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PRISM-MEL-301: Brenetafusp and Nivolumab for Advanced Melanoma

This study is testing a new combination of medicines, brenetafusp and nivolumab, against standard nivolumab treatments for people with advanced melanoma that hasn't been treated before. Researchers want to see if the brenetafusp combination can help you live longer without your cancer getting worse (this is called Progression-Free Survival). To join, you must have a specific genetic marker called HLA-A*02:01, and your melanoma must be advanced or unable to be removed by surgery. You also need to have measurable disease and provide a tumor tissue sample. The study plans to enroll about 680 participants.

Study design
This is a Phase 3, randomized study comparing different drug regimens. About 680 participants are planned to be enrolled.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your health will be followed for up to about 45 months to see how long you live without your cancer getting worse.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06112314

IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Immunocore Ltd
~680 participants
Updated 2026-02-25 on ClinicalTrials.gov
What's tested:BrenetafuspNivolumabNivolumab + Relatlimab

At a glance

Recruiting sites
201 of 211 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS)
Measured over Up to ~45 months

Conditions

Advanced Melanoma

Explore related trials

MelanomaHLA Class I Histocompatibility Antigen, A-0201 Alpha Chain

NCT06112314

Where you'd take part

This study runs at 211 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • A.C.Camargo Cancer Center - Centro Internacional de Pesquisa (CIPE)

    Liberdade, Brazilstudy coordinator listed

    Recruiting

  • AKH - Medizinische Universität Wien

    Vienna, Austriastudy coordinator listed

    Recruiting

  • Allina Health Cancer Institute - Minneapolis

    Minneapolis, Minnesotastudy coordinator listed

    Recruiting

  • AZ Sint-Jan Brugge-Oostende AV-Campus Sint-Jan

    Bruges, Belgiumstudy coordinator listed

    Recruiting

  • Beatson West of Scotland Cancer Centre

    Glasgow, United Kingdomstudy coordinator listed

    Recruiting

  • Calvary Mater Newcastle Hospital

    Waratah, New South Wales, Australiastudy coordinator listed

    Recruiting

  • CEMAIC (Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

    Córdoba, Argentinastudy coordinator listed

    Recruiting

  • Centre Hospitalier Universitaire de Lille (CHU Lille)-Hopital Claude Huriez

    Lille, Francestudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Immunocore Medical Information
[email protected]
844-466-8661
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Progression-Free Survival (PFS)Up to ~45 months

    PFS as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumours (RECIST 1.1).