS)
  • Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0
  • Tolerability of Intervention
  • Corticosteroids usage
  • Frequency of clinically-indicated stereotactic radiation therapy to the brain
  • Frequency of clinically-indicated surgical intervention to the brain

Enrollment

108

Study Start Date

June 30, 2021

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Dana-Farber Cancer Institute

Source

Dana-Farber Cancer Institute

Official title

A Blinded, Randomized Phase 2 Study of Troriluzole in Combination With Ipilimumab and Nivolumab in Patients With Melanoma Brain Metastases Previously Treated With Anti-PD-1 Therapy

Clinicaltrials.gov Identifier

NCT04899921

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.