Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC
Summary
This is a Phase 3, multi-center, randomized, open-label, controlled study designed to evaluate the safety and efficacy of cabozantinib given in combination with atezolizumab versus a second novel hormonal therapy (NHT) in men with metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with one, and only one, NHT for their prostate cancer disease.
Timeline
- Start
- 2020-10-19
- Primary completion
- 2024-04-19
- Completion
- 2026-10-16
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
paper cabozantinib plus atezolizumab significantly improved progression-free survival versus ARPI switch reads as mixed primary results PMID 40523369 ↗
registry analysis (superiority test); Experimental Arm: Cabozantinib and Atezolizumab vs Control Arm: Second NHT; p = 0.0007 reads as mixed primary results NCT04446117 ↗
paper overall survival was not significantly different between the cabozantinib plus atezolizumab and ARPI switch groups reads as mixed primary results PMID 40523369 ↗
registry analysis (superiority test); Experimental Arm: Cabozantinib and Atezolizumab vs Control Arm: Second NHT; p = 0.2956 reads as mixed primary results NCT04446117 ↗
release “global phase 3 CONTACT-02 pivotal trial met one of two primary endpoints, demonstrating a statistically significant improvement in progression-free survival (PFS) at the primary analysis.” reads as mixed primary results exelixis.com ↗
release “global CONTACT-02 pivotal Phase III trial of Cabometyx® plus atezolizumab in metastatic castration-resistant prostate cancer met one of two primary endpoints” reads as mixed primary results ipsen.com ↗
release “CONTACT-02 met one of its primary endpoints, demonstrating a statistically significant improvement in progression-free survival” reads as mixed primary results exelixis.com ↗
release “While a trend toward OS improvement was observed, the data were immature and did not meet the threshold for statistical significance.” reads as mixed primary results exelixis.com ↗
release “positive results from the primary PFS analysis in the global phase 3 CONTACT-02 pivotal trial” reads as met primary endpoint exelixis.com ↗
release “CONTACT-02 met one of its two primary endpoints, demonstrating a statistically significant benefit in PFS in the predefined PFS ITT population” reads as mixed primary results exelixis.com ↗
release “the final analysis of OS showed a numerical but not statistically significant improvement favoring cabozantinib in combination with atezolizumab” reads as mixed primary results exelixis.com ↗
Publications
- Agarwal N, Azad AA, Carles J, Matsubara N, Oudard S, Saad F, Merseburger AS, Soares A, McGregor BA, Zurawski B, Tsiatas M, North S, Bondarenko I, Alfie M, Bournakis E, Antonuzzo L, Evilevitch L, Simmons A, Wang F, Ferraldeschi R, Nandoskar P, Pal SK. Cabozantinib plus atezolizumab in metastatic prostate cancer (CONTACT-02): final analyses from a phase 3, open-label, randomised trial. Lancet Oncol. 2025 Jul;26(7):860-876. doi: 10.1016/S1470-2045(25)00209-8. Epub 2025 Jun 13.
- Agarwal N, Azad A, Carles J, Chowdhury S, McGregor B, Merseburger AS, Oudard S, Saad F, Soares A, Benzaghou F, Kerloeguen Y, Kimura A, Mohamed N, Panneerselvam A, Wang F, Pal S. 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Abiraterone acetate | Small molecule | 1000 mg | Oral |
| Subject | Atezolizumab | Monoclonal antibody | 1200 mg | Intravenous |
| Subject | Cabozantinib | Small molecule | 40 mg | Oral |
| Comparator | Enzalutamide | Other / unclassified | 160 mg | Oral |
| Comparator | Prednisone | Other / unclassified | 5 mg | Oral |