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NCT04139902 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant PD-1 Inhibitor Dostarlimab (TSR-042) vs. Combination of Tim-3 Inhibitor Cobolimab (TSR-022) and PD-1 Inhibitor Dostarlimab (TSR-042) in Melanoma
A Phase 2 study of Melanoma Stage IV and Melanoma Stage III, sponsored by Diwakar Davar.
- Active
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 5
- Study locations
NCT04139902: Active Phase 2 study of Melanoma Stage IV and Melanoma Stage III, sponsored by Diwakar Davar.
NCT04139902 is a Phase 2 study of Melanoma Stage IV and Melanoma Stage III that is active but no longer recruiting, run by Diwakar Davar. The registered enrollment target is 48 participants, below the 100-participant average among 17 other Melanoma Stage IV trials with a reported enrollment target (52% lower). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04139902, a Phase 2 study of Melanoma Stage IV and Melanoma Stage III, is active but no longer recruiting, sponsored by Diwakar Davar.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of this study is to test the effects of anti-PI-1 inhibitor (TSR-042) or anti-PD-1/anti-TIM-3 combination (TSR-042 / TSR-022) in patients with operable melanoma.
Primary Outcome
Proportion of patients with an RVT (residual volume of viable tumor) of ≤10% remaining in post-therapy specimen using immunotherapy-specific pathologic assessment of neoadjuvant treated melanoma specimens.
Conditions Studied
Interventions
- DRUG Dostarlimab (TSR-042) (singly)
- DRUG Dostarlimab (TSR-042) and TSR-022 (combination)
Study Locations (5)
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute - Boston
Pennsylvania
- UPMC Hillman Cancer Center - Pittsburgh
- UPMC Hillman Cancer Center Washington - Washington
District of Columbia
- Georgetown University Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2020-06-12 |
| Est. Completion | 2029-12-15 |
| Phase | Phase 2 |
What the registry record for NCT04139902 still lists
NCT04139902 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 100-participant average among 17 other Melanoma Stage IV trials with a reported enrollment target (52% lower).
The record links to 2 conditions, with Melanoma Stage IV appearing as the primary indexed condition, and to 2 interventions - of which Dostarlimab (TSR-042) (singly) is the first listed.
NCT04139902 lists 5 locations in 3 states (Massachusetts, Pennsylvania, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT04139902 about?
NCT04139902 is a clinical study titled "Neoadjuvant PD-1 Inhibitor Dostarlimab (TSR-042) vs. Combination of Tim-3 Inhibitor Cobolimab (TSR-022) and PD-1 Inhibitor Dostarlimab (TSR-042) in Melanoma". The purpose of this study is to test the effects of anti-PI-1 inhibitor (TSR-042) or anti-PD-1/anti-TIM-3 combination (TSR-042 / TSR-022) in patients with operable melanoma.
What is the current status of trial NCT04139902?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2020-06-12. Estimated completion is 2029-12-15.
What conditions does trial NCT04139902 study?
This clinical trial studies the following conditions: Melanoma Stage IV, Melanoma Stage III.
What interventions are being tested in trial NCT04139902?
The interventions under investigation include: Dostarlimab (TSR-042) (singly) (DRUG), Dostarlimab (TSR-042) and TSR-022 (combination) (DRUG).
Who is sponsoring clinical trial NCT04139902?
This trial is sponsored by Diwakar Davar, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04139902 being conducted?
This trial has 5 study locations across District of Columbia, Massachusetts, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Melanoma Stage IV
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04139902's enrollment target sits among peer trials
48 12th of 17 higher than 6 of 17 other Melanoma Stage IV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma Stage IV 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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