header logo en

 

10 facts web



CHECKMATE 025

 
Study of Nivolumab versus Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma
 
 Last updated: January 29, 2017
 STATUS: Stopped, first results published (per BMS website)

WHO

is the trial for?

Patients with kidney cancer (Renal cell carcinoma, RCC) who currently meet the following criteria:

  • histologic confirmation of RCC with clear-cell component
  • advanced and/or metastatic disease
  • no more than 3 prior systemic treatments for RCC
  • overall health status has to be good (Karnofsky Performance Status (KPS) of at least 70%)

WHAT

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

This phase-III study seeks to clarify whether a new immunotherapy with nivolumab is superior to one of the standard therapies (everolimus) for kidney cancer (RCC).

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 has been stopped early – approx. 822 patients worldwide were participating.
 

Remark: In November 2015 the U.S. Food and Drug Administration approved Opdivo (nivolumab) to treat patients with advanced (metastatic) renal cell carcinoma.

Bristol-Myers Squibb is working to ensure that eligible patients in other countries will be informed of the opportunity to continue or start treatment with Opdivo in an open-label extension as part of the company’s commitment to providing patient access to Opdivo, and characterizing long-term survival.

WHERE

is the trial available?

The trial was available in 158 cancer centers worldwide in 24 countries.
For a complete list of trial locations, please click here:
 

STUDY

DESIGN

What does the study look like?

There were 2 study arms (groups): all participating patients were randomly divided (by a computer) in two groups. Please note that patients in both groups received an active medication. No patient received a placebo.

Patients in one group were assigned nivolumab (OpdivoTM), patients in the other group were treated with everolimus (AfinitorTM), which is an approved treatment for RCC.
  • nivolumab (Opdivo™) is a fully human monoclonal antibody targeting PD-1
  • everolimus (Afinitor™) is an oral, mTor-inhibitor
Study Design Checkmate 025

1) Nivolumab was given intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity or withdrawal of consent.

2) Everolimus was taken by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent.

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: This email address is being protected from spambots. You need JavaScript enabled to view it.

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 

You want 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.

RESULTS

of the study

Results were presented in part at the European Cancer Congress 2015 in Vienna and published in The New England Journal of Medicine. A patient-friendly summary is provided here: Trial results Checkmate 025
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 an IO clinical trial for my cancer?