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Taking people in MexicoPhase 3

Tests brenetafusp with nivolumab against standard nivolumab treatments in advanced melanoma

Tests brenetafusp plus nivolumab in adults with untreated advanced melanoma.

Key facts

Who runs it
Immunocore Ltd
Where
Guadalajara and Mexico City, MexicoSee the 2 sitesAlso in 25 other countries, 208 sites
Registry title
IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)
Status
Recruiting
Phase
Phase 3
People taking part
680 people, planned
Started
5 Jun 2024
Expected to end
16 Oct 2027
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Brenetafusp
  • Nivolumab
  • Nivolumab + Relatlimab
Record updated
25 February 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Mexico

Also in 25 other countries, 208 sites

  • Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"Guadalajara, MexicoTaking people
  • Centro Oncologico Internacional(COI) - Ciudad de MexicoMexico City, MexicoTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Arm A: Brenetafusp Low Dose + NivolumabTreatment being tested

    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.

    Treatment: Brenetafusp and Nivolumab

  • Arm B: Brenetafusp High Dose + NivolumabTreatment being tested

    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

    Treatment: Brenetafusp and Nivolumab

  • Arm C: Nivolumab OR Nivolumab + RelatlimabExisting treatment, for comparison

    Participants receive nivolumab 480 mg monotherapy, or nivolumab 480 mg + relatlimab 160 mg, Q4W.

    Treatment: Nivolumab and Nivolumab + Relatlimab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Tests brenetafusp with nivolumab against standard nivolumab treatments in advanced melanomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
25 February 2026