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Comparing two treatments for advanced melanoma

A Phase 3 Randomized, Controlled Study of IMC-F106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301

Phase 3 Interventional Immunocore Ltd · NCT06112314

This study is testing if a new combination treatment for advanced melanoma can work better than the standard treatment for patients who have not received treatment before.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment680 (estimated)
Ages18 Years and up
SexAll
SponsorImmunocore Ltd Industry-sponsored
Drugs / interventionsnivolumab, relatlimab
Locations211 sites (Tucson, Arizona and 210 other locations)
Trial IDNCT06112314 on ClinicalTrials.gov

What this trial studies

This phase 3, randomized, controlled trial evaluates the effectiveness of brenetafusp (IMC-F106C) combined with nivolumab against standard nivolumab regimens in patients with previously untreated advanced melanoma who are HLA-A*02:01-positive. The study aims to determine if the combination therapy can provide better outcomes than the standard treatment. Participants must have measurable disease and meet specific eligibility criteria, including having a confirmed diagnosis of Stage IV or unresectable Stage III melanoma.

Who should consider this trial

Good fit: Ideal candidates are HLA-A*02:01-positive individuals with histologically confirmed Stage IV or unresectable Stage III melanoma.

Not a fit: Patients with untreated, active central nervous system metastases or those with a history of other malignant diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a more effective treatment option for patients with advanced melanoma.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, suggesting potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participants must be HLA-A\*02:01-positive
* Participants must have histologically confirmed Stage IV or unresectable Stage III melanoma
* Archived or fresh tumor tissue sample that must be confirmed as adequate
* Participants must have measurable disease per RECIST 1.1
* Participant must have BRAF V600 mutation status determined
* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control from the study screening date until 5 months after the final dose of study intervention

Exclusion Criteria:

* Participants with a history of a malignant disease other than those being treated in this study
* Participants with untreated, active, or symptomatic central nervous system (CNS) metastases or carcinomatous meningitis
* Hypersensitivity to IMC-F106C, nivolumab, relatlimab, or any associated excipients
* Participants with clinically significant pulmonary disease or impaired lung function
* Participants with clinically significant cardiac disease or impaired cardiac function
* Participants with active autoimmune disease requiring immunosuppressive treatment
* Participants with any medical condition that is poorly controlled or that would, in the Investigator's or Sponsor's judgment, adversely impact the participant's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results
* Participants who received prior systemic anticancer therapy for unresectable or metastatic melanoma
* Participants with a history of a life-threatening AE related to prior anti-PD-(L)1 or anti-LAG-3

Where this trial is running

Tucson, Arizona and 210 other locations

+161 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Melanoma
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.