Relatlimab + Nivolumab for Advanced Melanoma
(RELATIVITY-047 Trial)
Recruiting in Palo Alto (17 mi)
+259 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Waitlist Available
Sponsor: Bristol-Myers Squibb
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?
This trial is testing if using two medications together (relatlimab and nivolumab) is better than using just one (nivolumab) for treating a type of skin cancer that can't be removed by surgery or has spread. The drugs help the immune system to better recognize and attack cancer cells.
Eligibility Criteria
This trial is for individuals with advanced melanoma that can't be removed by surgery or has spread, and who haven't had previous systemic cancer treatments. They must have a confirmed diagnosis of Stage III (unresectable) or Stage IV melanoma and provide tumor tissue for analysis. People with active brain metastases, uveal melanoma, or autoimmune diseases cannot participate.Inclusion Criteria
My melanoma is at an advanced stage and cannot be surgically removed.
I have not received systemic anticancer therapy for my advanced melanoma.
I can provide a tissue sample from my cancer that cannot be surgically removed.
Exclusion Criteria
I do not have cancer that has spread to my brain or its coverings.
I do not have eye melanoma.
I do not have any known autoimmune diseases.
Treatment Details
Interventions
- Nivolumab (Checkpoint Inhibitor)
- Relatlimab (Checkpoint Inhibitor)
Trial OverviewThe study is testing the effectiveness of combining two drugs: Relatlimab and Nivolumab versus using Nivolumab alone in treating advanced melanoma. The goal is to see if the combination works better than just one drug on its own.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Arm B: NivolumabExperimental Treatment1 Intervention
Monotherapy
Group II: Arm A: Relatlimab + NivolumabExperimental Treatment2 Interventions
Combination
Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:
🇺🇸 Approved in United States as Opdivo for:
- Advanced or metastatic gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Hepatocellular carcinoma
- Esophageal squamous cell carcinoma
🇪🇺 Approved in European Union as Opdivo for:
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
🇨🇦 Approved in Canada as Opdivo for:
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
🇨🇭 Approved in Switzerland as Opdivo for:
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Local Institution - 0068Ottawa, Canada
Beth Israel Deaconess Medical CenterBoston, MA
Local Institution - 0018Charlotte, NC
Local Institution - 0015Ann Arbor, MI
More Trial Locations
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Who Is Running the Clinical Trial?
Bristol-Myers SquibbLead Sponsor