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IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)
NCT06112314 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06112314
The ClinicalTrials.gov registry entry for NCT06112314 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 680 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Immunocore, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06112314 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Colorado, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06112314?
The interventions under investigation include: Nivolumab (DRUG), Nivolumab + Relatlimab (DRUG), Brenetafusp (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06112314?
This trial is sponsored by Immunocore, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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