Immunotherapy + Cabozantinib for Advanced Kidney Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, certain medications like immunosuppressive drugs and specific anticoagulants are not allowed. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
What data supports the effectiveness of the drug combination of immunotherapy and cabozantinib for advanced kidney cancer?
Research shows that the combination of cabozantinib and nivolumab is effective for treating advanced kidney cancer, with studies indicating it leads to longer survival and better quality of life compared to some other treatments. This combination is recommended in both European and American guidelines for first-line treatment of advanced renal cancer.12345
Is the combination of immunotherapy and cabozantinib safe for advanced kidney cancer?
How is the drug combination of Ipilimumab, Nivolumab, and Cabozantinib unique for advanced kidney cancer?
This drug combination is unique because it combines immunotherapy (Ipilimumab and Nivolumab) with a targeted therapy (Cabozantinib), which is a tyrosine kinase inhibitor. This approach aims to enhance the immune system's ability to fight cancer while simultaneously targeting specific pathways that help cancer cells grow, offering a potentially more effective treatment for advanced kidney cancer compared to traditional therapies.12345
What is the purpose of this trial?
This phase III trial compares the usual treatment (treatment with ipilimumab and nivolumab followed by nivolumab alone) to treatment with ipilimumab and nivolumab, followed by nivolumab with cabozantinib in patients with untreated renal cell carcinoma that has spread to other parts of the body. The addition of cabozantinib to the usual treatment may make it work better. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known how well the combination of cabozantinib and nivolumab after initial treatment with ipilimumab and nivolumab works in treating patients with renal cell cancer that has spread to other parts of the body.
Research Team
Tian Zhang
Principal Investigator
Alliance for Clinical Trials in Oncology
Eligibility Criteria
This trial is for adults with advanced kidney cancer that hasn't been treated yet. Participants should have a certain level of physical fitness (Karnofsky performance status >= 70%), measurable disease, and be at an intermediate or poor risk according to specific criteria. They can't join if they've had certain treatments before, have active autoimmune diseases, uncontrolled conditions like hypertension or infections like HIV with detectable viral load, or are pregnant.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction
Patients receive nivolumab and ipilimumab intravenously every 21 days for up to 4 cycles
Treatment
Patients receive either nivolumab alone or nivolumab with cabozantinib based on randomization, with treatment repeating every 28 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cabozantinib
- Ipilimumab
- Nivolumab
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?
National Cancer Institute (NCI)
Lead Sponsor