GVAX Pancreas Vaccine (With CY) and CRS-207 With or Without Nivolumab

Phase 2 Completed 93 enrolled Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Aduro Biotech, Inc. · collab American Association for Cancer Research · collab Bristol-Myers Squibb · collab Lustgarten Foundation · collab Stand Up To Cancer · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study is to compare the overall survival (OS) of subjects with previously treated metastatic pancreatic cancer treated with cyclophosphamide (CY)/nivolumab/GVAX pancreas vaccine followed by nivolumab/CRS-207 (Arm A) to subjects treated with CY/GVAX pancreas vaccine followed by CRS-207 (Arm B).

Timeline

Start: 2015-01-02
Primary completion: 2017-07-21
Completion: 2017-07-21

Publications

Hopkins AC, Yarchoan M, Durham JN, Yusko EC, Rytlewski JA, Robins HS, Laheru DA, Le DT, Lutz ER, Jaffee EM. T cell receptor repertoire features associated with survival in immunotherapy-treated pancreatic ductal adenocarcinoma. JCI Insight. 2018 Jul 12;3(13):e122092. doi: 10.1172/jci.insight.122092.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CRS-207	Vaccine	1e+09 unknown	Intravenous
Subject	Nivolumab	Monoclonal antibody	3 mg/kg	Intravenous
Background	CY — 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2	Unknown	200 mg/m2	Intravenous
Background	GVAX	Vaccine	5e+08 cells	Other

GVAX Pancreas Vaccine (With CY) and CRS-207 With or Without Nivolumab

Summary

Timeline

Publications

Drugs

Indications