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NCT06112314 · ClinicalTrials.gov registry record · Phase 3
IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)
A Phase 3 study of Advanced Melanoma, sponsored by Immunocore.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 680
- Enrollment target
- 20
- Study locations
NCT06112314: Recruiting Phase 3 study of Advanced Melanoma, sponsored by Immunocore.
NCT06112314 is a Phase 3 study of Advanced Melanoma that is actively recruiting participants, run by Immunocore. The registered enrollment target is 680 participants, above the 139-participant average among 21 other Advanced Melanoma trials with a reported enrollment target (389% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06112314, a Phase 3 study of Advanced Melanoma, is actively recruiting participants, sponsored by Immunocore.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 680 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a phase 3, randomized, controlled study of brenetafusp (IMC-F106C) plus nivolumab compared to standard nivolumab regimens in HLA-A\*02:01-positive participants with previously untreated advanced melanoma.
Primary Outcome
PFS as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Nivolumab + Relatlimab
- DRUG Brenetafusp
Study Locations (20)
California
- University of California - San Diego - La Jolla
- The Angeles Clinic and Research Institute- West Los Angeles - Los Angeles
- ESC Norris Comprehensive Cancer Center - Los Angeles
- UCLA Hematology/Oncology - Los Angeles
- Stanford Cancer Institute - Stanford Cancer Center Palo Alto - Palo Alto
- Saint John's Health Center - John Wayne Cancer Institute (JWCI) - Santa Monica
Colorado
- University of Colorado, Anschutz Medical Campus - Aurora
- The Melanoma & Skin Cancer Institute - Denver
Florida
- Mayo Clinic Florida - Jacksonville
- University of Miami Health System-Sylvester Comprehensive Cancer Center-Miami - Miami
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute - Boston
Arizona
- University of Arizona - Tucson
Connecticut
- UConn Health-Farmington (University of Connecticut Health Center (UCHC)) - Farmington
District of Columbia
- Georgetown University - Washington D.C.
Illinois
- Northwestern University - Robert H. Lurie Comprehensive Cancer Center - NMDTI - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 680 participants |
| Start Date | 2024-06-05 |
| Est. Completion | 2027-10-16 |
| Phase | Phase 3 |
What NCT06112314 shows while recruiting
NCT06112314 is an interventional study that assigns participants to a tested intervention. The registered 680 participants enrollment target is mid-sized for trials with a published cap, above the 139-participant average among 21 other Advanced Melanoma trials with a reported enrollment target (389% higher).
The record links to 1 condition, with Advanced Melanoma appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT06112314 names 20 study sites across 12 states, led by California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT06112314 about?
NCT06112314 is a clinical study titled "IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)". This is a phase 3, randomized, controlled study of brenetafusp (IMC-F106C) plus nivolumab compared to standard nivolumab regimens in HLA-A\*02:01-positive participants with previously untreated advanced melanoma.
What is the current status of trial NCT06112314?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 680 participants. The study started on 2024-06-05. Estimated completion is 2027-10-16.
What conditions does trial NCT06112314 study?
This clinical trial studies the following conditions: Advanced Melanoma.
What interventions are being tested in trial NCT06112314?
The interventions under investigation include: Nivolumab (DRUG), Nivolumab + Relatlimab (DRUG), Brenetafusp (DRUG).
Who is sponsoring clinical trial NCT06112314?
This trial is sponsored by Immunocore, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06112314 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Melanoma
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 NCT06112314's enrollment target sits among peer trials
680 2nd of 21 the highest of 21 other Advanced Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Melanoma 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.
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