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Combination Therapy for Localized Pancreatic Cancer

This study is looking at new ways to treat localized pancreatic ductal adenocarcinoma (a type of pancreatic cancer). It combines standard radiation therapy (SBRT) with several drugs: zimberelimab, quemliclustat, and etrumadenant. These drugs aim to boost your body's immune system to fight cancer cells and block pathways tumors use to hide from the immune system. Researchers want to see if these combinations are safe and if they can increase the immune response against the tumor before surgery. This study is for adults aged 18 and older with confirmed pancreatic adenocarcinoma. The main goal is to measure changes in specific immune cells (CD8+ T-cells) in the tumor after treatment.

Study design
This interventional study plans to enroll 60 participants. It has two stages, with Stage 2 involving randomization into different treatment groups.
What's involved
Participants will undergo 5 days of SBRT and receive various combinations of zimberelimab, quemliclustat, and etrumadenant for 7 weeks before surgery.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes in immune cells around the time of surgery (Perioperative).

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NCT06048484

Combination Therapy in Patients With Localized Pancreatic Ductal Adenocarcinoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
Gulam Manji
~60 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:Stereotactic body radiotherapy (SBRT)ZimberelimabQuemliclustatEtrumadenantModified FOLFIRINOX

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in the number of intratumoral CD8+ T-cells
Measured over Perioperative

Conditions

Pancreatic Ductal Adenocarcinoma

Explore related trials

Pancreatic Ductal Adenocarcinoma

NCT06048484

Where you'd take part

This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Columbia University Irving Medical Center

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsinstudy coordinator listed

    Recruiting

  • Northwell Health R.J. Zuckerberg Cancer Center

    Lake Success, New Yorkstudy coordinator listed

    Recruiting

  • UNC Hospitals, The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolinastudy coordinator listed

    Recruiting

  • University of Pennsylvania, Abramson Cancer Center

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Gulam Manji, MD, PhD · PRINCIPAL_INVESTIGATOR · Columbia University

Who to contact

Research Nurse Navigator
[email protected]
212-342-5162
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Eligibility criteria

Inclusion

Histological or pathological confirmation of pancreatic adenocarcinoma Cytologic or histologic proof of pancreatic ductal adenocarcinoma (PDAC) needs to be verified by the treating institution pathologist. A pathological report from non-treating institutions is sufficient to consent and to initiate investigational therapy if tissue sample is unavailable for evaluation at time of consent or enrollment. However, in such a case, PDAC diagnosis should be confirmed by the treating institution pathologist at a later time.
Completed 8 cycles of neoadjuvant modified FOLFIRINOX. Omission of oxaliplatin due to adverse events may be allowed in cycles 5-8 with consultation with the principal investigator.
Patients with surgically resectable PDAC who are considered appropriate to undergo the applicable operation.
Eligible to undergo SBRT.
Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
No prior surgical, systemic, or radiotherapy for PDAC except for mFOLFIRINOX.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Age ≥ 18 years.
Adequate hematological and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of investigational treatment:

Exclusion

Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies, including but not limited to anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies.
Patients who are receiving any other investigational agents concurrently.
Concomitant treatment with other anti-neoplastic agents (hormonal therapy acceptable).
Uncontrolled pleural effusion, pericardial effusion, or ascites.
Uncontrolled hypercalcemia (ionized calcium \> 1.5 mmol/L, calcium \> 12 mg/dL, or corrected serum calcium \> ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy.
Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease (Crohn's disease or ulcerative colitis), antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis (some exceptions permissible as outlined per protocol).
History of idiopathic pulmonary fibrosis, interstitial lung disease, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
Positive HIV test at screening or at any time prior to screening.
Active hepatitis B virus (HBV) infection (chronic or acute), defined as having a positive hepatitis B surface antigen (HBsAg) test at screening.
Note: Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody test at screening, are eligible for the study.
Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test followed by a positive HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test.
Known clinically significant liver disease, including alcoholic hepatitis, cirrhosis, fatty liver disease, and inherited liver disease.
Known active tuberculosis.
Inability to swallow medication or malabsorption condition that would alter the absorption of orally administered medications.
Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents and breastfeeding should be discontinued.
History of allergy or hypersensitivity to oxaliplatin, irinotecan, leucovorin, fluorouracil, pegfilgrastim, or any excipients.
History of Gilbert's disease or known genotype UGT1A1 \*28/\*28.
Inflammatory disease of the colon or rectum, or severe uncontrolled diarrhea.
Active or history of celiac disease.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

What this trial measures

  • Change in the number of intratumoral CD8+ T-cellsPerioperative

    The primary endpoint is change in the number of intratumoral CD8+ T-cells at time of surgery between treatment arm(s) compared to the SBRT + zimberelimab arm (Control Arm B). To obtain CD8+ T-cell count, simple immunohistochemistry (IHC) will be used to quantitate CD8+ T-cells. A designated gastrointestinal (GI) pathologist will review each hematoxylin and eosin (H\&E) stained serial section and IHC slide to oversee the process. Representative areas within the slide will be used for cell counts.