Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC
- Trial number:
- NCT04446117
- Trial phase:
- 3
- Study type:
- Immunotherapy, Targeted therapy
- Overall status:
- Recruiting
Study start date
Scientific title
Summary
Men with histologically or cytologically confirmed adenocarcinoma of the prostatePrior treatment with one, and only one, NHT (eg, abiraterone, apalutamide, darolutamide, or enzalutamide) for castration-sensitive locally advanced (T3 or T4) or mCSPC, M0 CRPC, or mCRPC Surgical or medical castration, with serum testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening Measurable (extrapelvic soft tissue) metastatic disease per Investigator assessment defined by at least one of the following: measurable visceral disease (eg, adrenal, kidney, liver, lung, pancreas, spleen) per RECIST 1.1; OR measurable extrapelvic adenopathy (ie, adenopathy above the aortic bifurcation) Progressive disease at study entry as defined by specific criteria for prostate specific antigen (PSA) progression OR soft tissue disease progression in the opinion of the Investigator (Note: subjects with bone disease progression alone are not eligible) Age ≥ 18 years old or meeting country definition of adult, whichever is older, on the day of consent ECOG performance status of 0 or 1 Recovery to baseline or ≤ Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy in the opinion of the Investigator Adequate organ and marrow function based upon specific laboratory assessments obtained within 21 days prior to randomization Understanding and ability to comply with protocol requirements