Condition: Advanced Melanoma · Sponsor: Immunocore Ltd
Interested? Contact the study team ↓
Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
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.
This description comes directly from the study's public registry record.
Immunocore Medical Information · 844-466-8661 · medical.information@immunocore.com
Immunocore Medical Information EU · +00 800-744-51111 · medinfo.eu@immunocore.com
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| University of Arizona | Tucson, Arizona, United States | Recruiting |
| University of California - San Diego | La Jolla, California, United States | Recruiting |
| The Angeles Clinic and Research Institute- West Los Angeles | Los Angeles, California, United States | Recruiting |
| ESC Norris Comprehensive Cancer Center | Los Angeles, California, United States | Recruiting |
| UCLA Hematology/Oncology | Los Angeles, California, United States | Recruiting |
| Stanford Cancer Institute - Stanford Cancer Center Palo Alto | Palo Alto, California, United States | Completed |
| Saint John's Health Center - John Wayne Cancer Institute (JWCI) | Santa Monica, California, United States | Recruiting |
| University of Colorado, Anschutz Medical Campus | Aurora, Colorado, United States | Recruiting |
| The Melanoma & Skin Cancer Institute | Denver, Colorado, United States | Recruiting |
| UConn Health-Farmington (University of Connecticut Health Center (UCHC)) | Farmington, Connecticut, United States | Completed |
| Georgetown University | Washington D.C., District of Columbia, United States | Recruiting |
| Mayo Clinic Florida | Jacksonville, Florida, United States | Recruiting |
+ 199 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice. By subscribing you agree to our Terms of Use and Privacy Policy.