RecruitingPhase 2NCT06048484

Combination Therapy in Patients With Localized Pancreatic Ductal Adenocarcinoma

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

Sponsor

Gulam Manji

Enrollment

60 participants

Start Date

May 10, 2024

Study Type

INTERVENTIONAL

Conditions

Pancreatic Ductal Adenocarcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Etrumadenant, a drug called Modified FOLFIRINOX, and others for people with pancreatic ductal adenocarcinoma. The study is currently recruiting participants at 5 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic body radiotherapy (SBRT)

SBRT 40 gray (Gy) over 5 fractions

DRUGZimberelimab

240 mg intravenously (IV)

DRUGQuemliclustat

100 mg IV

DRUGEtrumadenant

150 mg orally

DRUGModified 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)