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

Conditions

• Advanced Melanoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Brenetafusp — DRUG
  Soluble PRAME-specific T cell receptor with anti-CD3 scFV concentrate for solution for intravenous (IV) infusion at a unit dose of 0.2 mg/mL.
• Nivolumab — DRUG
  Concentrate for solution for infusion at a unit dose of 10 mg/mL.
• Nivolumab + Relatlimab — DRUG
  Concentrate for solution for infusion at a unit dose of 16 mg/mL.

Study Details

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.

Key Dates

Start date

Jun 5, 2024

Status verified

Feb 2026

Primary completion

Oct 16, 2027

Completion

Oct 16, 2027

Study Design

Enrollment

680 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Brenetafusp Low Dose + Nivolumab
  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.
• Experimental: Arm B: Brenetafusp High Dose + Nivolumab
  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
• Active Comparator: Arm C: Nivolumab OR Nivolumab + Relatlimab
  Participants receive nivolumab 480 mg monotherapy, or nivolumab 480 mg + relatlimab 160 mg, Q4W.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to ~45 months ]

Central Contacts

• Immunocore Medical Information
  844-466-8661
  [email protected]
• Immunocore Medical Information EU
  +00 800-744-51111
  [email protected]

Locations (37)

Find similar trials in Tucson, AZ

Related Studies

• A Trial of Pembrolizumab and Metformin Versus Pembrolizumab Alone in Advanced Melanoma
  PHASE1 · Recruiting · Yana Najjar · Pittsburgh, Pennsylvania
• IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors
  PHASE1 · Recruiting · M.D. Anderson Cancer Center · Houston, Texas
• Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
  PHASE3 · Recruiting · Immunocore Ltd · Phoenix, Arizona
• Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on Checkpoint Inhibitors
  PHASE1 · Recruiting · Washington University School of Medicine · St Louis, Missouri