IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)
Recruiting · NCT06112314 · Interventional (participants receive a specific treatment) · Lead sponsor: Immunocore Ltd
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 23 US states.
- University of Arizona - Tucson, Arizona, United States
- University of California - San Diego - La Jolla, California, United States
- The Angeles Clinic and Research Institute- West Los Angeles - Los Angeles, California, United States
- ESC Norris Comprehensive Cancer Center - Los Angeles, California, United States
- UCLA Hematology/Oncology - Los Angeles, California, United States
- Stanford Cancer Institute - Stanford Cancer Center Palo Alto - Palo Alto, California, United States
- Saint John's Health Center - John Wayne Cancer Institute (JWCI) - Santa Monica, California, United States
- University of Colorado, Anschutz Medical Campus - Aurora, Colorado, United States
- The Melanoma & Skin Cancer Institute - Denver, Colorado, United States
- UConn Health-Farmington (University of Connecticut Health Center (UCHC)) - Farmington, Connecticut, United States
- Georgetown University - Washington D.C., District of Columbia, United States
- Mayo Clinic Florida - Jacksonville, Florida, United States
- University of Miami Health System-Sylvester Comprehensive Cancer Center-Miami - Miami, Florida, United States
- Northwestern University - Robert H. Lurie Comprehensive Cancer Center - NMDTI - Chicago, Illinois, United States
- The University of Kansas Cancer Center (KUCC) - Westwood - Westwood, Kansas, United States
- St. Elizabeth Healthcare - Edgewood - Edgewood, Kentucky, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Dana Farber Cancer Institute - Boston, Massachusetts, United States
- Henry Ford Cancer Center - Michigan - Detroit, Michigan, United States
- Allina Health Cancer Institute - Minneapolis - Minneapolis, Minnesota, United States
- Washington University School of Medicine - St Louis, Missouri, United States
- John Theurer Cancer Center at Hackensack University Medical Center - Hackensack, New Jersey, United States
- Northwell Health Cancer Institute - Lake Success, New York, United States
- Columbia University Medical Center - New York, New York, United States
- The Ohio State University - Columbus, Ohio, United States
- Thomas Jefferson University - Philadelphia, Pennsylvania, United States
- UPMC Hillman Cancer Center - Pittsburgh, Pennsylvania, United States
- Prisma Health Cancer Institute - Greenville, South Carolina, United States
- Spartanburg Regional Healthcare System - Spartanburg Medical Center (SMC) - Spartanburg, South Carolina, United States
- The University of Tennessee - Knoxville (UTK) - Knoxville, Tennessee, United States
- Sarah Cannon Research Institute: USA/TN - Nashville, Tennessee, United States
- Tennessee Oncology, PLLC - Nashville, Tennessee, United States
- University of Texas Southwestern - Dallas, Texas, United States
- University of Utah Huntsman Cancer Institute - Salt Lake City, Utah, United States
- UVA Health-UVA Emily Couric Clinical Cancer Center - Charlottesville, Virginia, United States
- Virginia Commonwealth University (VCU) - Massey Cancer Center - Richmond, Virginia, United States
- Swedish Medical Center - Swedish Cancer Institute (SCI) - First Hill Campus - Seattle, Washington, United States
- Complejo Hospitalario Universitario A Coruna (CHUAC) - A Coruña, Spain
- Kanser Enstitusu (Hacettepe University Cancer Institute) - Altındağ, Turkey (Türkiye)
- Universite Libre de Bruxelles (ULB)-Institut Jules Bordet - Anderlecht, Belgium
- T.C. Saglik Bakanligi - SBU Gulhane Egitim ve Arastirma Hastanesi - Ankara, Turkey (Türkiye)
- Hospital Universitari Vall d'Hebron - Barcelona, Spain
- Hospital Universitario Dexeus - Barcelona, Spain
- Hospital Duran i Reynals - Barcelona, Spain
- Hospital Clinic de Barcelona - Barcelona, Spain
- Istituto Tumori Giovanni Paolo II - Ospedale Oncologico di Bari - Bari, Italy
- Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de Amor - Barretos, Brazil
- Humanitas Gavazzeni (Cliniche Gavazzeni S.p.A) - Bergamo, Italy
- Haukeland University Hospital - Bergen, Norway
- Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) - Klinik fuer Dermatologie Venerologie und Allergologie - Hauttumorcentrum Charite (HTCC) - Berlin, Germany
- Queen Elizabeth Hospital Birmingham - Birmingham, United Kingdom
- Assistance Publique-Hopitaux de Paris (AP-HP) - Hopitaux Universitaires Paris Seine-Saint-Denis - Hopital Avicenne - Bobigny, France
- Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Ambroise-Pare - Boulogne-Billancourt, France
- Hospital Sirio-Libanes (HSL) - Centro de Oncologia - Brasilia - Brasília, Brazil
- Klinikum Bremen-Ost gGmbH - Bremen, Germany
- AZ Sint-Jan Brugge-Oostende AV-Campus Sint-Jan - Bruges, Belgium
- Universitair Ziekenhuis Brussel - Brussels, Belgium
- Cliniques Universitaires Saint-Luc - Institut Roi Albert II - Brussels, Belgium
- Semmelweis Egyetem Általános Orvostudományi Kar - Budapest, Hungary
- Orszagos Onkologiai Intezet (National Institute of Oncology) - Budapest, Hungary
Showing 60 of 211 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →