Brief Summary
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 advancedat a late stage, far along melanomaa type of cancer that develops from melanocytes, which are the cells that produce pigment generally in the skin (but can develop in other areas of the body).
Intervention / Treatment
- Biological: Brenetafusp
- Biological: Nivolumab
- Biological: Nivolumab + Relatlimab
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 tissuea group of cells that work together to perform a function 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 Oncologythe study, diagnosis and treatment of cancer 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 screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening date until 5 months after the final dosethe amount of medication taken of study intervention.