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Phase Ib/II Trial of Lenvatinib (E7080)

Plus Pembrolizumab in Subjects With

Selected Solid Tumours

 
 
 Last updated: July 06, 2017
 STATUS: Recruiting (accepting new patients) (per ClinicalTrials.gov/NCT02501096)

WHO

is the trial for?

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

  • confirmed metastatic disease that:
  • has progressed after treatment with an approved therapy, or
  • for which there are no standard effective therapies available
For phase II of the trial:
  • up to two prior treatments for kidney cancer
  • overall health status has to be good (ECOG 0 to 1)

WHAT

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

This study aims to evaluate the safety and tolerability of a combination of two drugs for patients with selected solid tumours, including kidney cancer, as well as the potential effect it may have on the body and the tumour.

Phase Ib will determine and confirm the maximum tolerated dose for lenvatinib (LenvimaTM), an approved therapy for kidney cancer in the U.S., in combination with pembrolizumab (KeytrudaTM). The phase II trial will evaluate the safety and efficacy of the combination at the maximum tolerated dose from phase Ib.

WHY

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.

WHEN

will the trial be open?

The study is open (recruiting) – 250 patients within the USA are currently expected to participate.

WHERE

is the trial available?

The trial is currently recruiting patients in various cancer centres in the USA: Trial locations

Contact details:
Eisai Medical Services
1-888-422-4743 (within the USA)

STUDY

DESIGN

What does the study look like?

The trial will be done in two parts:

Part A – Phase Ib trial:
The Phase I portion of the study will determine the maximum tolerated dose of lenvatinib (an approved therapy for kidney cancer in the U.S.) when given in combination with pembrolizumab. Lenvatinib (LenvimaTM) will be administered with water orally once a day (with or without food) using a dose escalation scheme. This means that the dose will slowly get higher until the disease progresses or unacceptable side effects occur. Pembrolizumab (KeytrudaTM) will be given as a dose of 200 mg intravenously in a 21-day treatment cycle.

  • lenvatinib (LenvimaTM) is an oral, multiple kinase inhibitor already approved for the treatment of kidney cancer when used in combination with everolimus (AfinitorTM) (in the USA)
  • pembrolizumab (Keytruda™) is a fully human monoclonal antibody targeting PD-1
Part B – Phase II:
When the best dose is found, lenvatinib will be administered at the maximum tolerated dose (MTD) as determined in Part A, in combination with pembrolizumab.

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 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.

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 an IO clinical trial for my cancer?