What side effects are associated with this type of intervention?

The combination of zimberelimab (a monoclonal antibody), quemliclustat (an adenosine blocker), and chemotherapy for pancreatic cancer can lead to a range of side effects. Immunotherapy with monoclonal antibodies may cause fatigue, diarrhea, skin rash, and autoimmune conditions. Chemotherapy agents such as oxaliplatin, irinotecan, leucovorin, and fluorouracil commonly result in nausea, vomiting, neutropenia, fatigue, and gastrointestinal issues. When these treatments are combined, patients may experience a cumulative effect of these side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer that involve chemotherapy and immunotherapy. One notable combination is gemcitabine plus nab-paclitaxel, which has shown significant efficacy in clinical trials. Additionally, the FDA has approved pembrolizumab, an anti-PD-1 monoclonal antibody, for various cancers, including pancreatic cancer, particularly in cases with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). While specific adenosine blockers like quemliclustat are still under investigation, the integration of immunotherapy with chemotherapy remains a promising approach in the treatment landscape for pancreatic cancer.

What other types of research exist?

Promising alternatives for pancreatic cancer treatment in 2024 include: 1) Pembrolizumab combined with chemotherapy, which has shown efficacy in various cancers and is being explored in pancreatic cancer. 2) Nivolumab plus ipilimumab, a combination of immune checkpoint inhibitors that has demonstrated success in other cancers and is under investigation for pancreatic cancer. 3) Targeted therapies like PARP inhibitors (e.g., olaparib) for patients with BRCA mutations, which have shown promise in clinical trials. 4) Novel agents targeting specific genetic mutations or pathways in pancreatic cancer, such as FGFR inhibitors or KRAS inhibitors, which are in various stages of clinical development.

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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

Must not have

Recurrent or metastatic pancreatic adenocarcinoma

- 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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Summary

This trial tests a combination of immune-boosting drugs and chemotherapy for patients with difficult-to-treat pancreatic cancer. The treatment aims to enhance the immune system and kill cancer cells more effectively than chemotherapy alone.

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.

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.

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 below

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You have been diagnosed with pancreatic cancer for the first time and it has been confirmed by a medical test.

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You have a blockage in a vein called the SMV-PV that cannot be surgically removed or repaired.

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The tumor is in a position that cannot be removed or fixed in the liver's blood vessels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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You have a serious heart condition that could affect your participation in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events (BPRC Cohort)

Progression free survival (PFS) (LAPC Cohort)

Resection rate (BPRC Cohort)

Secondary study objectives

Objective response rate (ORR)

Overall survival (OS)

Trial 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

Core Biopsy

2013

N/A

~130

Fluorouracil

2014

Completed Phase 3

~11700

Irinotecan

2017

Completed Phase 3

~2580

Leucovorin

2005

Completed Phase 4

~6010

Leucovorin Calcium

2011

Completed Phase 3

~12500

Oxaliplatin

2011

Completed Phase 4

~2890

Zimberelimab

2018

Completed Phase 1

~50

Biospecimen Collection

2004

Completed Phase 3

~2020

Computed Tomography

2017

Completed Phase 2

~2740

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for pancreatic cancer often involve a combination of chemotherapy and immunotherapy. Chemotherapy drugs like oxaliplatin, irinotecan, leucovorin, and fluorouracil work by killing cancer cells, stopping their division, or preventing their spread. Immunotherapy with monoclonal antibodies, such as zimberelimab, helps the immune system recognize and attack cancer cells. Quemliclustat, an adenosine blocker, reduces adenosine levels, which can otherwise suppress the immune response against cancer. This combination is significant for pancreatic cancer patients as it aims to enhance the immune system's ability to target cancer cells while directly inhibiting their growth and spread, potentially leading to more effective treatment outcomes.