Subcutaneous Nivolumab + Relatlimab for Melanoma
(RELATIVITY-127 Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial requires that participants do not take systemic corticosteroids or other immunosuppressive medications within 14 days before starting the study treatment. Inhaled or topical steroids are allowed if you don't have an active autoimmune disease.
Will I have to stop taking my current medications?
The trial requires that you stop taking systemic corticosteroids or other immunosuppressive medications at least 14 days before starting the study treatment. However, inhaled or topical steroids and certain adrenal replacement doses are allowed.
What data supports the effectiveness of the drug Nivolumab + Relatlimab for melanoma?
What data supports the effectiveness of the drug Nivolumab + Relatlimab for melanoma?
Is the combination of Nivolumab and Relatlimab safe for treating melanoma?
Is the combination of Nivolumab and Relatlimab safe for treating melanoma?
What makes the drug Nivolumab + Relatlimab unique for treating melanoma?
Nivolumab + Relatlimab is unique because it combines two immunotherapy drugs that target different immune checkpoints, PD-1 and LAG-3, to enhance the body's immune response against melanoma. This fixed-dose combination has shown improved progression-free survival in patients with unresectable or metastatic melanoma compared to nivolumab alone.12369
What makes the drug Nivolumab + Relatlimab unique for treating melanoma?
Nivolumab + Relatlimab is unique because it combines two immunotherapy drugs that target different immune checkpoints, PD-1 and LAG-3, to enhance the body's immune response against melanoma. This fixed-dose combination has shown improved progression-free survival compared to nivolumab alone in patients with unresectable or metastatic melanoma.12369
What is the purpose of this trial?
This trial is testing two ways of giving a combination of two drugs, nivolumab and relatlimab, to patients with advanced melanoma that hasn't been treated before. One method involves injecting the drugs under the skin, while the other involves injecting them into a vein. These drugs help the immune system recognize and attack cancer cells.
Research Team
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Eligibility Criteria
This trial is for people aged 12 and older with Stage III (unresectable) or Stage IV (metastatic) melanoma, as per AJCC staging. They must have measurable disease by CT or MRI, be in good physical condition (ECOG ≤1), and adolescents must weigh at least 40 kg. It's not for those with ocular melanoma, a history of myocarditis, or on high-dose steroids/immunosuppressants.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either subcutaneous or intravenous administration of nivolumab + relatlimab FDC
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Nivolumab + Relatlimab Fixed-dose Combination (FDC)
Nivolumab + Relatlimab Fixed-dose Combination (FDC) is already approved in United States for the following indications:
- Advanced melanoma (unresectable or metastatic)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania