Study Name: SWOG S2200 (PAPMET2)

Recruiting

Renal

SWOG S2200 (PAPMET2): A Phase II Randomized Trial of Cabozantinib (NSC #761968) with or without Atezolizumab (NSC #783608) in Patients with Advanced Papillary Renal Cell Carcinoma

NCT#05411081

clinicaltrials.gov/show/NCT05411081

This phase II trial compares the effect of atezolizumab in combination with usual treatment with cabozantinib to cabozantinib alone in patients with papillary renal cell carcinoma that has spread to other places in the body (metastatic). Papillary renal cell carcinoma (PRCC) is a type of kidney cancer that forms in the lining of the tiny tubes in the kidney that return filtered substances that the body needs back to the blood and remove extra fluid and waste as urine. Most papillary tumors look like long, thin finger-like growths under a microscope. It is also called papillary kidney cancer or PRCC. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help body’s immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply and may also prevent the growth of new blood vessels that tumors need to grow. By these actions it may help slow or stop the spread of cancer cells. Combination therapy with atezolizumab and cabozantinib may shrink the cancer and allow a longer survival time in patients with metastatic renal cell carcinoma.

Male and Female – 18 years and older

• Histo confirmed dx of metastatic papillary RCC
• Must have measurable disease per RECIST 1.1
• NO prior treatment with Cabozantinib in any setting
• No prior treatment or adjuvant therapy w/ PD-1/PD-L1 checkpoint inhibitors for any reason w/i the past 6 months
• No more than 1 prior line of systemic therapy for advanced or metastatic RCC w/the exception of another VEGF inhibitor FDA-approved for advanced RCC (Pazopanib, Bevacizumab, Sorafenib or Axitnib) *If pt develops metastatic dx w/i 6 months of discontinuation of adjuvant therapy, this will constitute one prior systemic therapy for advanced or metastatic RCC. If more than 6 months elapsed, it will not constitute prior systemic therapy.