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KEYNOTE 564

 
A Study of Pembrolizumab as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Following Nephrectomy
 Phase 3; 950 patients
 Last updated: November 29, 2017
 STATUS: recruiting (accepting new patients) (per https://clinicaltrials.gov/NCT03142334)

WHO

is the trial for?

Patients with kidney cancer (Renal cell carcinoma, RCC) who currently meet the following criteria:
  • clear cell component with or without sarcomatoid features
  • kidney cancer classified as being at intermediate-high risk or high risk of recurrence after radical or partial nephrectomy
  • no prior systemic therapy for advanced kidney cancer (except nephrectomy or metastasectomy)
  • overall health status has to be good (ECOG score of 0 or 1)

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.

This study investigates the PD-L1 inhibitor pembrolizumab (Keytruda™) as compared to intravenous placebo to determine the effect on disease recurrence.

WHY

patients might want to participate?

This clinical trial offers patients an opportunity to access a new therapy that may be effective in the adjuvant setting for 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?

The study is open (currently recruiting) – 950 patients worldwide are currently expected to participate.

WHERE

is the trial available?

The trial will be available in various cancer centres worldwide.
For a complete list of trial locations, please click here:
 Trial locations KEYNOTE 564
 

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 an intravenous placebo (saline solution).

Patients in group 1 (50%) will be assigned pembrolizumab (Keytruda™). Patients in the other group (50%) will be assigned an intravenous placebo. The trial is blinded, which means that participants will not know whether they are being treated with pembrolizumab or placebo.

Keynote 564
 

1.) Pembolizumab will be given intravenously every three weeks for up to 17 cycles (each cycle=21 days)

2.) Placebo (saline solution) will be given intravenously every 3 weeks for 17 cycles (each cycle=21 days)

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?