A Phase III, randomized, open-label study (CONTACT-02) of cabozantinib plus atezolizumab versus second novel hormone therapy in patients with metastatic castration-resistant prostate cancer.

Cabozantinib inhibits multiple receptor tyrosine kinases, including the TAM kinase family, and may enhance response to immune checkpoint inhibitors. One cohort of the ongoing Phase Ib COSMIC-021 study (NCT03170960) evaluating cabozantinib plus the PD-L1 inhibitor atezolizumab in men with metastatic castration-resistant prostate cancer (mCRPC) that has progressed in soft tissue on/after enzalutamide and/or abiraterone treatment for metastatic disease has shown promising efficacy. Here, we describe the rationale and design of a Phase III trial of cabozantinib plus atezolizumab versus a second novel hormone therapy (NHT) in patients who have previously received an NHT for mCRPC, metastatic castration-sensitive PC or nonmetastatic CRPC and have measurable visceral disease and/or extrapelvic adenopathy - a population with a significant unmet need for treatment options. Trial Registration Clinical Trial Registration: NCT04446117 (ClinicalTrials.gov) Registered on 24 June 2020.

Future oncology (London, England). 2022 Jan 17 [Epub ahead of print]

Neeraj Agarwal, Arun Azad, Joan Carles, Simon Chowdhury, Bradley McGregor, Axel S Merseburger, Stéphane Oudard, Fred Saad, Andrey Soares, Fawzi Benzaghou, Yannick Kerloeguen, Akiko Kimura, Nehal Mohamed, Ashok Panneerselvam, Fong Wang, Sumanta Pal

Huntsman Cancer Institute (NCI-CCC), University of Utah, Salt Lake City, UT84112, USA., Peter MacCallum Cancer Centre & Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC 3000, Australia., Vall d'Hebron Institut d'Oncología, Vall d'Hebron University Hospital, 08035 Barcelona, Spain., Guy's, King's & St. Thomas' Hospitals, & Sarah Cannon Research Institute, London, SE1, UK., Lank Center of Genitourinary Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA 02215, USA., Department of Urology, University Hospital Schleswig-Holstein, 23562, Lübeck, Germany., Department of Medical Oncology, European Georges Pompidou Hospital, University of Paris, 75015 Paris, France., Department of Urology, Centre Hospitalier de l'Université de Montréal/CRCHUM, Montreal, QC, Canada., Department of Oncology, Hospital Israelita Albert Einstein, São Paulo, 05652-900, Brazil., Ipsen Bioscience, Inc., Cambridge, MA 02142, USA., F. Hoffmann-La Roche Ltd, 4070 Basel, Switzerland., Takeda Pharmaceutical Company Limited, Osaka, 540-8645, Japan., Exelixis, Inc., Alameda, CA 94502, USA., Department of Medical Oncology & Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, CA 91010, USA.