A Study of Atezolizumab in Combination With Cabozantinib Compared to Cabozantinib Alone in Participants With Advanced Renal Cell Carcinoma After Immune Checkpoint Inhibitor Treatment
Summary
This is a Phase III, multicenter, randomized, open-label study designed to evaluate the efficacy and safety of atezolizumab given in combination with cabozantinib versus cabozantinib alone in participants with inoperable, locally advanced, or metastatic renal cell carcinoma (RCC) who experienced radiographic tumor progression during or after Immune Checkpoint Inhibitor (ICI) treatment in the metastatic setting.
Timeline
- Start
- 2020-07-28
- Primary completion
- 2023-01-03
- Completion
- 2025-03-24
Outcome
Missed primary endpoint
Stopped: “As the study did not meet it's primary endpoint a decision was made to terminate the study.”
registry analysis (other test); Cabozantinib (Control) vs Atezolizumab + Cabozantinib; p = 0.7844; Hazard Ratio (HR) 1.03 (95% CI 0.83 to 1.28); Log Rank NCT04338269 ↗
registry analysis (other test); Cabozantinib (Control) vs Atezolizumab + Cabozantinib; p = 0.6902; Hazard Ratio (HR) 0.94 (95% CI 0.70 to 1.27); Log Rank NCT04338269 ↗
release “the phase 3 CONTACT-03 study did not meet its primary endpoint of progression-free survival (PFS).” exelixis.com ↗
Publications
- Pal SK, Albiges L, Tomczak P, Suarez C, Voss MH, de Velasco G, Chahoud J, Mochalova A, Procopio G, Mahammedi H, Zengerling F, Kim C, Osawa T, Angel M, Gupta S, Khan O, Bergthold G, Liu B, Kalaitzidou M, Huseni M, Scheffold C, Powles T, Choueiri TK. Atezolizumab plus cabozantinib versus cabozantinib monotherapy for patients with renal cell carcinoma after progression with previous immune checkpoint inhibitor treatment (CONTACT-03): a multicentre, randomised, open-label, phase 3 trial. Lancet. 2023 Jul 15;402(10397):185-195. doi: 10.1016/S0140-6736(23)00922-4. Epub 2023 Jun 5.
- Yang Y, Psutka SP, Parikh AB, Li M, Collier K, Miah A, Mori SV, Hinkley M, Tykodi SS, Hall E, Thompson JA, Yin M. Combining immune checkpoint inhibition plus tyrosine kinase inhibition as first and subsequent treatments for metastatic renal cell carcinoma. Cancer Med. 2022 Aug;11(16):3106-3114. doi: 10.1002/cam4.4679. Epub 2022 Mar 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | 1200 mg | Intravenous |
| Subject | Cabozantinib | Small molecule | 60 mg | Oral |