Nivolumab + Relatlimab for Melanoma (RELATIVITY-098 Trial)
Palo Alto (17 mi)Age: Any Age
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Bristol-Myers Squibb
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?The purpose of this study is to assess nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.
Eligibility Criteria
Adults and adolescents with completely removed stage III-IV melanoma can join this trial. They must be in good physical condition, not have had prior immunotherapy, or any serious medical issues. People with eye melanoma, brain metastases, recent COVID-19 infection, heart inflammation history, or autoimmune diseases cannot participate.Inclusion Criteria
I am a teenager and can do most activities without help.
I can provide a sample of my tumor for testing.
I am 18 or older and can do all my own self-care.
I've been confirmed disease-free by a recent physical exam and imaging.
I was diagnosed with Stage IIIA/B/C/D or IV melanoma and had surgery to remove it completely.
Exclusion Criteria
I have had myocarditis in the past.
I do not have any serious or uncontrolled medical conditions.
I have an autoimmune disease.
I have had a COVID-19 infection within the last 4 weeks.
I have never received immunotherapy for any cancer.
I have had eye melanoma in the past.
I have brain or spinal cord metastases that haven't been treated or removed.
Treatment Details
The study is testing the effectiveness of combining two drugs (Nivolumab + Relatlimab) versus using Nivolumab alone as a follow-up treatment to prevent melanoma from coming back after surgery.
2Treatment groups
Experimental Treatment
Group I: Arm B: NivolumabExperimental Treatment1 Intervention
Monotherapy
Group II: Arm A: Nivolumab Plus RelatlimabExperimental Treatment1 Intervention
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 InstitutionSan Francisco, CA
Local InstitutionAtlanta, GA
University Of ColoradoAurora, CO
Emory University HospitalAtlanta, GA
More Trial Locations
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Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor