Cabozantinib + Immunotherapy for Kidney Cancer
(COSMIC-313 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a multicenter, randomized, double-blinded, controlled Phase 3 trial of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in combination with matched placebo. Approximately 840 eligible subjects with intermediate- or poor-risk advanced or metastatic RCC by IMDC criteria will be randomized in a 1:1 ratio at approximately 180 sites.
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 participate if you are on certain treatments like systemic anticancer therapy, oral anticoagulants, or immunosuppressive medications. It's best to discuss your specific medications with the trial team.
Is the combination of Cabozantinib and Nivolumab safe for treating kidney cancer?
The combination of Cabozantinib and Nivolumab has been studied for safety in treating advanced kidney cancer. While the safety profile is generally manageable, some side effects like diarrhea, liver issues, skin reactions, fatigue, and kidney problems can occur. Managing these side effects with supportive care and dose adjustments is important to maintain treatment tolerability.12345
How is the drug combination of Cabozantinib, Ipilimumab, and Nivolumab unique for kidney cancer?
This drug combination is unique because it combines a targeted therapy (Cabozantinib) with two immunotherapies (Nivolumab and Ipilimumab), aiming to enhance the immune system's ability to fight kidney cancer while also targeting cancer cell growth. It is recommended for first-line treatment of advanced renal cancer and has shown effectiveness in improving progression-free survival compared to some other drug combinations.12456
What data supports the effectiveness of the drug combination of Cabozantinib, Nivolumab, and Ipilimumab for kidney cancer?
Research shows that the combination of Cabozantinib and Nivolumab is effective for treating advanced kidney cancer, as it was found to be better than some other drug combinations in terms of survival and slowing disease progression. This combination is recommended in the latest treatment guidelines for advanced kidney cancer.12567
Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic kidney cancer that hasn't been treated before. They should have a certain level of fitness (KPS ≥ 70%) and measurable disease. People can't join if they've had recent surgeries, live vaccines, other cancers within 3 years, autoimmune diseases needing treatment in the last two years, or are on high-dose steroids.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cabozantinib in combination with nivolumab and ipilimumab or nivolumab and ipilimumab with placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cabozantinib
- Ipilimumab
- Nivolumab
Cabozantinib is already approved in European Union, United States, Canada, Japan for the following indications:
- Renal cell carcinoma
- Hepatocellular carcinoma
- Renal cell carcinoma
- Hepatocellular carcinoma
- Renal cell carcinoma
- Hepatocellular carcinoma
- Renal cell carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Exelixis
Lead Sponsor
Michael M. Morrissey
Exelixis
Chief Executive Officer since 2010
PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin
Vicki L. Goodman
Exelixis
Chief Medical Officer since 2022
MD