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RECRUITING
NCT06048484
PHASE2

Combination Therapy in Patients With Localized Pancreatic Ductal Adenocarcinoma

Sponsor: Gulam Manji

View on ClinicalTrials.gov

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

Interventions

RADIATION

Stereotactic body radiotherapy (SBRT)

SBRT 40 gray (Gy) over 5 fractions

DRUG

Zimberelimab

240 mg intravenously (IV)

DRUG

Quemliclustat

100 mg IV

DRUG

Etrumadenant

150 mg orally

DRUG

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