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CHECKMATE 914

 
A Study Comparing the Combination of Nivolumab and Ipilimumab Versus Placebo in Participants With Localised Renal Cell Carcinoma
 
 Phase 3, 800 patients
 Last updated: November 29, 2017
 STATUS: recruiting (accepting new patients) (per ClinicalTrials.gov/NCT03138512)

WHO

is the trial for?

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

WHAT

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

The purpose of this phase 3 study is to determine whether the combination of nivolumab and ipilimumab is safe and effective for delaying or preventing recurrence of kidney cancer. It is designed for patients who have recently undergone surgery for kidney cancer (partial or entire removal of the kidney). These patients must have a high risk of disease recurrence (high risk of developing metastasis following nephrectomy).

This particular study investigates the combination of the immune-checkpoint inhibitors nivolumab and ipilimumab in localised kidney cancer.

WHY

patients might want to participate?

The current standard of care for localised kidney cancer following nephrectomy is close observation. This clinical trial offers patients an opportunity to access a new therapy in the adjuvant setting that may be effective for delaying and preventing recurrence of kidney cancer.

This trial will support further 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?

This study is open (currently recruiting) – 800 patients are currently expected to participate.

WHERE

is the trial available?

The trial will be available in various cancer centres in the USA, Germany, Russia, and the U.K.. For a complete list of trial locations, please click here: Trial locations Checkmate 914

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 one group will receive intravenous placebo (saline solution). The trial will be blinded which means that neither the patient nor the medical team will know who receives the active medication and who receives the placebo (saline solution).

Patients in group 1 (50% of patients) will be treated with nivolumab and ipilimumab. Patients in group 2 (50% of patients) will be assigned a placebo.

  • nivolumab (Opdivo™) is a fully human monoclonal antibody targeting PD-1
  • ipilimumab (Yervoy™) is a fully human monoclonal antibody targeting CTLA-4
Checkmate 914 

1) The combination of nivolumab and ipilimumab is given intravenously (into the vein). Infusions are given every 3 weeks for a 24-week period (4 doses of the combination of nivolumab + ipilimumab, then 4 doses of nivolumab alone)

2) A placebo medication (saline solution) is given intravenously (into the vein) every 3 weeks for a 24-week period

HOW

do I get more information?

Patient organisations supporting kidney cancer patients in your country may offer additional information about this 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?