drugset

drugset / Trial / NCT02301039

SARC028: A Phase II Study of the Anti-PD1 Antibody Pembrolizumab (MK-3475) in Patients With Advanced Sarcomas

NCT02301039 ↗

Phase 2 Completed 144 enrolled Sarcoma Alliance for Research through Collaboration Merck Sharp & Dohme LLC · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the efficacy of pembrolizumab in patients with advanced sarcomas.

Timeline

Start: 2015-03
Primary completion: 2020-07-01
Completion: 2020-07-01

Outcome

Missed primary endpoint

paper The primary endpoint of overall response was not met for either cohort. PMID 28988646 ↗

Publications

Tawbi HA, Burgess M, Bolejack V, Van Tine BA, Schuetze SM, Hu J, D'Angelo S, Attia S, Riedel RF, Priebat DA, Movva S, Davis LE, Okuno SH, Reed DR, Crowley J, Butterfield LH, Salazar R, Rodriguez-Canales J, Lazar AJ, Wistuba II, Baker LH, Maki RG, Reinke D, Patel S. Pembrolizumab in advanced soft-tissue sarcoma and bone sarcoma (SARC028): a multicentre, two-cohort, single-arm, open-label, phase 2 trial. Lancet Oncol. 2017 Nov;18(11):1493-1501. doi: 10.1016/S1470-2045(17)30624-1. Epub 2017 Oct 4.

Drugs

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

Indications