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Perioperative nivolumab in locally advanced renal cell carcinoma RCC

 Phase 3; 805 patients 
 Last updated: December 14, 2018
 STATUS: Recruiting (accepting new patients) (perClinicalTrials.gov/NCT03055013)


is the trial for?

Patients with kidney cancer (Renal cell carcinoma, RCC) who currently meet the following criteria:
  • clinical stage 2 or greater (7cm renal mass or greater)
  • localised disease with high risk of recurrence
    including patients with bilateral disease (both kidneys)
    including patients with 3 or fewer metastases (except liver or bone metastases) that are resectable or can be managed by thermal ablation (e.g. cryoablation or radiofrequency ablation) or radiation
  • all subtypes/histologies permitted, including sarcomatoid


is the key question that this trial is attempting to answer?

This phase 3 study seeks to evaluate whether nivolumab and nephrectomy is more effective than nephrectomy alone in treating patients with kidney cancer. It investigates whether the immune-checkpoint inhibitor nivolumab given both before and after nephrectomy is more effective than nephrectomy alone followed by close observation.


patients might want to participate?

This clinical trial offers patients an opportunity to access a new therapy that may be effective for kidney cancer. This trial will further support the research in kidney cancer and potentially help other patients with kidney cancer. The trial might or might not have benefit in your individual case. For more about the importance and benefits of joining clinical trials, please click here.


will the trial be open?

The study is open (currently recruiting) – 805 patients worldwide are currently expected to participate.


is the trial available?

The trial will be available in various cancer centers worldwide.
For a complete list of trial locations, please click here:



What does the study look like?

There will be 2 study arms (groups): all participating patients will be randomly divided (by a computer) into two groups. Note: patients in the second group will receive no treatment other than surgery (surgery alone is the current standard of care) but will be closely observed.

Patients in group 1 (only) will first receive a biopsy to confirm the diagnosis of RCC, and then will be treated with nivolumab (Opdivo™) before and after surgery. Patients in group 2 will have surgery and will be closely observed. A biopsy is encouraged but not required in patients in group 2.

PROSPER new 500
1) Patients in group 1 will first have their diagnosis of RCC confirmed with a biopsy. If confirmed as RCC, patients will receive 1 dose of nivolumab intravenously. After surgery (resection of the tumour), the patient will receive an infusion of nivolumab every 4 weeks for 9 months. The immune-oncology medication nivolumab (Opdivo™) is a fully human monoclonal antibody targeting PD-1 that is approved for advanced or metastatic kidney cancer.
2) Patients in group 2 will not require a biopsy. These patients will have the surgery (resection of the tumour, either radical or partial nephrectomy as indicated) followed by close observation


do I get more information?

Patient organisations supporting kidney cancer patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving kidney cancer patients. If there are no such organisations in your country, please email us for more information: This email address is being protected from spambots. You need JavaScript enabled to view it.


with other patients on this trial

If you want to connect with other patients considering or participating in this trial, you can find them here: List of organisations worldwide.


your experience 

If you would like to share your experience on this trial, send us an e-mail to: This email address is being protected from spambots. You need JavaScript enabled to view it.
Note that your experience would be helpful for other patients and patient organisations.


of the study

No results are available at this time. Future results will be linked here.
Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.
Back to clinical trials overview: How can I find a clinical trial for my cancer?