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
- Bari, Bergamo, Meldola, Milan, Modena, Naples, Padova, Perugia, Ponderano, Roma, Siena, and Torino, ItalySee the 14 sites
- Phase
- Phase 3
Where in Italy
- Istituto Tumori Giovanni Paolo II - Ospedale Oncologico di BariBari, ItalyTaking people
- Humanitas Gavazzeni (Cliniche Gavazzeni S.p.A)Bergamo, ItalyTaking people
- IRCCS Istituto Scientifico Romagnolo per lo Studio dei Tumori "Dino Amadori" Srl (IRST)Meldola, ItalyTaking people
- Fondazione IRCCS - Istituto Nazionale dei Tumori - MilanoMilan, ItalyTaking people
- Istituto Europeo di Oncologia (IEO) (European Institute of Oncology)Milan, ItalyTaking people
- Azienda Ospedaliero-Universitaria di Modena (AOU Modena) - Policlinico di Modena - Day Hospital OncologicoModena, ItalyTaking people
- Istituto Nazionale Tumori (INT) "Fondazione G. Pascale" di NapoliNaples, ItalyTaking people
- Istituto Oncologico Veneto IOV-IRCCSPadova, ItalyTaking people
- Azienda Ospedaliera di Perugia Ospedale Santa Maria della MisericordiaPerugia, ItalyTaking people
- Azienda Sanitaria Locale di Biella (ASL BI) - Ospedale degli InfermiPonderano, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, ItalyTaking people
- National Cancer Institute Regina ElenaRoma, ItalyTaking people
- " Azienda Ospedaliera Universitaria Senese - Policlinico Santa Maria Alle Scotte - Clinica Immunoterapia Oncologica"Siena, ItalyTaking people
- Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di TorinoTorino, ItalyTaking 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.