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PROSPER RCC
 

Perioperative nivolumab in M0 RCC
 
 
 Phase 3; 766 patients 
 Last updated: July 05, 2017
 STATUS: Recruiting (accepting new patients) (perClinicalTrials.gov/NCT03055013)

WHO

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)
  • localized disease with high risk of recurrence
  • mandatory pre-surgical biopsy
  • all histologies permitted

WHAT

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

This phase 3 study seeks to evaluate the efficacy and safety of a new immuno-oncological treatment in participants with RCC who are at high risk of disease recurrence following nephrectomy.

It investigates the immune-checkpoint inhibitor nivolumab given before and after surgery.

WHY

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.

WHEN

will the trial be open?

The study is open (currently recruiting) – 766 patients worldwide are currently expected to participate.

WHERE

is the trial available?

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

STUDY

DESIGN

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).

Patients in group 1 will be treated with nivolumab (Opdivo™) before and after surgery. Patients in group 2 will have surgery and will be closely observed.
  • nivolumab (Opdivo™) is a fully human monoclonal antibody targeting PD-1
Prosper Trial

1) Before surgery, the patient will receive 2 doses of nivolumab intravenously, two weeks apart. After surgery (resection of the tumour), the patient will receive nivolumab every two weeks for 3 months and afterwards every 4 weeks for 6 months (9 months altogether).

2) Patients will have the surgery (resection of the tumour) followed by close observation.

HOW

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: Cette adresse e-mail est protégée contre les robots spammeurs. Vous devez activer le JavaScript pour la visualiser.

CONNECT

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.

SHARE

your experience 

If you would like to share your experience on this trial, send us an e-mail to: Cette adresse e-mail est protégée contre les robots spammeurs. Vous devez activer le JavaScript pour la visualiser.
Note that your experience would be helpful for other patients and patient organisations.

RESULTS

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?