A Pilot Study of Zimberelimab and Quemliclustat Combination With Chemotherapy in Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma
Jonsson Comprehensive Cancer Center
Summary
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.
Description
PRIMARY OBJECTIVES: I. To evaluate the safety, tolerability and resection rate (for borderline resectable pancreatic cancer \[BRPC\] cohort) or progression free survival (PFS) (for locally advanced pancreatic cancer \[LAPC\] cohort) in patients with borderline resectable pancreatic cancer (BRPC) or locally advanced pancreatic cancer (LAPC) treated with modified fluorouracil, irinotecan, leucovorin and oxaliplatin (mFOLFIRINOX), quemliclustat, and zimberelimab. II. To evaluate development of clinically relevant pancreatic fistula (for BRPC cohort) in the post-operative period after neoadjuvan…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 b…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of blood and tissue samples
- ProcedureComputed Tomography
Undergo a CT scan
- ProcedureCore Biopsy
Undergo core biopsy
- DrugFluorouracil
Given IV
- DrugIrinotecan
Given IV
- DrugLeucovorin
Given IV
- DrugLeucovorin Calcium
Given IV
Location
- Yonemoto,LisaLos Angeles, California