Phase Ib and Phase II Studies of MK-3475 in Combination + for Renal Cell Carcinoma:

Phase 1/2 Completed 61 enrolled Arkadiusz Z. Dudek, MD Big Ten Cancer Research Consortium · collab Merck Sharp & Dohme LLC · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is an open label, multi-institutional, single arm study of dose escalation phase Ib cohort, followed by a phase II cohort of anti-PD-1 antibody MK-3475 in combination with bevacizumab. No randomization or blinding is involved.

Timeline

Start: 2015-03
Primary completion: 2019-12-05
Completion: 2019-12-05

Outcome

Met primary endpoint

paper The primary end point was met, with the ORR reaching 60.9% (95% CI, 45.4% to 74.9%), PMID 32097091 ↗

Publications

Dudek AZ, Liu LC, Gupta S, Logan TF, Singer EA, Joshi M, Zakharia YN, Lang JM, Schwarz JK, Al-Janadi A, Alva AS. Phase Ib/II Clinical Trial of Pembrolizumab With Bevacizumab for Metastatic Renal Cell Carcinoma: BTCRC-GU14-003. J Clin Oncol. 2020 Apr 10;38(11):1138-1145. doi: 10.1200/JCO.19.02394. Epub 2020 Feb 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bevacizumab	Monoclonal antibody	10 mg	Intravenous
Subject	Bevacizumab	Monoclonal antibody	15 mg	Intravenous
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous