Nivolumab with Surgery for Kidney Cancer
(PROSPER Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must not be on any systemic treatment with corticosteroids or other immunosuppressive medications, except for certain exceptions like topical or inhaled steroids. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug Nivolumab with surgery for kidney cancer?
Research shows that Nivolumab, when used before surgery, is safe and feasible for patients with localized kidney cancer, allowing them to proceed with surgery without significant delays. Additionally, there are cases where Nivolumab has led to a complete response in patients with advanced kidney cancer, reducing tumor size and making surgery less invasive.12345
Is nivolumab safe for use in kidney cancer treatment?
How does the drug nivolumab with surgery differ from other treatments for kidney cancer?
Nivolumab, an immune checkpoint inhibitor, is unique because it is used before surgery (nephrectomy) to potentially shrink kidney tumors and improve surgical outcomes, which is not a common approach for localized kidney cancer. This combination aims to enhance the body's immune response against cancer cells, offering a novel strategy compared to traditional treatments that typically involve surgery alone.123410
What is the purpose of this trial?
This phase III trial compares nephrectomy (surgery to remove a kidney or part of a kidney) with nivolumab to the usual approach of nephrectomy followed by standard post-operative follow-up and monitoring, in treating patients with kidney cancer that is limited to a certain part of the body (localized). Nivolumab is a drug that may help stimulate the immune system to attack any cancer cells that may remain after surgery. The addition of nivolumab to the usual surgery could prevent the cancer from returning. It is not yet known whether nivolumab and nephrectomy is more effective than nephrectomy alone in treating patients with kidney cancer.
Research Team
Lauren Harshman
Principal Investigator
ECOG-ACRIN Cancer Research Group
Eligibility Criteria
Adults with localized kidney cancer (stage T2 or higher, without distant metastases) who are planning to have a kidney removed and haven't had prior cancer treatments. Participants should not have serious illnesses, active infections needing IV antibiotics, HIV, or be on high-dose steroids. They must not be pregnant/breastfeeding and agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive nivolumab intravenously and undergo partial or radical nephrectomy
Follow-up
Participants are monitored for recurrence-free survival and overall survival
Treatment Details
Interventions
- Nephrectomy
- Nivolumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Canadian Cancer Trials Group
Collaborator