Zimberelimab and Quemliclustat with Chemotherapy for Pancreatic Cancer
This study is testing a combination of treatments for pancreatic cancer that is either borderline resectable (meaning it might be able to be removed by surgery) or locally advanced (meaning it has spread to nearby tissues or lymph nodes). The treatments include zimberelimab and quemliclustat, given with standard chemotherapy (mFOLFIRINOX). Zimberelimab is an immunotherapy that helps your immune system fight cancer. Quemliclustat blocks a chemical called adenosine, which can weaken the immune system's response to cancer. Researchers want to see how safe this combination is, how well it helps patients, and if it leads to more successful surgeries for borderline resectable cancer. The study aims to enroll 56 participants aged 18 and older who have not yet received treatment for their pancreatic cancer.
- Study design
- This interventional study plans to enroll 56 participants. It is testing the safety and effectiveness of a drug combination for pancreatic cancer.
- What's involved
- You would undergo blood and tissue sample collection, CT scans, and core biopsies. You would also receive fluorouracil and irinotecan intravenously (through a vein).
- Compensation
- Not stated in the trial record.
- Follow-up
- Your health would be monitored for adverse events for up to 90 days after your last dose of study treatment. Progression-free survival and resection rates will be measured for up to 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05688215
Zimberelimab and Quemliclustat in Combination With Chemotherapy for the Treatment of Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma
Recruiting
PHASE1Ages 18+InterventionalTreatmentJonsson Comprehensive Cancer CenterInvestigator-initiated
~56 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Biospecimen CollectionComputed TomographyCore BiopsyFluorouracilIrinotecanLeucovorin
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events (BPRC Cohort)
Measured over From baseline measurement to 90 days after the last dose of study treatment.
+3 more outcomes measured
Conditions
NCT05688215
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Yonemoto,Lisa
Los Angeles, Californiastudy 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
- Zev A Wainberg · PRINCIPAL_INVESTIGATOR · UCLA / Jonsson Comprehensive Cancer Center
Who to contact
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Eligibility criteria
Inclusion
Male or female \>= 18 years of age and willing and able to provide informed consent
Previously untreated cytologically or histologically confirmed pancreatic adenocarcinoma with one of the following:
Borderline resectable disease. There are multiple definitions of borderline resectable PDAC including the MD Anderson definition and the criteria developed during the Consensus Conference sponsored by the American Hepato-Pancreato-Biliary Association, Society of Surgical Oncology, and Society for Surgery of the Alimentary Tract. Borderline resectable PDAC cases will be identified per the definition developed in the currently running inter-group pilot trial for borderline resectable pancreatic cancer (NCT01821612). Per this trial, borderline resectable PDAC is defined as the presence of any one or more of the following on CT;
An interface between the primary tumor and the superior mesenteric vein or portal vein (SMV-PV) measuring \>= 180 degrees of the circumference of the vessel wall
Short-segment occlusion of the SMV-PV with normal vein above and below the level of obstruction that is amenable to resection and venous reconstruction
Short segment interface (of any degree) between tumor and hepatic artery with normal artery proximal and distal to the interface that is amenable to resection and reconstruction
An interface between the tumor and SMA measuring \< 180 degrees of the circumference of the vessel wall
Locally advanced disease. Multiple guidelines defining locally advanced PDAC have been developed, including the MD Anderson definition, the National Comprehensive Cancer Network (NCCN) definition, as well as the criteria developed during the Consensus Conference sponsored by the American Hepato-Pancreato-Biliary Association, Society of Surgical Oncology, and Society for Surgery of the Alimentary Tract. Locally advanced PDAC cases will be identified per the definition developed by the Alliance for Clinical Trials in Oncology. Per this definition, locally advanced PDAC is defined as presence of any one or more of the following on CT;
Occlusion of the SMV-PV that is not amenable to resection and venous reconstruction
Interface between tumor and hepatic artery that is not amenable to resection and reconstruction
Interface between the tumor and SMA measuring \> 180 degrees of the circumference of the vessel wall
Interface between the tumor and celiac axis measuring \> 180 degrees of the circumference of the vessel wall
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L
Platelets \>= 100 x 10\^9/L
Hemoglobin \>= 9 g/dL
Serum creatinine (sCr) =\< 1.5 x upper limit of normal (ULN) or Creatinine clearance (Ccr) \>= 40 mL/min (as calculated by Modified Cockcroft-Gault formula)
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (AST/\[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X ULN
Women with no childbearing potential because of surgery or who are at least 1 year postmenopausal (ie, 12 months post last menstrual period) or with menopause confirmed by follicle-stimulating hormone testing
Women of childbearing potential must use an effective nonhormonal method of contraception (intrauterine device or intrauterine system; condom or occlusive cap \[diaphragm or cervical or vault caps\] with spermicidal foam or gel or film or cream or suppository; or vasectomized male partner if he is the sole partner of that participant) for the duration of the study and for up to 6 months after the last dose of zimberelimab or quemliclustat
