This phase II trial tests whether cabozantinib and atezolizumab work to shrink tumors in patients with castrate-resistant prostate cancer that had 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 and atezolizumab may kill more tumor cells in patients with metastatic castrate-resistant prostate cancer.
Male subject aged >= 18 years
Histologically or cytologically confirmed prostatic adenocarcinoma without small cell histology
Metastatic disease progression after continuous androgen deprivation therapy for hormone sensitive state
Patient must have non-measurable disease outside the pelvis (above aortic bifurcation) per RECIST 1.1 criteria. Non-measurable disease can be bone lesions and/or extraskeletal disease
Prior chemotherapy in the metastatic castration refractory prostate cancer setting is not allowed (taxane-based in metastatic castration-sensitive disease is allowed)
Prior treatment with cabozantinib, CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-a, anti-PD1 and anti-PD-L1 therapeutic antibodies
Prior treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment
Single group
Atezolizumab
Biological/VaccineGiven IV
Cabozantinib S-malate
DrugGiven PO
Disease control rate
Measured per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 with a 95% confidence interval.
Prostate-specific antigen (PSA) progression-free survival (PFS)
Kaplan-Meier methods will be used to analyze PFS and will be presented with 95% confidence intervals. PSA progression is defined by PCWG3 criteria.
PSA 50% response rate
Will be monitored per treatment schedule to assess the proportion of patients with a 50% reduction in PSA levels (PSA50) compared to the baseline value at the time of study enrollment.
Radiographic Progression-free survival (PFS)
Kaplan-Meier methods will be used to analyze PFS and will be presented with 95% confidence intervals. Measured with RESIST 1.1. The disease progression date defined as the time between the start date of treatment and the date of first recurrence or death from any cause.
Overall survival
Will be evaluated for survival using Kaplan-Meier estimation.
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University of Utah
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Huntsman Cancer Institute
Collaborator
