CONTACT-02

Prostate cancer

A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination with Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects with Metastatic Castration-Resistant Prostate Cancer

• Men with histologically or cytologically confirmed adenocarcinoma of the prostate
• 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

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