NCT06112314Recruiting
IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)
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.
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
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, Austria, United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Czechia, Denmark, Finland, Hungary, Lithuania, Mexico, Norway, Poland, Portugal, Romania, Spain, Sweden, Turkey (Türkiye), United Kingdom
- Sponsor
- Immunocore Ltd(Industry)
- Protocol no.
- IMC-F106C-301
- Conditions
- Advanced Melanoma
- Interventions
- Drug
Treatments studied
- Brenetafusp
- Nivolumab
- Nivolumab + Relatlimab
Locations · 201
- Zurich, SwitzerlandUniversitaetsSpital Zuerich - Dermatologische KlinikRecruiting at this site
- Marseille, FranceHôpital de la TimoneRecruiting at this site
- Toulouse, FranceOncopole Claudius Regaud- Institut Universitaire du Cancer de ToulouseRecruiting at this site
- Boulogne-Billancourt, FranceAssistance Publique-Hopitaux de Paris (AP-HP) - Hopital Ambroise-PareRecruiting at this site
- Caen, FranceUNICANCER-Centre Francois Baclesse (CFB)Recruiting at this site
- Dijon, FranceCHU de Dijon Bourgogne - Hôpital François MitterrandRecruiting at this site
- Lille, FranceCentre Hospitalier Universitaire de Lille (CHU Lille)-Hopital Claude HuriezRecruiting at this site
- Nantes, FranceCentre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-DieuRecruiting at this site
- Paris, FranceHospital Saint LouisRecruiting at this site
- Pierre-Bénite, FranceHospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-SudRecruiting at this site
- Rouen, FranceCentre Hospitalier Universitaire de Rouen (CHU de Rouen) - Hopital Charles-NicolleRecruiting at this site
- Valence, FranceHopital Robert DebreRecruiting at this site
- Villejuif, FranceInstitut Gustave Roussy (IGR) Service de DermatolgieRecruiting at this site
- Berlin, GermanyCharite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) - Klinik fuer Dermatologie Venerologie und Allergologie - Hauttumorcentrum Charite (HTCC)Recruiting at this site
- Bremen, GermanyKlinikum Bremen-Ost gGmbHRecruiting at this site
- Dortmund, GermanyKlinikum Dortmund gGmbH - Klinikzentrum Mitte - HautklinikRecruiting at this site
- Dresden, GermanyUniversitätsklinikum Carl Gustav CarusRecruiting at this site
- Erfurt, GermanyHelios Klinikum Erfurt - Klinik fuer Hautkrankheiten und AllergologieRecruiting at this site
- Erlangen, GermanyUniversitaetsklinikum ErlangenRecruiting at this site
- Essen, GermanyUniversitaetsklinikum EssenRecruiting at this site
- Frankfurt, GermanyJohann Wolfgang Goethe-Universitaet Frankfurt am Main - Klinik fuer Dermatologie, Venerologie und AllergologieRecruiting at this site
- Giessen, GermanyJustus-Liebig-Universitaet Giessen - Klinik fuer Dermatologie und AndrologieRecruiting at this site
- Hamburg, GermanyUniversity of HamburgRecruiting at this site
- Hamburg, GermanyElbe Kliniken Stade - Hautkrebszentrum BuxtehudeRecruiting at this site
- Heidelberg, GermanyUniversitaetsklinikum Heidelberg (UKHD) - HautklinikRecruiting at this site
- Kiel, GermanyUniversity Hospital Schleswig-HolsteinRecruiting at this site
- Leipzig, GermanyUniversitaetsklinikum Leipzig - Klinik fuer Dermatologie, Venerologie und AllergologieRecruiting at this site
- Mainz, GermanyUniversitaetsmedizin der Johannes Gutenberg-Universitaet MainzRecruiting at this site
- Marburg, GermanyUniversitaetsklinikum Giessen und Marburg GmbH - MarburgRecruiting at this site
- Minden, GermanyJohannes Wesling Klinikum MindenRecruiting at this site
In total, worldwide, 201 of the 211 sites listed in the registry are recruiting; the other 10 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: February 25, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 171 more locations
Other identifiers
- 2023-505306-42 · other identifier
- 2023 · NIH grant
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.