Nivolumab + Relatlimab for Advanced Cancer
Trial Summary
What is the purpose of this trial?
The purpose of this study is to evaluate the safety and clinical activity of nivolumab and relatlimab in patients with microsatellite instability high (MSI-H) solid tumors refractory to prior PD-(L)1 therapy.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have had chemotherapy, radiation, or steroids within 14 days before starting the study treatment. It's best to discuss your specific medications with the study team.
What data supports the effectiveness of the drug combination Nivolumab + Relatlimab for advanced cancer?
Research shows that the combination of nivolumab and relatlimab is more effective than nivolumab alone in treating melanoma, a type of skin cancer, especially in patients who have not been treated before. This combination has been approved for use in the USA for treating advanced melanoma, indicating its effectiveness.12345
Is the combination of Nivolumab and Relatlimab safe for humans?
What makes the drug combination of Nivolumab and Relatlimab unique for advanced cancer?
The combination of Nivolumab and Relatlimab is unique because it targets two different immune checkpoints, PD-1 and LAG-3, enhancing the immune system's ability to fight cancer. This dual-target approach is novel and was first approved for treating advanced melanoma, offering a new option for patients with this condition.245910
Research Team
Dung Le, MD
Principal Investigator
Johns Hopkins Medical Institution
Eligibility Criteria
Adults with advanced cancers that have high microsatellite instability and didn't respond to previous PD-1/PD-L1 inhibitor therapy. Participants must be in good physical condition, have at least one measurable lesion, proper organ and marrow function, no severe allergies to monoclonal antibodies or history of certain diseases like interstitial lung disease or brain metastases.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive nivolumab and relatlimab in various dosing regimens for advanced mismatch repair deficient cancers
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
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?
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
Bristol-Myers Squibb
Industry 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
National Cancer Institute (NCI)
Collaborator