PROBE S1931

Location: Edward Cancer Center - Naperville
Edward Cancer Center - Plainfield
Nancy Knowles Cancer Center - Elmhurst

Purpose:

This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based drug combination versus a standard of care immunotherapy-based drug combination alone in treating patients with kidney cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, pembrolizumab, and avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Surgery to remove the kidney, called a nephrectomy, is also considered standard of care; however, doctors who treat kidney cancer do not agree on its benefits. It is not yet known if the addition of surgery to an immunotherapy-based drug combination works better than an immunotherapy-based drug combination alone in treating patients with kidney cancer.

Sponsor: SWOG

https://clinicaltrials.gov/ct2/show/NCT04510597

Eligibility:

• Participants must have a histologically proven diagnosis of clear cell or non-clear cell renal cell carcinoma. Participants with collecting duct carcinoma histology are not eligible.
• Participants with multifocal or bilateral tumors are eligible
• Participants must have scans documenting metastatic disease 
• Participants must be a surgical candidate 
• Participants must not have received any systemic therapy for metastatic renal cell carcinoma beyond the line intended as part of protocol therapy or the one regimen received off protocol prior to randomization 
• Treatment naive participants must not have received any immunotherapy within a year of registration
• Previously treated participants must not have received any other immunotherapy within a year of the start of off protocol specified pre-randomization treatment
• Participants must not have a solitary kidney and not have a transplanted kidney
• No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, any in situ or T1 cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for at least two years

Time Commitment: Up to 7 years