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NCT04899921 · ClinicalTrials.gov registry record · Phase 2
Troriluzole or Placebo Plus Ipi Plus Nivo in Mel Brain Mets
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT04899921: Clinical Trial Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT04899921 is a Phase 2 study that was terminated before completion, run by Dana-Farber Cancer Institute. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04899921, a Phase 2 study, was terminated before completion, sponsored by Dana-Farber Cancer Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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
Interventions
- DRUG Placebo
- DRUG Nivolumab
- DRUG Ipilimumab
- DRUG Troriluzole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2021-06-30 |
| Est. Completion | 2023-05-29 |
| Phase | Phase 2 |
Why NCT04899921 stopped before completion
NCT04899921 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04899921 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04899921 about?
NCT04899921 is a clinical study titled "Troriluzole or Placebo Plus Ipi Plus Nivo in Mel Brain Mets". 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.
What is the current status of trial NCT04899921?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2021-06-30. Estimated completion is 2023-05-29.
What interventions are being tested in trial NCT04899921?
The interventions under investigation include: Placebo (DRUG), Nivolumab (DRUG), Ipilimumab (DRUG), Troriluzole (DRUG).
Who is sponsoring clinical trial NCT04899921?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04899921's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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