Nivolumab + Relatlimab for Melanoma
(RELATIVITY-098 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether combining two treatments, nivolumab (an immunotherapy drug also known as Opdivo) and relatlimab (an immunotherapy drug also known as Opdualag), proves more effective than nivolumab alone for individuals who have undergone surgery to remove stage III or IV melanoma. Melanoma is a serious type of skin cancer. The trial seeks to determine if the combination can prevent the cancer from returning. To qualify, participants must have had their melanoma completely removed and show no signs of disease. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it does exclude participants with certain medical conditions and those who have had prior immunotherapy treatments.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of nivolumab and relatlimab is generally well-tolerated by patients with melanoma. The side effects observed in studies align with those already known for these drugs, indicating no unexpected side effects beyond those typically associated with each drug individually.
Nivolumab alone has already received FDA approval for treating melanoma, suggesting a strong safety record. Studies have found no new safety issues, supporting its continued use.
In summary, both the combination of nivolumab and relatlimab, and nivolumab alone, have demonstrated manageable side effects in previous studies. These findings may reassure participants considering joining the trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about combining Nivolumab and Relatlimab for melanoma treatment because this duo brings a fresh approach to the table. Unlike traditional treatments that typically focus on one immune checkpoint, this combination targets two: PD-1 with Nivolumab and LAG-3 with Relatlimab. This dual-action strategy aims to unleash a more robust immune response against melanoma cells, potentially leading to better outcomes. Additionally, while Nivolumab alone is already a standard option, adding Relatlimab might enhance its effectiveness, offering new hope for patients with advanced melanoma.
What evidence suggests that this trial's treatments could be effective for melanoma?
Research shows that using nivolumab with relatlimab, which participants in this trial may receive, holds promise for treating melanoma, a type of skin cancer. Patients on this combination have experienced longer periods without cancer growth or spread compared to those on nivolumab alone. Specifically, studies found that this combination can control cancer for about six months longer. Nivolumab alone, another treatment option in this trial, also proves beneficial, with 44% of advanced melanoma patients surviving for five years. This suggests both treatments can be effective, but the combination might offer additional benefits.46789
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either nivolumab plus relatlimab fixed-dose combination or nivolumab monotherapy after complete resection of melanoma
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nivolumab
- Relatlimab
Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:
- 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
- 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
- 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
- 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
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