Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC

Exclusion Criteria

• •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
• •Any prior nonhormonal therapy initiated for the treatment of mCRPC
• •Receipt of abiraterone within 1 week; cyproterone within 10 days; or flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen-receptor inhibitors within 2 weeks before randomization
• •Known brain metastases or cranial epidural disease unless adequately treated and clinically stable at least 4 weeks prior to randomization
• •Symptomatic or impending spinal cord compression or cauda equina syndrome
• •Concomitant anticoagulation with oral anticoagulants (some specific exceptions apply)
• •Administration of a live, attenuated vaccine within 30 days prior to randomization
• •Systematic treatment with, or any condition requiring, either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to randomization
• •Uncontrolled, significant intercurrent or recent illness
• •Major surgery within 4 weeks prior to randomization
• •Corrected QT interval calculated by the Fridericia formula (QTcF) \> 480 ms per ECG within 21 days before randomization
• •Inability or unwillingness to swallow pills or receive IV administration
• •Previously identified allergy or hypersensitivity to components of the study treatment formulations or history of severe infusion-related reactions to monoclonal antibodies
• •Any other active malignancy at time of randomization or diagnosis of another malignancy within 2 years prior to randomization that requires active treatment (some exceptions apply such as locally curable cancers that have apparently been cured).