Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas

NCT02451982 ↗

Phase 2 Active not recruiting 76 enrolled Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Bristol-Myers Squibb · collab National Cancer Institute (NCI) · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This platform trial will evaluate various immunotherapy combinations given in the neo-adjuvant and adjuvant setting in patients with surgically resectable pancreatic ductal adenocarcinoma.

Timeline

Start: 2016-03-28
Primary completion: 2026-09-30
Completion: 2026-09-30

Outcome

Met primary endpoint

paper Treatment with GVAX+nivolumab+urelumab meets the primary endpoint by significantly increasing intratumoral CD8+ CD137+ cells (p = 0.003) compared to GVAX+Nivolumab. PMID 37339979 ↗

Publications

Heumann T, Judkins C, Li K, Lim SJ, Hoare J, Parkinson R, Cao H, Zhang T, Gai J, Celiker B, Zhu Q, McPhaul T, Durham J, Purtell K, Klein R, Laheru D, De Jesus-Acosta A, Le DT, Narang A, Anders R, Burkhart R, Burns W, Soares K, Wolfgang C, Thompson E, Jaffee E, Wang H, He J, Zheng L. A platform trial of neoadjuvant and adjuvant antitumor vaccination alone or in combination with PD-1 antagonist and CD137 agonist antibodies in patients with resectable pancreatic adenocarcinoma. Nat Commun. 2023 Jun 20;14(1):3650. doi: 10.1038/s41467-023-39196-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ADAKITUG	Monoclonal antibody	2400 mg	Intravenous
Subject	Cyclophosphamide	Other / unclassified	200 mg/m2	Intravenous
Subject	GVAX pancreatic cancer	Vaccine	5e+08 cells	Other
Subject	Nivolumab	Monoclonal antibody	480 mg	Intravenous
Subject	Urelumab	Monoclonal antibody	8 mg	Intravenous