Immunotherapy for Kidney Cancer
Trial Summary
What is the purpose of this trial?
This randomized pilot early phase I trial studies the side effects and how well nivolumab alone works compared to nivolumab with bevacizumab or ipilimumab before surgery in treating patients with kidney cancer, also referred to as renal cell cancer, that has spread to another place in body and can be removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, bevacizumab, 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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, patients on high-dose steroids or other potent immune suppression medications, as well as those requiring ongoing anticoagulation (except aspirin), are excluded. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug Nivolumab for kidney cancer?
What safety data exists for immunotherapy treatments like Nivolumab and Ipilimumab in kidney cancer?
Immunotherapy treatments like Nivolumab and Ipilimumab can cause immune-related side effects, which may affect various organs. Common side effects include inflammation of the colon, liver, skin, and thyroid, while rare but serious effects can include heart and lung inflammation. These treatments have been studied in kidney cancer and other conditions, showing a need for careful monitoring of these side effects.678910
How is the drug Nivolumab unique in treating kidney cancer?
Nivolumab is unique because it is an immune checkpoint inhibitor that helps the body's immune system attack cancer cells, specifically targeting the PD-1 pathway. It has shown a survival advantage in patients with advanced kidney cancer who have already received other treatments, offering a new option after anti-angiogenic therapy.411121314
Research Team
Padmanee Sharma, MD, PhD
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for adults with metastatic clear cell renal cell carcinoma (kidney cancer) that can be surgically removed. Participants must understand the study and risks, may have had previous treatments except certain immunotherapies or bevacizumab, and should meet specific health criteria like adequate blood counts and organ function.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive nivolumab alone or in combination with bevacizumab or ipilimumab for 6 weeks, followed by surgery
Surgery
Patients undergo nephrectomy, metastasectomy, or biopsy approximately 4 weeks after treatment
Maintenance Therapy
Patients receive maintenance nivolumab every 4 weeks for up to 2 years if they have a clinical response or stable disease
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Bevacizumab
- Ipilimumab
- Nivolumab
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?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator