Actively Recruiting
Zimberelimab and Quemliclustat Combined With Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma
Led by Jonsson Comprehensive Cancer Center · Updated on 2026-05-22
56
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
J
Jonsson Comprehensive Cancer Center
Lead Sponsor
A
Arcus Biosciences, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of zimberelimab and quemliclustat with chemotherapy (mFOLFIRINOX) for treating patients with borderline resectable or locally advanced pancreatic adenocarcinoma. This phase I/II study aims to assess the safety, tolerability, and treatment effects including resection rates and progression-free survival. Immunotherapy with monoclonal antibodies like zimberelimab may help the immune system fight cancer, while quemliclustat blocks adenosine to potentially enhance immune response against the tumor. Chemotherapy drugs work by stopping cancer cell growth and spread, and this combination may improve outcomes compared to chemotherapy alone. Participants receive intravenous zimberelimab, quemliclustat, oxaliplatin, leucovorin calcium, and irinotecan as part of the treatment. Those with borderline resectable pancreatic cancer will have tissue samples collected, while patients with locally advanced disease will undergo core biopsies. Blood samples and CT scans are taken throughout the trial to monitor the disease and treatment effects. The study includes primary objectives such as evaluating adverse events, resection rates, progression-free survival, and pancreatic fistula development, along with secondary and exploratory goals related to tumor response and biological markers. During the study, participants are closely monitored with imaging, blood tests, and biopsies to evaluate treatment response and safety. The study measures outcomes like CA 19-9 tumor marker changes, objective response rate, pathologic complete response, and overall survival up to two years. Safety is assessed up to 90 days after the last treatment dose. The trial duration and follow-up periods are designed to provide detailed information on how this combination therapy affects pancreatic cancer progression and patient outcomes.
CONDITIONS
Brief Title
Zimberelimab and Quemliclustat in Combination With Chemotherapy for the Treatment of Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years of age or older who can provide informed consent
- Diagnosis of untreated pancreatic adenocarcinoma with borderline resectable or locally advanced disease as defined by specific CT criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Absolute neutrophil count (ANC) of at least 1.5 x 10^9/L
- Platelet count of at least 100 x 10^9/L
- Hemoglobin level of at least 9 g/dL
- Serum creatinine less than or equal to 1.5 times upper limit of normal or creatinine clearance at least 40 mL/min
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 times upper limit of normal
- Women with no childbearing potential or postmenopausal for at least 1 year
- Women of childbearing potential using effective nonhormonal contraception during and up to 6 months after last dose
- Male participants using effective contraception during and up to 6 months after last dose
- Discontinuation of immunosuppressive doses of corticosteroids at least 14 days before treatment
- Recovery from prior surgery at least 4 weeks before treatment (regional anesthesia at least 72 hours before)
You will not qualify if you...
- Recurrent or metastatic pancreatic adenocarcinoma
- Peripheral neuropathy greater than grade 2
- Uncontrolled HIV infection (CD4 less than 300); controlled HIV or hepatitis C with undetectable viral load allowed
- Untreated active hepatitis B or C infection
- Significant medical conditions such as interstitial lung disease, active infections requiring treatment, significant cardiovascular disease, or unresolved adverse events from prior drugs
- History of solid-organ transplantation
- Active second primary malignancy or history of malignancy within 5 years (except certain skin cancers)
- Serious heart disease including New York Heart Association Class III/IV cardiac disease or recent myocardial infarction
- Uncontrolled blood clotting disorders or recent major bleeding
- Known pregnancy, nursing, or positive pregnancy test
- Conditions interfering with study participation or safety as judged by investigator
- Recent trauma or major surgery within 28 days prior to treatment
- Psychiatric or substance abuse disorders interfering with study cooperation
- Active or recent autoimmune diseases except certain stable or treated conditions
- History of systemic steroids or immunosuppressive therapy for syndromes except for specific exceptions such as resolved asthma or vitiligo
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive zimberelimab, quemliclustat, and chemotherapy drugs intravenously. Blood samples and CT scans are collected throughout the treatment period. Participants with borderline resectable pancreatic cancer provide tissue samples, while those with locally advanced pancreatic cancer undergo core biopsy.
Multiple visits for drug administration and monitoring
Duration - Up to 2 years
Participants are monitored for safety, surgical outcomes, and disease progression after treatment ends.
Periodic visits for outcome assessments
Trial Site Locations
Total: 1 location
1
Yonemoto,Lisa
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
L
Lisa Yonemoto
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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