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Combination Therapy in Patients With Localized Pancreatic Ductal Adenocarcinoma

NCT06048484 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-02-27

No results posted yet for this study

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.

Conditions

Interventions

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)

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

Sponsors & Collaborators

  • Arcus Biosciences, Inc.

    collaborator INDUSTRY

  • Gulam Manji

    lead OTHER

Principal Investigators

  • Gulam Manji, MD, PhD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-10
Primary Completion
2027-04-30
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06048484 on ClinicalTrials.gov