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Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy in Participants With Renal Cell Carcinoma
 Phase 3; 840 patients worldwide expected to participate
 Last updated: April 09, 2018
 STATUS: Active, not Recruiting (not accepting new patients) (per ClinicalTrials.gov/NCT02811861)


is the trial for?

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


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

The purpose of this phase 3 study is to evaluate the efficacy and safety of a new immuno-therapy in combination with a standard drug for kidney cancer.

It investigates the combination of the PD-L1 inhibitor pembrolizumab (MK-3475) plus axitinib compared to sunitinib (an already approved therapy for kidney cancer).


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.


will the trial be open?

The study is ongoing but not recruiting new patients – 840 patients worldwide are currently expected to participate.


is the trial available?

The trial will be available in 26 cancer centres worldwide.
For a complete list of trial locations, please click here:
 Trial locations KEYNOTE 029



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 receives a placebo.

Patients in one group will be assigned axitinib (Inlyta™) in combination with pembrolizumab (Keytruda™, MK 3475). Patients in the other group will be treated with sunitinib (Sutent™), which is an approved treatment for RCC.

  • axitinib (Inlyta™) is an oral, small-molecule, tyrosine kinase inhibitor, already approved for the treatment of metastatic renal cell carcinoma
  • pembrolizumab (Keytruda™) is a fully human monoclonal antibody targeting PD-1 that is not yet approved for renal cell carcinoma
  • sunitinib (Sutent™) is an oral, small-molecule, multi-targeted receptor tyrosine kinase inhibitor, already approved for the treatment of metastatic RCC
Keynote 426
1.) Pembolizumab will be given intravenously every three weeks; axitinib is taken by mouth twice a day (every 12 hours).

2.) Sunitinib is taken by mouth once daily for 4 weeks then 2 weeks off.


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.


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.


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.


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?