Study on Zimberelimab and Quemliclustat with Chemotherapy for Treating Pancreatic Cancer That May Be Hard to Remove or Has Spread Locally

Sponsor: Jonsson Comprehensive Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05688215

Provider View

This clinical trial is exploring a new treatment combining zimberelimab and quemliclustat with chemotherapy to see if it can help treat pancreatic cancer that is difficult to remove by surgery or has spread to nearby areas.

Patient Parameters

Program Overview

This study is testing a new combination of treatments for pancreatic cancer that is either borderline resectable (may or may not be removable by surgery) or locally advanced (spread to nearby tissues or lymph nodes). The treatment includes zimberelimab, an immunotherapy drug that helps the immune system attack cancer, and quemliclustat, which blocks a chemical called adenosine that can weaken the immune response. These are combined with chemotherapy drugs (oxaliplatin, irinotecan, leucovorin, and fluorouracil) to see if they can work better together to stop cancer growth.

Description

The main goals of this study are to see if the combination of zimberelimab, quemliclustat, and chemotherapy is safe and can help shrink tumors in patients with pancreatic cancer that is hard to remove or has spread locally. Researchers will also look at how well the treatment works by measuring tumor markers and checking for tumor shrinkage through imaging tests.

Patients will receive the treatment through an IV and will have regular blood tests and CT scans to monitor their progress. Those with borderline resectable cancer will also provide tissue samples, while those with locally advanced cancer will have a core biopsy.

The study will also explore how the treatment affects the tumor environment and immune cells, and whether certain biomarkers can predict how well the treatment will work.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older who can provide informed consent.
  • Have not received prior treatment for pancreatic cancer.
  • Diagnosed with pancreatic cancer that is either borderline resectable or locally advanced, based on specific medical criteria.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Meet specific blood count and organ function requirements.
  • Women must not be able to become pregnant or must use effective contraception during the study and for 6 months after.
  • Men must use effective contraception during the study and for 6 months after.
  • Must not be taking high doses of steroids or other immunosuppressive medications.
  • Must have recovered from any major surgery before starting the study.

Exclusion Criteria

  • Have recurrent or metastatic pancreatic cancer.
  • Have severe nerve damage (peripheral neuropathy) greater than grade 2.
  • Have uncontrolled HIV or untreated hepatitis B or C infections.
  • Have serious medical conditions that could make the study treatment unsafe.
  • Have had another type of cancer within the last 5 years, except for certain skin cancers.
  • Have serious heart conditions or uncontrolled bleeding disorders.
  • Are pregnant or breastfeeding.
  • Have a history of autoimmune diseases that require treatment.
  • Have had major surgery or trauma within 28 days before starting the study.
  • Have psychiatric or substance abuse issues that could interfere with the study.

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