IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)
ConditionAdvanced Melanoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorImmunocore Ltd
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Brenetafusp
- Nivolumab
- Nivolumab + Relatlimab
Treatment groups
680 Participants
are divided into 3 treatment groupsLocations
211Argentina
Clínica Adventista Belgrano - Sector InvestigaciónC1430EGF, CabaBuenos Aires, Argentina
Sanatorio Finochietto1213, CabaBuenos Aires, Argentina
Hospital Italiano de Buenos Aires (HIBA)C1199ABD, Buenos Aires Argentina
Instituto Alexander FlemingCP1426ANZ, CABA Argentina
Sponsors and collaborators
Immunocore Ltd
Lead sponsor
Source ClinicalTrials.gov