CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma

Summary

Tthe primary objective of this study is to compare blinded Independent Radiology Committee (IRC)-adjudicated progression free survival (PFS) of patients treated with CB-839 + cabozantinib (CB-Cabo) versus placebo + cabozantinib (Pbo-Cabo) for advanced or metastatic clear-cell RCC (ccRCC).

Timeline

Start

2018-04-24

Primary completion

2020-08-31

Completion

2021-07-16

Outcome

Missed primary endpoint

paper Median progression-free survival was 9.2 months for Tela + Cabo vs 9.3 months for Pbo + Cabo (HR, 0.94; 95% CI, 0.74-1.21; P = .65). PMID 36048457 ↗

paper CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, telaglenastat did not improve the efficacy of cabozantinib in metastatic RCC. PMID 36048457 ↗

Publications

• Tannir NM, Agarwal N, Porta C, Lawrence NJ, Motzer R, McGregor B, Lee RJ, Jain RK, Davis N, Appleman LJ, Goodman O Jr, Stadler WM, Gandhi S, Geynisman DM, Iacovelli R, Mellado B, Sepulveda Sanchez JM, Figlin R, Powles T, Akella L, Orford K, Escudier B. Efficacy and Safety of Telaglenastat Plus Cabozantinib vs Placebo Plus Cabozantinib in Patients With Advanced Renal Cell Carcinoma: The CANTATA Randomized Clinical Trial. JAMA Oncol. 2022 Oct 1;8(10):1411-1418. doi: 10.1001/jamaoncol.2022.3511.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CB-839	Unknown	800 mg	Oral
Background	Cabozantinib	Small molecule	60 mg	Oral

Indications