Clinical trial · Interventional
IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)
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
NCT06112314CI-TRIAL-00104056PRISM-MEL-301recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brenetafusp | Drug | — | UNRESOLVED |
| Nivolumab | Drug | Nivolumab | ALIAS |
| Nivolumab + Relatlimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A: Brenetafusp Low Dose + Nivolumab
- description
- Participants receive brenetafusp Low Dose once weekly (QW) for the first 13 weeks, then every 2 weeks (Q2W) through Week 51, and then every 4 weeks (Q4W). Nivolumab is given Q4W. Closed to randomization after dose recommendation by the IDMC in November 2025.
- interventionNames
- Drug: Brenetafusp
- Drug: Nivolumab
- type
- EXPERIMENTAL
- label
- Arm B: Brenetafusp High Dose + Nivolumab
- description
- Participants receive brenetafusp High Dose once weekly (QW) for the first 13 weeks, then every 2 weeks (Q2W) through Week 51, and then every 4 weeks (Q4W). Nivolumab is given Q4W. Selected as go-forward experimental arm after dose recommendation by the IDMC in November 2025
- interventionNames
- Drug: Brenetafusp
- Drug: Nivolumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.