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Immunotherapy + Chemotherapy for Pancreatic Cancer
Phase 1 & 2
Waitlist Available
Led By Zev A Wainberg
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Previously untreated cytologically or histologically confirmed pancreatic adenocarcinoma with one of the following:
-- Occlusion of the SMV-PV that is not amenable to resection and venous reconstruction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial tests if a combination of immunotherapy, adenosine blocker and chemotherapy can treat pancreatic cancer.
Who is the study for?
Adults with borderline resectable or locally advanced pancreatic adenocarcinoma, who have not been treated before and are in good physical condition (ECOG 0-1). They must have adequate blood counts, organ function, and agree to use effective contraception. Excluded are those with severe neuropathy, active infections requiring IV treatment within 14 days of the trial start, uncontrolled medical conditions, recent major surgery or trauma within 28 days prior to first dose of study drug, known poorly-controlled HIV/HBV/HCV infection or other serious comorbidities.Check my eligibility
What is being tested?
The trial is testing a combination therapy for pancreatic cancer that includes zimberelimab (an immunotherapy drug), quemliclustat (a blocker for adenosine which may improve immune response against cancer), and chemotherapy drugs like oxaliplatin and irinotecan. The goal is to see if this combo works better than chemotherapy alone at killing cancer cells.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system attacking normal organs (autoimmune reactions), infusion-related reactions from the drugs being administered into the bloodstream, fatigue from energy depletion due to treatment, digestive issues such as nausea or diarrhea caused by chemotherapy drugs affecting rapidly dividing cells in the gut lining.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have been diagnosed with pancreatic cancer for the first time and it has been confirmed by a medical test.
Select...
You have a blockage in a vein called the SMV-PV that cannot be surgically removed or repaired.
Select...
The tumor is in a position that cannot be removed or fixed in the liver's blood vessels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events (BPRC Cohort)
Number of participants who develop clinically relevant pancreatic fistula (BPRC Cohort)
Progression free survival (PFS) (LAPC Cohort)
+1 moreSecondary outcome measures
Change in CA 19-9 levels
Objective response rate (ORR)
Overall survival (OS)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (zimberelimab, quemliclustat, chemotherapy)Experimental Treatment10 Interventions
Patients receive zimberelimab IV, quemliclustat IV, oxaliplatin IV, leucovorin calcium IV, and inrinotecan IV on study. Patients undergo collection of blood samples and CT throughout the trial. Patients with borderline-resectable pancreatic cancer undergo collection of tissue samples. Patients with locally advanced pancreatic cancer undergo core biopsy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan
2017
Completed Phase 4
~2680
Oxaliplatin
2011
Completed Phase 4
~2560
Leucovorin
2005
Completed Phase 4
~5730
Core Biopsy
2013
N/A
~130
Leucovorin Calcium
2011
Completed Phase 3
~12310
Zimberelimab
2018
Completed Phase 1
~50
Fluorouracil
2014
Completed Phase 3
~11540
Biospecimen Collection
2004
Completed Phase 2
~1730
Computed Tomography
2017
Completed Phase 2
~2720
Find a Location
Who is running the clinical trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
359 Previous Clinical Trials
25,976 Total Patients Enrolled
Arcus Biosciences, Inc.Industry Sponsor
41 Previous Clinical Trials
6,010 Total Patients Enrolled
Zev A WainbergPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
1 Previous Clinical Trials
36 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with pancreatic cancer for the first time and it has been confirmed by a medical test.The tumor in your body is connected to an important blood vessel in a way that covers at least half of the vessel's surface.You have type 1 diabetes, hypothyroidism that only needs hormone replacement, or certain skin disorders.The tumor is in a position that cannot be removed or fixed in the liver's blood vessels.You have a medical condition or side effects from a previous experimental drug that could make it difficult to understand the new drug's effects or side effects.You currently have another type of cancer, or had cancer less than 5 years ago (except for non-melanoma skin cancers).You have a blockage in a specific vein that can be surgically removed and repaired.The tumor is wrapped around the celiac axis blood vessel by more than half.If you had a previous Hepatitis C infection but it has been treated successfully, you can still participate in this study.You have a serious heart condition that could affect your participation in the study.You have a blockage in a vein called the SMV-PV that cannot be surgically removed or repaired.You have a history of lung disease that is not caused by an infection.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (zimberelimab, quemliclustat, chemotherapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this research endeavor still available?
"Data hosted on clinicaltrials.gov demonstrates that this particular medical study is presently not looking for new candidates, with the original posting date being 31st January 2023 and the latest update 13th of same month. However, there are 768 other trials requiring volunteers at present."
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