IMC-F106C and Nivolumab for Advanced Melanoma

IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)

Recruiting Phase 3 Interventional Study
Advanced Melanoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
680 (estimated)
Sponsor
Immunocore Ltd · Industry
Who this trial is looking for

This trial is looking for people with advanced melanoma who have not been treated before. Participants will take the treatment IMC-F106C along with nivolumab to see how it works compared to standard nivolumab treatment.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am HLA-A*02:01-positive
  • I have been diagnosed with Stage IV or unresectable Stage III melanoma
  • I have a tumor tissue sample that is confirmed as adequate
  • I have measurable disease according to RECIST 1.1
  • I know my BRAF V600 mutation status
  • My Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1
  • I agree to use effective birth control if I am sexually active and can have children

You may not be able to join if

  • I have a history of another type of cancer
  • I have untreated or active brain tumors or meningitis
  • I am allergic to IMC-F106C, nivolumab, or related drugs
  • I have significant lung disease
  • I have significant heart disease
  • I have active autoimmune disease needing treatment
  • I have a medical condition that might affect my safety or study participation
  • I have received prior systemic cancer treatment for melanoma

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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About This Trial

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.

Trial Locations
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Eligibility Criteria
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 * Part…
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