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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Lei Zheng
Study ID
NCT03727880
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    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.
  • Defactinib — DRUG
    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.

Study Details

This study will test the effectiveness (anti-tumor activity), safety, and ability to increase the body's immune system to fight pancreatic cancer by combining standard chemotherapy before and after surgery, with study drug PD-1 antibody, pembrolizumab, with and without study drug, focal adhesion kinase inhibitor (FAK), defactinib, in people with "high risk" resectable (surgically removable) pancreatic cancer. The purpose of this study is to evaluate if reprograming the tumor microenvironment by targeting FAK following chemotherapy can potentiate anti-programmed death-1 (PD-1) antibody.

Key Dates

Start date
Jun 4, 2019
Status verified
Jan 2026
Primary completion
Jan 15, 2025
Completion
Jan 15, 2025

Study Design

Enrollment
28 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A - Pembrolizumab and Defactinib
  • Experimental: Arm B - Pembrolizumab

Primary Outcome Measure

Pathologic Complete Response (pCR) Rate [ Time Frame: 4 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Samuel Oschin Cancer Center at Cedars-SinaiLos AngelesCalifornia90048-
Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21231-
The University of Texas Health Science Center San AntonioSan AntonioTexas78229-

Related coverage on Hipa.ai

Find similar trials in Los Angeles, CA

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Samuel Oschin Cancer Center at Cedars-Sinai· Los Angeles, CASidney Kimmel Comprehensive Cancer Center· Baltimore, MDThe University of Texas Health Science Center San Antonio· San Antonio, TX

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