Adding The Drug Atezolizumab to a Usual Treatment for Advanced Papillary Renal Cell Cancer
What is the purpose of this clinical trial?
Papillary renal cell cancer is a rare type of kidney cancer that forms in small tubes of the kidney. This study will test treatment for papillary renal cell cancer that has spread to other places in
the body. Researchers want to find out if a usual treatment for this cancer can be improved by combining it with the study drug atezolizumab.
This trial is set up to find out:
- If adding the study drug to usual treatment helps people live longer with this type of kidney cancer before the cancer gets worse
- How people with this type of kidney cancer respond to usual treatment plus the study drug compared to usual treatment without the study drug
- What side effects people have with the different treatments
Why is this trial important?
Advanced kidney cancer can be difficult to treat, and doctors want to improve treatment for it. The study drug atezolizumab is an immunotherapy drug that may help the immune system fight cancer. It is approved by the Food and Drug Administration (FDA) to treat other advanced cancers, including some types of kidney cancer. Adding it to usual treatment may work better than the usual treatment alone for advanced papillary renal cell cancer.
Who can be in this trial?
This trial is for adults, age 18 and older, with papillary renal cell cancer that has spread to other places in the body.
Talk with your doctor to learn more about who can join this study.
This trial may be for people who:
This trial is not for people who:
- Have heart problems or poor liver function
- Have an autoimmune disease
- Have an active HIV, hepatitis B, or hepatitis C infection
- Have certain gastrointestinal (GI) disorders
- Are pregnant
What treatments will I get?
A computer will randomly assign you to one of 2 study groups.
Your doctor will not have control over which group you will be assigned to. This helps make sure the study results are fair and reliable.
Group 1: Usual treatment
Group 2: Usual treatment and study drug
How long will I be in the trial?
You will be in the study for 5 years. Your study doctor will closely watch you for side effects and watch how your cancer responds to the treatment. You may continue treatment until it stops working or if you have side effects that are too severe. You may choose to stop treatment at any time for any reason.
If you stop getting treatment, you will have follow-up visits with the study team until 5 years after you started the study.
Are there costs? Will I get paid?
The drugs cabozantinib and atezolizumab are provided free to you. You will not be paid for joining. You will not be paid for joining the study. Check with your health care provider and insurance provider to find out what costs will and won't be covered in this study.
Where can I find more information about this trial?
- Talk with your health care provider
- Call the National Cancer Institute at 1-800-4-CANCER
- Go to www.ClinicalTrials.gov and search using the national clinical trial number: 05411081