IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)
Trial Status: active
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.
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
Additional locations may be listed on ClinicalTrials.gov for NCT06112314.
Locations matching your search criteria
United States
Arizona
Tucson
Banner University Medical Center - Tucson
Status: Active
Name Not AvailableCalifornia
La Jolla
UC San Diego Moores Cancer Center
Status: Active
Name Not AvailableLos Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Kayla Ghodsi
Phone: 310-794-2971
Email: Ghodsi@mednet.ucla.edu
Los Angeles General Medical Center
Status: Active
Contact: Sandy Tran
Phone: 323-865-3935
Email: sandy.tran@med.usc.edu
USC / Norris Comprehensive Cancer Center
Status: Active
Contact: Sandy Tran
Phone: 323-865-3935
Email: sandy.tran@med.usc.edu
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Name Not AvailableColorado
Aurora
UCHealth University of Colorado Hospital
Status: Active
Contact: Kayla Vondran
Phone: 720-848-9381
Email: kayla.vondran@cuanschutz.edu
District of Columbia
Washington
MedStar Georgetown University Hospital
Status: Active
Name Not AvailableFlorida
Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not AvailableMiami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Name Not AvailableIllinois
Chicago
Northwestern University
Status: Active
Name Not AvailableMassachusetts
Boston
Dana-Farber Cancer Institute
Status: Active
Name Not AvailableBrigham and Women's Hospital
Status: Active
Name Not AvailableNew Jersey
Hackensack
Hackensack University Medical Center
Status: Active
Name Not AvailableOhio
Columbus
Ohio State University Comprehensive Cancer Center
Status: Approved
Name Not AvailablePennsylvania
Philadelphia
Thomas Jefferson University Hospital
Status: Active
Name Not AvailablePittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not AvailableUtah
Salt Lake City
Huntsman Cancer Institute/University of Utah
Status: Active
Name Not AvailableVirginia
Charlottesville
University of Virginia Cancer Center
Status: Active
Name Not AvailableTrial PhasePhase III
Trial Typetreatment
Lead OrganizationImmunocore Limited
- Primary IDIMC-F106C-301
- Secondary IDsNCI-2023-10567, 2023-505306-42, 2023-505306-42-00
- ClinicalTrials.gov IDNCT06112314