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Combination Therapy in Patients With Localized Pancreatic Ductal Adenocarcinoma
Sponsor: Gulam Manji
Summary
The purpose of this study is to combine standard radiation therapy with drugs that encourages the body's immune system against cancer cells and simultaneously adding drugs which also target the pathway that the tumor uses to evade the immune system (CD73 and A2a/b). The study hopes that these drugs will work in concert with radiation therapy to kill cancer cells. The specific goal of this study is to ensure that treatment with zimberelimab and stereotactic body radiation therapy (SBRT) alone or in combination with quemliclustat (a drug which blocks CD73), with or without etrumadenant (a drug which blocks the A2a/b) given before surgery is safe and if it can further increase the immune response against the tumor.
Official title: A Phase 2, Open-Label, Multicenter, Randomized Study Evaluating Neoadjuvant Therapy Targeting the Adenosine Immunosuppressive Pathway in Combination With Immune Checkpoint Blockade and Radiation Therapy in Patients With Advanced PANCreatic Ductal Adenocarcinoma Who Are Candidates for Surgical Resection
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-05-10
Completion Date
2027-04
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
Stereotactic body radiotherapy (SBRT)
SBRT 40 gray (Gy) over 5 fractions
Zimberelimab
240 mg intravenously (IV)
Quemliclustat
100 mg IV
Etrumadenant
150 mg orally
Modified FOLFIRINOX
* Oxaliplatin 85 mg per square meter IV * Irinotecan 150 mg per square meter IV * Leucovorin 400 mg per square meter IV * Fluorouracil 2400 mg per square meter IV * Pegfilgrastim injector kit (6mg subcutaneous)
Locations (5)
Northwell Health R.J. Zuckerberg Cancer Center
Lake Success, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States