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

Immunocore

Status and phase: Enrolling; Phase 3

Conditions: Advanced Melanoma

Treatments: Biological: Brenetafusp; Biological: Nivolumab + Relatlimab; Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06112314

2023-505306-42-00 (Other Identifier)

IMC-F106C-301

Details and patient eligibility

About

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.

Enrollment: 680 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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680 participants in 3 patient groups

Arm A: Brenetafusp Low Dose + Nivolumab

Experimental group

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.

Treatment:

Biological: Nivolumab

Biological: Brenetafusp

Arm B: Brenetafusp High Dose + Nivolumab

Experimental group

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.

Treatment:

Biological: Nivolumab

Biological: Brenetafusp

Arm C: Nivolumab OR Nivolumab + Relatlimab

Active Comparator group

Description:

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

Treatment:

Biological: Nivolumab + Relatlimab

Biological: Nivolumab