AtezoCab: A Phase II Study of Cabozantinib in Combination With Atezolizumab in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) With Non-Measurable Disease
University of Utah
Summary
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.
Description
PRIMARY OBJECTIVE: I. To evaluate the disease control rate in metastatic castration-resistant prostate cancer (mCRPC) patients with non-measurable disease as assessed by Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 SECONDARY OBJECTIVES: I. To evaluate the efficacy of the combination as measured by prostate-specific antigen (PSA) progression-free survival (PFS). II. To evaluate the efficacy of the combination as measured by PSA 50% response rate. III. To evaluate the efficacy of the combination as measured by radiogra…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Disease progression on or after at least one prior novel hormonal therapy (NHT) (defined as second-generation antiandrogen therapies that include but are…
Interventions
- BiologicalAtezolizumab
Given IV
- DrugCabozantinib S-malate
Given PO
Location
- Huntsman Cancer Institute/University of UtahSalt Lake City, Utah