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NOW ENROLLING

Phase 3 Study of Cabozantinib With Atezolizumab vs Second Novel Hormonal Therapy in mCRPC

The combination of cabozantinib and atezolizumab is not
approved for the use under investigation in this trial.
Safety and efficacy have not been established.

Study Overview

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 40 mg qd + atezolizumab 1200 mg infusion q3w

Control Arm

Oral abiraterone 1000 mg qd + oral prednisone 5 mg bid, or oral enzalutamide 160 mg qd (designated by the investigator)

Key Eligibility
Criteria

  • 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

Key Endpoints

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

PARTICIPATING SITES

CONTACT•02 will be conducted in: North America, South America, Europe, and Asia Pacific. Call 1-888-393-5494 (toll-free) or 1-303-389-1847 for specific location and site information and to confirm whether sites near you are still enrolling new patients.

Currently open or planned clinical site cities:

      • Duarte
      • Fullerton
      • San Diego
      • Santa Monica
      • Aurora
      • Denver
      • Miami
      • Kansas City
      • Baltimore
      • Omaha
      • East Brunswick
      • Las Vegas
      • Cleveland
      • Oklahoma City
      • Philadelphia
      • Nashville
      • Houston
      • Temple
      • Salt Lake City
      • Blacksburg
      • Ciudad Autónoma de Buenos Aires
      • Buenos Aires
      • Mar Del Plata
      • La Rioja
      • San Salvador De Jujuy
      • Viedma
      • San Juan
      • Launceston
      • Melbourne
      • Ballarat
      • Frankston
      • Box Hill
      • ADELAIDE
      • Garran
      • Wollongong
      • Linz
      • Bonheiden
      • Bruxelles
      • Gent
      • Roeselare
      • Barretos
      • São José do Rio Preto
      • Ribeirão Preto
      • Vila Olímpia
      • Santa Cruz do Sul
      • Porto Alegre
      • Fortaleza
      • Mercês
      • Blumenau
      • Edmonton
      • Kelowna
      • Moncton
      • London
      • Oakville
      • Hamilton
      • Montréal
      • Temuco
      • Santiago
      • Recoleta
      • Viña del Mar
      • Olomouc
      • Praha
      • Praha 4
      • Praha 2
      • Praha 8
      • Brno
      • Strasbourg
      • Dijon cedex
      • Saint-Grégoire
      • Quimper Cedex
      • NIMES cedex 9
      • Strasbourg cedex
      • Toulouse
      • Toulouse Cedex 9
      • Paris
      • Clermont-Ferrand
      • Tbilisi
      • Gütersloh
      • Tübingen
      • Piraeus
      • Cholargos
      • Thessaloniki
      • Heraklion
      • Filadelfeos
      • Larissa
      • Gyula
      • Budapest
      • Petah Tikva
      • Tel Aviv
      • Bat Galim
      • Jerusalem
      • Tzefat
      • Ramat Gan
      • Firenze
      • Roma
      • Perugia
      • Terni
      • Akita
      • Hirosaki-Shi
      • Kashiwa
      • Sapporo
      • Kobe
      • Miki
      • Sagamihara
      • Yokohama-Shi
      • Nagano-shi
      • Osaka
      • Osaka-Sayama-Shi
      • Hidaka-Shi
      • Chiba
      • Sakura-shi
      • Koto
      • Shinjuku-ku
      • Wakayama
      • Ube
      • Bydgoszcz
      • Poznań
      • Braga
      • Lisbon
      • Porto
      • Moscow
      • Saint Petersburg
      • Singapore
      • Busan
      • Daejeon
      • Gwangju
      • Goyang-si
      • Seongnam-si
      • Busan
      • Daegu
      • Hwasun-gun
      • Seoul
      • Busan-si
      • Barcelona
      • Manresa
      • Córdoba
      • Lugo
      • Alcorcón
      • Valdefuentes
      • Madrid
      • Sevilla
      • Taichung City
      • Taoyuan
      • Tainan
      • Dnipro
      • Kyiv
      • Lutsk

Trial sites may stop enrolling patients at any time. Please check back if you do not see a trial site located near you.

Learn more about this trial at clinicaltrials.gov and search for NCT04446117, or contact Exelixis Medical Information at 1-888-393-5494 (toll-free) or 1-303-389-1847 or druginfo@exelixis.com.