Male participants must use an effective method of contraception (condom or occlusive cap \[diaphragm or cervical or vault caps\] with spermicidal foam or gel or film or cream or suppository, or vasectomy) throughout the study and for up to 6 months after the last dose of zimberelimab or quemliclustat
Immunosuppressive doses of systemic medications, such as corticosteroids or absorbed topical corticosteroids (doses \> 10 mg/day prednisone or equivalent) must be discontinued at least 2 weeks (14 days) before study treatment administration. Physiologic doses of corticosteroids (=\< 10 mg/day of prednisone or its equivalent) or short pulses of corticosteroids (=\< 3 days) may be permitted
Prior surgery that required general anesthesia or other major surgery as defined by the Investigator must be completed at least 4 weeks before study treatment administration. Surgery requiring regional/epidural anesthesia must be completed at least 72 hours before study treatment administration. Participants should have recovered from the surgical procedure prior to the first dose being administered
Exclusion
Recurrent or metastatic pancreatic adenocarcinoma
Peripheral neuropathy \> grade 2
Known status of human immunodeficiency virus (HIV) which is not well-controlled (CD4 \<300) at the time of study eligibility. Patients with controlled and treated HIV/Hepatitis C virus (HCV) and an undetectable viral load are allowed
Untreated Hepatitis B infection: Patient has known active hepatitis B virus (HBV) or hepatitis C virus (HCV), or Human immunodeficiency virus (HIV) infection (testing is not mandatory, unless required by local regulation)
Participants with resolved or treated HCV (ie, HCV antibody positive but undetectable HCV ribonucleic acid \[RNA\]) will not be excluded from this study
Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of Investigational products (IPs) hazardous, including but not limited to:
Interstitial lung disease, including history of interstitial lung disease or non-infectious pneumonitis (lymphangitic spread of non-small cell lung cancer (NSCLC) is not disqualifying)
Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of the initiation of the IP
Active infection or antibiotics within 48 hours prior to study screening
Clinically significant cardiovascular disease
A condition or unresolved adverse event (AE) from a prior investigational drug that may obscure the interpretation of toxicity determination or AEs
History of prior solid-organ transplantation
Currently active second primary malignancy or history of malignancy less than 5 years prior to the time of study eligibility (Patients with history of skin cancers excluding melanoma will be eligible for participation)
Serious medical comorbidities such as New York Heart Association Class III/IV cardiac disease, uncontrolled cardiac arrhythmias, myocardial infarction over the past 12 months
Known, existing uncontrolled coagulopathy. Patients who have had a venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation are eligible IF: they are appropriately anticoagulated and have not had a Grade 2 or greater bleeding episode in the 3 weeks before Day 1
Known pregnancy, nursing women or positive pregnancy test. Requirement for women of child-bearing potential (WOCBP): Negative serum pregnancy test at screening and prior to dosing on Cycle 1 Day 1, within 24 hours prior to the start of treatment (minimum sensitivity 25 IU/L or equivalent units of HCG). WOCBP must also have a negative serum or urine pregnancy test every 4 weeks, within 24 hours prior to the start of treatment
Any condition (concurrent disease, infection, or comorbidity) that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of safety data, in the opinion of the investigator
History of trauma or major surgery within 28 days prior to the first dose of IP
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Any active or documented history of autoimmune disease, including but not limited to inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis, within 3 years of the first dose of study treatment, except for the following:
Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders such as vitiligo, or alopecia not requiring systemic therapy, or conditions not expected to recur in the absence of an external trigger
Endocrinopathies where the participant is stable on hormone replacement therapy
History of Hashimoto syndrome within 3 years of the first of study treatment that resolved to hypothyroidism alone
History of a syndrome that required systemic steroids or immunosuppressive medications, except for vitiligo or resolved childhood asthma/atopy. Participants with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study
What this trial measures
- Incidence of adverse events (BPRC Cohort)From baseline measurement to 90 days after the last dose of study treatment.
All safety summaries and analyses will be based upon the Safety Population, as defined in this study protocol, will include all randomized participants who receive at least 1 dose of any study drug. Overall exposure to study drug, the numbers of participants completing each cycle, and the dose intensity will be summarized using descriptive statistics. The number of participants with any dose adjustment will be presented for entire treatment period as well as for each cycle. The number of participants with dose reductions, dose delays, or dose omissions will also be summarized, as will the reasons for dose adjustments. Adverse events (AEs) and serious adverse events (SAEs) will be reported using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 terminology and severity.
- Resection rate (BPRC Cohort)Up to 2 years
Simon's two-stage design will be used to demonstrate the resection rate is greater than 50%.
- Progression free survival (PFS) (LAPC Cohort)Up to 2 years
Descriptive statistics with frequency and proportion will be used to summarize R0 resection rate and PFS. Kaplan-Meier methods will be used to analyze PFS and to generate 95% confidence interval (CI).
- Number of participants who develop clinically relevant pancreatic fistula (BPRC Cohort)Up to 2 years