Tests brenetafusp with nivolumab against standard nivolumab treatments in advanced melanoma
Tests brenetafusp plus nivolumab in adults with untreated advanced melanoma.
Plain-language title generated from the registry record
Registry title: IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)
Key facts
- Where
- Kaunas and Vilnius, LithuaniaSee the 2 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced melanoma that has not been treated before and who are HLA-A*02:01-positive.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Melanoma confirmed under the microscope as Stage IV, or Stage III that cannot be removed by surgery. The disease must be measurable (RECIST 1.1). ECOG performance status must be 0 or 1.
- Earlier treatment
- No earlier systemic anticancer treatment for melanoma that cannot be removed by surgery or has spread.
- Biomarker or test result
- HLA-A*02:01-positive. BRAF V600 mutation status must be known. A tumor tissue sample (archived or fresh) must be confirmed as adequate.
Main reasons for not taking part
- Another cancer in the past, other than the one treated in this trial
- Untreated, active or symptomatic cancer spread to the brain or spinal cord area (CNS metastases or carcinomatous meningitis)
- Active autoimmune disease that needs treatment lowering the immune system
- Significant lung or heart disease or poor lung or heart function
- Past life-threatening side effect from earlier anti-PD-(L)1 or anti-LAG-3 treatment
Read by machine on 9 November 2026.
Where in Lithuania
- Hospital of Lithuanian University of Health Sciences Kauno KlinikosKaunas, LithuaniaTaking people
- Vilnius University Hospital Santaros Clinics Affiliate National Cancer CenterVilnius, LithuaniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Immunocore Ltd
- Trial code
- NCT06112314
- Record updated
- 25 February 2026
- Original description
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.Read full original descriptionShow less
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
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.
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 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; Participants with a history of a malignant disease other than those being treated in this study; 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 with untreated, active, or symptomatic central nervous system (CNS) metastases or carcinomatous meningitis.