A PHASE 3 RANDOMIZED, CONTROLLED STUDY OF IMC-F106C PLUS NIVOLUMAB VS NIVOLUMAB REGIMENS IN HLA-A*02:01 POSITIVE PARTICIPANTS WITH PREVIOUSLY UNTREATED ADVANCED MELANOMA (PRISM-MEL-301)
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.
Main Inclusion/Exclusion:
- MUST be HLA-A*02:01 positive (testing by central laboratory)
- ECOG 0 or 1
- Participants must have measurable disease per RECIST 1.1
- Participants must have histologically confirmed Stage IV OR unresectable Stage III melanoma
- Participants who received prior systemic therapy for unresectable or metastatic melanoma: Prior neoadjuvant and adjuvant melanoma therapies are allowed if: Related AEs are stable or returned to baseline AND at least 6-month interval between date of recurrence and last dose of anti-PD-(L)1, anti-CTLA-4, anti-LAG-3, BRAF inhibitor, or MEK inhibitor containing regimens
Indications:
- Previously Untreated, advanced (unresectable or metastatic) melanoma
Contact: cajwciclinicaltrials@providence.org