This phase II trial tests whether cabozantinib with or without atezolizumab works to shrink
tumors in patients with papillary kidney cancer that has spread to other places in the body
(metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab, may
help the body's immune system attack the cancer, and may interfere with the ability of tumor
cells to grow and spread. Giving cabozantinib with atezolizumab may prevent papillary kidney
cancer from growing or spreading compared to cabozantinib alone.
I. To compare progression-free survival in participants with metastatic papillary renal cell
carcinoma (mPRCC) randomized to cabozantinib S-malate (cabozantinib) with atezolizumab versus
I. To compare overall survival in participants with mPRCC randomized to cabozantinib with
atezolizumab versus cabozantinib alone.
II. To compare Response Evaluation Criteria in Solid Tumors (RECIST) objective response rate
(confirmed and unconfirmed, complete and partial response) in participants with mPRCC
randomized to cabozantinib with atezolizumab versus cabozantinib alone.
III. To evaluate the quantitative and qualitive adverse events observed in each treatment
I. To bank biospecimens for future correlative studies.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive cabozantinib S-malate orally (PO) once daily (QD) on days 1-21 of
each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable
toxicity. Patients also undergo computed tomography (CT) and bone scans throughout the trial.
Patients may also undergo collection of blood samples throughout the trial.
ARM II: Patients receive cabozantinib S-malate PO QD on days 1-21 and atezolizumab
intravenously (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in
the absence of disease progression or unacceptable toxicity. Patients also undergo CT and
bone scans throughout the trial. Patients may also undergo collection of blood samples
throughout the trial.
After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for up to 5 years.
Metastatic Papillary Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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