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Lenvatinib with Everolimus or

Lenvatinib with Pembrolizumab 

Versus Sunitinib Alone as Treatment

of Advanced Renal Cell Carcinoma


 Phase 3 Study Recruiting 1050 patients

 Last updated: November 14, 2018
 STATUS: Recruiting (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 compare the efficacy and safety of new drug combination as a first-line treatment for patients with advanced renal cell carcinoma.

It investigates the multiple kinase inhibitor lenvatinib, either in combination with everolimus (a combination approved for kidney cancer) or combined with a PD-L1 inhibitor pembrolizumab, as compared to sunitinib (a standard first-line therapy for kidney cancer).


patients might want to participate?

This clinical trial offers patients an opportunity to access a new combination 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 open (currently recruiting) – 1050 patients are currently expected to participate.


is the trial available?

The trial is currently recruiting patients in various cancer centres and will be recruiting worldwide. For a complete list of trial locations please see here: clinicaltrials.gov/NCT02811861



What does the study look like?

There will be 3 study arms (groups): all participating patients will be randomly divided (by a computer) into three groups. Please note that patients in all groups will receive an active medication. No patient will receive a placebo.

Patients in group 1 will be assigned lenvatinib (Lenvima™) in combination with everolimus (Afinitor™). Patients in group 2 will be treated with lenvatinib (Lenvima™) in combination with pembrolizumab (Keytruda™). Patients in group 3 will be given sunitinib (Sutent™), which is an approved treatment for RCC.

  • lenvatinib (Lenvima™) is an oral, small-molecule, multiple kinase inhibitor, already approved in combination with everolimus for renal cell carcinoma
  • everolimus (Afinitor™) is an oral mTor-inhibitor, already approved for the treatment of metastatic kidney cancer
  • pembrolizumab (Keytruda™) is a fully human monoclonal antibody targeting PD-1, 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 kidney cancer
1. Lenvatinib is given by mouth once daily in combination with everolimus which is administered orally, once daily as well

2. Lenvatinib is given by mouth once daily in combination with pembrolizumab which is administered intravenously every 3 weeks

3. Sunitinib is taken by mouth once daily on a schedule of 4 weeks on treatment followed by 2 weeks off treatment



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 are participating on this trial and want to share your experiences, please feel free to 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 (with your name omitted) 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?