Actively Recruiting
Combination Therapy in Patients With Localized Pancreatic Ductal Adenocarcinoma
Led by Gulam Manji · Updated on 2026-02-27
60
Participants Needed
5
Research Sites
150 weeks
Total Duration
On this page
Sponsors
G
Gulam Manji
Lead Sponsor
A
Arcus Biosciences, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Combination Therapy in Patients With Localized Pancreatic Ductal Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological or pathological confirmation of pancreatic ductal adenocarcinoma
- Completed 8 cycles of neoadjuvant modified FOLFIRINOX (oxaliplatin omission allowed in cycles 5-8 with approval)
- Surgically resectable pancreatic ductal adenocarcinoma appropriate for surgery
- Eligible to undergo stereotactic body radiation therapy (SBRT)
- Measurable disease as per RECIST 1.1
- No prior surgery, systemic, or radiotherapy for pancreatic ductal adenocarcinoma except modified FOLFIRINOX
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Age 18 years or older
- Adequate hematological and organ function based on labs within 14 days before treatment start
You will not qualify if you...
- Prior treatment with T-cell co-stimulating or immune checkpoint therapies (e.g., anti-CTLA-4, anti-PD-1, anti-PD-L1)
- Concurrent use of other investigational agents
- Treatment with other anti-cancer agents except hormonal therapy
- Uncontrolled pleural, pericardial effusion, or ascites
- Uncontrolled or symptomatic hypercalcemia needing bisphosphonates
- Active or history of autoimmune diseases or immune deficiency (some exceptions per protocol)
- History of idiopathic pulmonary fibrosis, interstitial lung disease, pneumonitis, or active pneumonitis on chest CT
- Positive HIV test
- Active hepatitis B or C infection
- Significant liver disease including alcoholic hepatitis, cirrhosis, fatty liver, or inherited liver diseases
- Active tuberculosis
- Inability to swallow medication or malabsorption affecting oral drug absorption
- Pregnancy or breastfeeding
- Allergy or hypersensitivity to oxaliplatin, irinotecan, leucovorin, fluorouracil, pegfilgrastim, or excipients
- History of Gilbert's disease or UGT1A1 *28/*28 genotype
- Inflammatory bowel disease or severe uncontrolled diarrhea
- Active or history of celiac disease
- Psychiatric or substance abuse disorders interfering with trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Northwell Health R.J. Zuckerberg Cancer Center
Lake Success, New York, United States, 11042
Actively Recruiting
2
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
3
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
4
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
5
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
R
Research Nurse Navigator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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