Study of GVAX (With CY) and Pembrolizumab in MMR-p Advanced Colorectal Cancer

Phase 2 Completed 17 enrolled Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Merck Sharp & Dohme LLC · collab

NaSingle-groupOpen-labelTreatment

Summary

This study will be looking at the objective response rate (ORR) as measured by RECIST in in patients with mismatch repair-proficient (MMR-p), advanced colorectal cancer that treated with CY/GVAX in combination with Pembrolizumab.

Timeline

Start: 2017-05-26
Primary completion: 2018-03-20
Completion: 2018-03-20

Outcome

Missed primary endpoint

paper There were no objective responses, and the disease control rate was 18% by RECIST 1.1. PMID 31876399 ↗

paper GVAX/Cy plus pembrolizumab failed to meet its primary objective in MMRp CRC. PMID 31876399 ↗

Publications

Results Yarchoan M, Huang CY, Zhu Q, Ferguson AK, Durham JN, Anders RA, Thompson ED, Rozich NS, Thomas DL 2nd, Nauroth JM, Rodriguez C, Osipov A, De Jesus-Acosta A, Le DT, Murphy AG, Laheru D, Donehower RC, Jaffee EM, Zheng L, Azad NS. A phase 2 study of GVAX colon vaccine with cyclophosphamide and pembrolizumab in patients with mismatch repair proficient advanced colorectal cancer. Cancer Med. 2020 Feb;9(4):1485-1494. doi: 10.1002/cam4.2763. Epub 2019 Dec 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Colon GVAX	Unknown	5e+07 cells	Other
Subject	Colon GVAX	Unknown	5e+08 cells	Other
Subject	Cyclophosphamide	Other / unclassified	200 mg/m2	Intravenous
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous