Last updated 3 months ago
IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)
680 patients around the world
Available in Spain, Brazil, Argentina, Mexico, United States
Immunocore Ltd
6Research sites
680Patients around the world
This study is for people with
Skin cancer
Melanoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Clínica Adventista Belgrano - CABA - Buenos Aires
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Sanatorio Finochietto
Recruiting
Instituto Americas - COI
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA
Hospital Hispano
StudyPRISM-MEL-301
SponsorImmunocore Ltd
Conditions
Melanoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06112314
