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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Brenetafusp
    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.
    Other names:
    • IMC-F106C
  • Drug: Nivolumab
    Concentrate for solution for infusion at a unit dose of 10 mg/mL.
    Other names:
    • OPDIVO
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.
  • Drug: Brenetafusp
    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.
    Other names:
    • IMC-F106C
  • Drug: Nivolumab
    Concentrate for solution for infusion at a unit dose of 10 mg/mL.
    Other names:
    • OPDIVO
Active Comparator
Arm C: Nivolumab OR Nivolumab + Relatlimab 		Participants receive nivolumab 480 mg monotherapy, or nivolumab 480 mg + relatlimab 160 mg, Q4W.
  • Drug: Nivolumab
    Concentrate for solution for infusion at a unit dose of 10 mg/mL.
    Other names:
    • OPDIVO
  • Drug: Nivolumab + Relatlimab
    Concentrate for solution for infusion at a unit dose of 16 mg/mL.
    Other names:
    • OPDUALAG

Recruiting Locations

The University of Kansas Cancer Center (KUCC) - Westwood
Westwood, Kansas 66205
Contact:
CT Nurse Navigator
913-945-7552
CTNurseNav@kumc.edu

More Details

Status
Recruiting
Sponsor
Immunocore Ltd

Study Contact

Immunocore Medical Information
844-466-8661
medical.information@immunocore.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.