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CHECKMATE 800

 
An Investigational Immuno-Therapy Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma
 
 Phase 2, 100 patients
 Last updated: March 07, 2017
 STATUS: Recruiting (accepting new patients) (per ClinicalTrials.gov/NCT03029780)

WHO

is the trial for?

Patients with kidney cancer (Renal cell carcinoma, RCC) who currently meet the following criteria:
  • advanced Renal Cell Carcinoma
  • must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
  • no prior therapy with checkpoint inhibitor
  • no known or suspected autoimmune disease

WHAT

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

The purpose of this phase 2 study is to evaluate safety and efficacy of different administration regimens of a new drug combination in participants with advanced renal cell carcinoma.

This particular study investigates different dosing regimens of the combination of two immune-checkpoint inhibitors ipilimumab and nivolumab in advanced renal cell carcinoma.

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) – 100 patients are currently expected to participate.

WHERE

is the trial available?

The trial will be available in various cancer centres in the USA, Australia and Chile.
A complete list of trial locations will be published here: Trial locations Checkmate 800

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. Please note that patients in both groups will receive an active medication. No patient will receive a placebo.

Patients in group 1 will be assigned nivolumab and ipilimumab in co-administration (medications given together). Patients in group 2 will be treated with nivolumab and ipilimumab in sequential administration (medications given one after the other).

  • nivolumab (Opdivo™) is a fully human monoclonal antibody targeting PD-1 that is already approved for renal cell carcinoma
  • ipilimumab (Yervoy™) is a fully human monoclonal antibody targeting CTLA-4 that is not yet approved for renal cell carcinoma
 

1.) The combination of nivolumab and ipilimumab is given intravenously in co-administration.

2.) Nivolumab and ipilimumab are given intravenously in sequential administration (medications given one after the other).

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 

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.

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 kidney cancer?