Please note that this summary only contains information from the full scientific abstract: View ESMO Scientific Abstract

Effect of avelumab + axitinib compared with sunitinib alone in people with advanced kidney cancer who did not have kidney surgery

Date of summary: September 2019

Study number: NCT02684006


Study start date: March 2016


Estimated study end date: May 2024


The full title of this abstract is: Primary renal tumour shrinkage in patients (pts) who did not undergo upfront cytoreductive nephrectomy (uCN): subgroup analysis from the phase 3 JAVELIN Renal 101 trial of first-line avelumab + axitinib (A + Ax) vs sunitinib (S) for advanced renal cell carcinoma (aRCC)

Sunitinib is approved to treat the condition under
study that is discussed in this summary. Axitinib and
avelumab are not approved to treat the condition
under study that is discussed in this summary. The
combination of avelumab plus axitinib is not approved
in Europe to treat the condition under study that is
discussed in this summary.


Researchers must look at the results of many types
of studies to understand whether a study drug
works, how it works, and whether it is safe to
prescribe to patients.

This summary reports the results of only one study.
The results of this study might be different from the
results of other studies that the researchers look at.


This summary reports the interim results from the
study – results may not be the same when the
study is complete.


More information can be found in the scientific
abstract of this study, which you can access here:
View ESMO Scientific Abstract

What did this study look at?

  • Advanced renal cell carcinoma (aRCC for short) is a type of kidney cancer.
    • Advanced means that the cancer has spread within the kidneys or to other parts of the body.
  • Avelumab is a study treatment for people with aRCC. It is given to people as an injection.
    • Avelumab binds to a protein called PD-L1 on cancer cells. PD-L1 tells immune (defense) cells not to attack cancer cells.
    • When avelumab binds to PD-L1, it may prevent PD-L1 from working correctly. This releases the ‘brakes’ on the body’s immune system, which can allow immune cells to attack and destroy the cancer cells.
  • Axitinib and sunitinib are approved treatments for people with aRCC. People take them as tablets. Axitinib is approved for use after sunitinib or other treatments have failed.
    • These treatments may prevent cancers from forming new blood vessels. This can slow the cancer’s growth or cause cancer cells to die.
  • This ongoing study is looking at how well avelumab and axitinib work together, compared with sunitinib by itself, in people with aRCC.
  • This summary looks at results from the group of people who had a primary kidney tumor and did not have surgery to remove the affected kidney.
    • A primary kidney tumor is the cancer that first started growing in the kidney before it spread to other places.

Who took part in this study?

What were the results of the study?

  • Researchers looked at the results in people with aRCC who had a primary kidney tumor and did not previously have
    surgery to remove their kidney.
  • Around 8 in 10 people whose primary kidney tumors shrank also had tumors in other parts of their bodies that shrank substantially
    • Researchers saw this for people treated with avelumab + axitinib or with sunitinib alone

More results from this study can be found here:
View ESMO Scientific Abstract

What was the main conclusion reported by the researchers?

  • A higher proportion of people who received avelumab + axitinib in this study had primary kidney tumors that shrank substantially compared with people receiving sunitinib alone.
    • This is the first time researchers have reported that combining these types of drugs can shrink primary kidney tumors in people with aRCC who did not have their kidney removed.
    • Avelumab + axitinib may be a potential treatment option for people newly diagnosed with aRCC.

Who sponsored this study?

Pfizer Inc.
235 East 42nd Street NY, NY 10017
Phone (United States): +1 212-733-2323

Pfizer would like to thank all of the
people who took part in this study.

Click to show further information on the study and clinical trials in general