Sequential Therapy for Kidney Cancer
Trial Summary
What is the purpose of this trial?
This is a pilot, single-center, single-arm study where 20 patients with metastatic or unresectable clear cell renal cell carcinoma will receive same sequential treatment strategy (Cabozantinib for 12 weeks, then proceed with Ipilimumab plus Nivolumab immunotherapy x4 over 12 weeks, then subsequent therapies depending on treatment response for another 12 weeks \[Nivolumab for CR/PR/SD, Cabozantinib or Lenvatinib/Everolimus for PROG\]).
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 have received certain cancer treatments or immunosuppressive medications recently, and some anticoagulants are not allowed. It's best to discuss your specific medications with the trial team.
What evidence supports the effectiveness of the drug combination used in the Sequential Therapy for Kidney Cancer trial?
Research shows that the combination of cabozantinib and nivolumab is effective for advanced kidney cancer, leading to longer survival and better quality of life compared to other treatments. Additionally, combining nivolumab with ipilimumab has shown improved survival rates and response in patients with certain risk profiles.12345
Is the sequential therapy for kidney cancer safe for humans?
The combination of cabozantinib and nivolumab, sometimes with ipilimumab, 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, and fatigue can occur, but they can often be managed with supportive care and dose adjustments.26789
How is the drug combination of Cabozantinib, Ipilimumab, and Nivolumab unique for treating kidney cancer?
This drug combination is unique because it combines a tyrosine kinase inhibitor (Cabozantinib) with two immune checkpoint inhibitors (Nivolumab and Ipilimumab), offering a novel approach that may enhance the immune system's ability to fight cancer and improve outcomes compared to traditional treatments. The combination has shown promise in clinical trials, potentially leading to longer disease control and improved survival for patients with advanced kidney cancer.2451011
Eligibility Criteria
Adults with advanced or metastatic clear cell renal cell carcinoma that can't be surgically removed. They should have a life expectancy of at least 12 weeks, measurable disease, and good organ function. Participants must not be pregnant, have had certain cancers within the last 3 years, or received specific treatments for kidney cancer before.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment - Cabozantinib
Participants receive Cabozantinib for 12 weeks
Treatment - Ipilimumab + Nivolumab
Participants receive Ipilimumab plus Nivolumab immunotherapy for 12 weeks
Treatment - Response-based
Participants receive Nivolumab for CR/PR/SD, or Cabozantinib or Lenvatinib/Everolimus for PROG for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cabozantinib (Tyrosine Kinase Inhibitor)
- Everolimus (mTOR Inhibitor)
- Ipilimumab (Checkpoint Inhibitor)
- Lenvatinib (Tyrosine Kinase Inhibitor)
- Nivolumab (Checkpoint Inhibitor)
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