Actively Recruiting
Zimberelimab and Quemliclustat in Combination With Chemotherapy for the Treatment of Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma
Led by Jonsson Comprehensive Cancer Center · Updated on 2026-01-15
56
Participants Needed
1
Research Sites
208 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
This phase I/II study tests how well zimberelimab and quemliclustat work in combination with chemotherapy (mFOLFIRINOX) in treating patients pancreatic adenocarcinoma that may or may not be able to be removed by surgery (borderline resectable) or that has spread to nearby tissue or lymph nodes (locally advanced). Immunotherapy with monoclonal antibodies, such as zimberelimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Quemliclustat acts as a blocker for adenosine. Adenosine is a chemical produced in the body that can lead to a decrease in the immune system's response towards cancer. Quemliclustat has the potential to decrease the amount of adenosine, allowing the immune system to recognize and act against the cancer. Chemotherapy drugs, such as oxaliplatin, irinotecan, leucovorin, and fluorouracil, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy in combination with zimberelimab and quemliclustat may kill more cancer cells than chemotherapy alone.
CONDITIONS
Official 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 aged 18 years or older able to provide informed consent
- Previously untreated pancreatic adenocarcinoma confirmed by biopsy or cytology
- Diagnosis of borderline resectable or locally advanced pancreatic cancer as defined by specific CT criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate blood counts: ANC ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin ≥ 9 g/dL
- Kidney function with serum creatinine ≤ 1.5 times upper limit or creatinine clearance ≥ 40 mL/min
- Liver enzymes AST and ALT ≤ 2.5 times upper limit of normal
- Women with no childbearing potential or at least 1 year postmenopausal or confirmed menopause
- Women of childbearing potential must use effective nonhormonal contraception during and for 6 months after treatment
- Male participants must use effective contraception during and for 6 months after treatment
- Discontinuation of immunosuppressive doses of corticosteroids at least 14 days before treatment
- Recovery from any major surgery at least 4 weeks prior to treatment and regional anesthesia at least 72 hours prior
You will not qualify if you...
- Recurrent or metastatic pancreatic adenocarcinoma
- Peripheral neuropathy greater than grade 2
- Uncontrolled HIV infection (CD4 <300) or untreated hepatitis B or active hepatitis C infection
- Medical conditions posing risk with investigational treatment including interstitial lung disease, active infections needing IV treatment, significant cardiovascular disease
- Previous solid organ transplant
- Active or recent second primary cancer within 5 years except for non-melanoma skin cancer
- Serious cardiac conditions including NYHA Class III/IV heart failure or recent myocardial infarction
- Uncontrolled bleeding disorders or recent major bleeding
- Known pregnancy or nursing; positive pregnancy test
- Conditions interfering with study participation or safety as judged by investigator
- Recent trauma or major surgery within 28 days prior to first treatment
- Psychiatric or substance abuse disorders affecting cooperation
- Active or recent autoimmune diseases within 3 years except certain stable conditions
- History of systemic steroids or immunosuppressants except for specified exceptions
- Asthma requiring intermittent bronchodilator use is allowed
AI-Screening
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Trial Site Locations
Total: 1 location
1
Yonemoto,Lisa
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
L
Lisa Yonemoto
CONTACT
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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