Study of Pembrolizumab With or Without Defactinib Following Chemotherapy as a Neoadjuvant and Adjuvant Treatment for Resectable Pancreatic Ductal Adenocarcinoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

June 4, 2019

Primary Completion Date

January 15, 2025

Study Completion Date

January 15, 2026

Conditions
Resectable Pancreatic Ductal Adenocarcinoma (PDAC)Pancreatic Ductal Adenocarcinoma
Interventions
DRUG

Pembrolizumab

Following standard of care neoadjuvant chemotherapy, subjects will receive two doses of pembrolizumab (200mg) IV 3 weeks apart prior to surgery. After surgery, subjects will receive adjuvant standard of care chemotherapy. Following adjuvant chemotherapy, subjects will receive 8 doses of pembrolizumab (200mg) IV 3 weeks apart.

DRUG

Defactinib

Following 2 cycles of standard of care neoadjuvant chemotherapy, subjects will receive 400 mg defactinib twice a day up until 2 days preceding their surgery (approximately 6 weeks) during the immunotherapy cycles with pembrolizumab. After surgery, subjects will receive adjuvant standard of care chemotherapy. Following adjuvant chemotherapy, subjects will receive 400mg defactinib twice a day for 24 weeks.

Trial Locations (3)

21231

Sidney Kimmel Comprehensive Cancer Center, Baltimore

78229

The University of Texas Health Science Center San Antonio, San Antonio

90048

Samuel Oschin Cancer Center at Cedars-Sinai, Los Angeles

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

Verastem, Inc.

INDUSTRY

lead

Lei Zheng

OTHER