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Study Of Avelumab With Axitinib

Versus Sunitinib In Advanced Renal

Cell Cancer (JAVELIN Renal 101)

 
 
 Last updated: July 05, 2017
 STATUS: Recruiting (accepting new patients) (per ClinicalTrials.gov/NCT02684006)

WHO

is the trial for?

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

  • histologically or cytologically confirmed advanced renal cell carcinoma with clear cell component
  • at least one measureable lesion that has not been previously irradiated
  • no prior systemic treatment
  • tumour tissue [formalin-fixed paraffin-embedded (FFPE)] has to be
    available
  • overall health status has to be good (ECOG 0 or 1) with
  • adequate bone marrow function, renal and liver functions

WHAT

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

This phase-III study aims to evaluate the anti-tumor activity and safety of a new combination of immunotherapy + axitinib given as first-line treatment, in patients with advanced renal cell carcinoma.

The study has been designed to investigate whether the antibody targeting programmed death ligand 1 (anti PD-L1) avelumab given in combination with axitinib will be more effective than sunitinib (alone) as first-line treatment for patients with advanced, or metastatic renal cell carcinoma (RCC).

Both axitinib (InlytaTM) and sunitinib (SutentTM) are tyrosine kinase inhibitors, already approved for the treatment of advanced kidney cancer.

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) – 583 patients are currently expected to participate.

WHERE

is the trial available?

This Phase 3 trial will be available in 214 cancer centres world-wide.
For contact details, please click here: Trial locations Javelin renal 101
 

STUDY

DESIGN

What does the study look like?

The study has been designed to compare the results from patients in two 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 receive a placebo.

Patients in one group will be assigned avelumab in combination with axitinib (InlytaTM). Patients in the other group will be treated with sunitinib (SutentTM), which is an approved standard of care first-line treatment for RCC.
  • avelumab is an antibody targeting programmed death ligand 1 (anti PD-L1), given intravenously every two weeks
  • axitinib (Inlyta™) is an oral, small-molecule, tyrosine kinase inhibitor, already approved for the treatment of metastatic renal cell carcinoma, taken orally twice per day
  • sunitinib (Sutent™) is an oral, small-molecule, multi-targeted receptor tyrosine kinase inhibitor, already approved for the treatment of metastatic RCC, taken once per day
 
1)The combination of avelumab and axitinib will be given as follows until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends:
  • avelumab is administered intravenously every two weeks
  • axitinib is taken by mouth twice a day, ongoing
2) Sunitinib is taken by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity (side effects), withdrawal of consent, or the study ends.

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?