NOW ENROLLING

Summary

Approximately 580 eligible patients with mCRPC will be randomly assigned to cabozantinib in combination with atezolizumab or to a second NHT (abiraterone or enzalutamide) to evaluate the activity of the combination therapy vs treatment with a second NHT as assessed by PFS by BIRC and OS.

Eligible subjects will be randomly assigned in a 1:1 ratio to one of two treatment arms, an experimental arm or a control arm.

Experimental Arm

Oral cabozantinib qd + atezolizumab infusion q3w

Control Arm

Oral abiraterone qd + oral prednisone bid, or oral enzalutamide qd (designated by the investigator)

• Metastatic CRPC with measurable visceral disease or measurable extrapelvic adenopathy
• Progressive disease as defined by prostate-specific antigen (PSA) progression or soft tissue progression
• Radiographic progression or rising PSA on prior NHT

• Prior treatment with one, and only one, NHT for locally advanced or metastatic CSPC, M0 CRPC, and/or mCRPC
• No prior nonhormonal therapy for mCRPC; prior taxane-based chemotherapy for locally advanced or metastatic CSPC allowed

Multiple Primary Endpoints

• PFS by BIRC
• OS

Secondary Endpoint

• ORR by BIRC

Additional Endpoints

• PSA response rate
• Duration of objective tumor response by investigator
  and BIRC