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.
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
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There are 2 Locations for this study
Greenslopes Queensland, 4120, Australia More Info
Wollstonecraft , , Australia
Woolloongabba , , Australia
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