Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas

Phase 0 Completed 11 enrolled Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Eli Lilly and Company · collab Merck Sharp & Dohme LLC · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate whether combining cyclophosphamide (CY), pembrolizumab, GVAX and IMC-CS4 is effective and safe in patients with borderline resectable pancreatic cancer.

Timeline

Start: 2018-09-27
Primary completion: 2022-03-09
Completion: 2023-08-29

Outcome

Met primary endpoint

paper Comparison of paired biopsies showed five of eight evaluable patients met the immunologic endpoint with >80% increase in CD8+ T cells. PMID 41878443 ↗

paper CI has a manageable safety profile and leads to increased intratumoral cytotoxic effector T cells. PMID 41878443 ↗

Publications

Urman A, Ding Y, Durham J, Wang H, Qi H, Narang A, Burkhart R, He J, Le D, Laheru D, Thompson E, Jaffee E, Purtell K, Waisome-Stephens C, Liu M, Zheng L, De Jesus-Acosta A. Safety and immunologic impact of neoadjuvant/adjuvant GVAX, cyclophosphamide, pembrolizumab, and anti-CSF1R agent IMC-CS4 in pancreatic adenocarcinoma. Front Immunol. 2026 Mar 9;17:1715761. doi: 10.3389/fimmu.2026.1715761. eCollection 2026.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cyclophosphamide	Other / unclassified	200 mg/m2	Intravenous
Subject	GVAX Pancreas Vaccine (GVAX)	Vaccine	5e+08 cells	Other
Subject	IMC-CS4	Unknown	75 mg	Intravenous
Subject	IMC-CS4	Unknown	100 mg	Intravenous
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous