Nivolumab + Relatlimab + Ipilimumab for Renal Cell Carcinoma
Trial Summary
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot be on certain treatments like corticosteroids above a specific dose or other immunosuppressive medications within 14 days before starting the trial.
What data supports the effectiveness of the drug combination Nivolumab, Relatlimab, and Ipilimumab for treating renal cell carcinoma?
Research shows that the combination of Nivolumab and Ipilimumab is effective for treating advanced renal cell carcinoma, with studies demonstrating improved survival rates compared to other treatments. This combination has been approved for use in patients with intermediate or poor-risk advanced renal cell carcinoma.12345
Is the combination of Nivolumab, Relatlimab, and Ipilimumab safe for treating renal cell carcinoma?
The combination of Nivolumab and Ipilimumab has been studied for safety in renal cell carcinoma, showing manageable safety with some patients experiencing serious side effects. Common side effects include immune-related adverse events, which can be serious but are often manageable with medical care.678910
How is the drug combination of Nivolumab, Relatlimab, and Ipilimumab unique for treating renal cell carcinoma?
This drug combination is unique because it combines three immune checkpoint inhibitors, which work by helping the immune system recognize and attack cancer cells more effectively. Nivolumab and Ipilimumab have already shown improved survival rates in advanced renal cell carcinoma compared to traditional treatments, and the addition of Relatlimab may enhance this effect further.12111213
What is the purpose of this trial?
This is a phase 2 stratified, randomized, multicenter, study investigating the efficacy of a triplet arm treating with nivolumab 480 mg every 4 weeks (Q4W), relatlimab 160 mg Q4W and ipilimumab 1 mg/kg every 8 weeks (Q8W) intravenous (IV) versus a doublet arm treating with nivolumab 480 mg Q3W and ipilimumab 1mg/kg Q3W IV in first-line advanced RCC.
Research Team
Eric Jonasch, MD
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for adults with advanced kidney cancer (Renal Cell Carcinoma) who haven't had treatment before. Participants should be fit enough for the treatments and not have any health conditions that could interfere with the study or their safety.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Nivolumab + Ipilimumab or Nivolumab + Relatlimab + Ipilimumab on an outpatient basis
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ipilimumab
- Nivolumab
- Relatlimab
Ipilimumab is already approved in United States, European Union for the following indications:
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
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