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

Future Oncol. 2022 Mar;18(10):1185-1198. doi: 10.2217/fon-2021-1096. Epub 2022 Jan 17.

Abstract

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.

Keywords: TAM kinase inhibitor; atezolizumab; cabozantinib; immune checkpoint inhibitor; metastatic castration-resistant prostate cancer; novel hormone therapy; phase III; receptor tyrosine kinase inhibitor; trial in progress.

Publication types

  • Clinical Trial Protocol
  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adenocarcinoma / drug therapy*
  • Adenocarcinoma / pathology
  • Androstenes / therapeutic use
  • Anilides / therapeutic use*
  • Antibodies, Monoclonal, Humanized / therapeutic use*
  • Antineoplastic Agents, Hormonal / therapeutic use*
  • Benzamides / therapeutic use
  • Humans
  • Immune Checkpoint Inhibitors / therapeutic use*
  • Male
  • Neoplasm Metastasis
  • Nitriles / therapeutic use
  • Phenylthiohydantoin / therapeutic use
  • Prostatic Neoplasms, Castration-Resistant / drug therapy*
  • Prostatic Neoplasms, Castration-Resistant / pathology
  • Pyridines / therapeutic use*
  • Receptor Protein-Tyrosine Kinases / antagonists & inhibitors

Substances

  • Androstenes
  • Anilides
  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Agents, Hormonal
  • Benzamides
  • Immune Checkpoint Inhibitors
  • Nitriles
  • Pyridines
  • cabozantinib
  • Phenylthiohydantoin
  • atezolizumab
  • enzalutamide
  • Receptor Protein-Tyrosine Kinases
  • abiraterone

Associated data

  • ClinicalTrials.gov/NCT04446117

Grant support