Clinical Trial Summary (S1931)
Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy with or without Surgery to Remove the Kidney in Metastatic Kidney Cancer
What is the purpose of this clinical trial?
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This trial is for people who have metastatic kidney cancer (cancer that’s spread to other places in the body). The study asks if adding surgery to the usual treatment with a combination of drugs can help patients live longer. |
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The study will compare 2 different treatment approaches:
| Usual Treatment
standard systemic therapy (SST) |
Study Treatment
standard systemic therapy (SST) |
The drug combination you’ll get in the study will include at least 1 immunotherapy drug. Immunotherapy helps your immune system fight cancer.
This trial is set up to find out:
- If adding surgery to a standard combination of drugs can help people with metastatic kidney cancer live longer
- If adding surgery to a standard combination of drugs can help shrink the cancer
- What surgery complications and drug side effects people might have
Why is this trial important?
Most people with metastatic kidney cancer are treated with a combination of drugs that includes newer immunotherapy drugs. This study may help doctors learn whether adding surgery to these drug combinations helps patients live longer than treating them with the drugs alone.
Who can be in this trial?
This trial is for adults age 18 or older who have renal cell carcinoma, the most common type of kidney cancer.
This trial may be for people who:
- Have metastatic cancer
- Have not received any immunotherapy drugs yet — or already received the treatment described in Step 1 below for 6 to 18 weeks
This trial is not for people who:
- Already had surgery to remove the kidney
- Have had a kidney transplant
Talk with your doctor to learn more about who can join this study.
What treatments will I get?
Step 1
Everyone in the study will get standard treatment with a combination of drugs. If you’ve already received treatment for 6 to 18 weeks (depending on which drug combination you’re getting), you’ll start the study at Step 2.
You and your doctor will decide which drug combination you’ll get.
After you’ve received the drugs for about 12 weeks, you’ll get an MRI or CT scan to check the cancer:
- If the cancer has gotten worse, your part in the study will be over. Talk with your doctor about other possible treatment options.
- If the cancer is stable or has shrunk, you’ll move on to Step 2.
Step 2
Group 1: standard drug combination
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Group 2: standard drug combination + kidney removal surgery
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Your doctor will not have control over which group you’re assigned to. This helps make sure the
study results are fair and reliable.
All the drugs you’ll receive during the study are approved by the FDA.
How long will I be in the trial?
If you move on to Step 2, you’ll be in the study for 7 years total. You’ll keep receiving treatment until the cancer gets worse or the side effects get so bad that you decide to stop.
At first, you’ll have visits with your study doctor every 3 months so they can see how you’re doing and if the cancer has gotten worse. You’ll have these visits less often over time.
Are there costs? Will I get paid?
To learn what costs will and won’t be covered, talk to your health care provider and insurance provider.
You will not be paid for joining the 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 the national clinical trial number: NCT04510597
- For a list of trial locations, visit swog.org/NCI-S1931
Key Information
Information your doctor or trial navigator may need to help you.
Protocol Number
S1931
NCT Number
NCT04510597
Full Trial Title
Phase III Trial of Immunotherapy- Based Combination Therapy with or without Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma (PROBE Trial)
Trial Sponsors
SWOG Cancer Research Network
Publication Date