Melanoma Clinical Trial

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

Summary

This is a phase 3, randomized, controlled study of IMC-F106C plus nivolumab compared to standard nivolumab regimens in HLA-A*02:01-positive participants with previously untreated advanced melanoma.

View Eligibility Criteria

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
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 is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

680

Study ID:

NCT06112314

Recruitment Status:

Recruiting

Sponsor:

Immunocore Ltd

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There is 1 Location for this study

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Prisma Health Cancer Institute
Greenville South Carolina, 29605, United States
University of Sydney - Melanoma Institute Australia (MIA) - The Poche Centre
Wollstonecraft , , Australia
The University of Queensland (UQ) - Princess Alexandra Hospital (PAH)
Woolloongabba , , Australia

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

680

Study ID:

NCT06112314

Recruitment Status:

Recruiting

Sponsor:


Immunocore Ltd

How clear is this clinincal trial information?

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