Study on Cemiplimab and Gemcitabine for Treating Advanced Pancreatic Cancer

Sponsor: University of California, San Diego

Sponsor score: 40

ClinicalTrials ID:NCT06790602

Provider View

This clinical trial is testing a new treatment combining cemiplimab with the chemotherapy drug gemcitabine to see if it can help patients with advanced pancreatic cancer that has spread and has specific genetic changes. The study is for patients who have already tried other standard treatments.

Patient Parameters

Program Overview

The purpose of this Phase 2 study is to evaluate if combining cemiplimab, an immune therapy, with gemcitabine, a standard chemotherapy drug, can effectively treat patients with advanced pancreatic cancer that has spread to other parts of the body. This study focuses on patients whose cancer has specific genetic changes known as SWI/SNF alterations and who have already been treated with other chemotherapy regimens like FOLFIRINOX or gemcitabine/nab-paclitaxel.

Description

This study is exploring a new treatment approach for patients with advanced pancreatic cancer that has spread. The standard treatments for this type of cancer include chemotherapy regimens like FOLFIRINOX or gemcitabine/nab-paclitaxel. However, these treatments can be challenging for patients due to side effects and other health issues. This trial is testing a combination of cemiplimab, an immune therapy, with gemcitabine to see if it can improve outcomes for patients with specific genetic changes in their cancer. These genetic changes, known as SWI/SNF alterations, may make the cancer more responsive to immune therapies. The study aims to determine if this combination can lead to better survival rates and tumor responses compared to past treatments. Participants will receive the combination treatment and be monitored for safety and effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Able to understand the study, follow procedures, and provide written consent.
  • Have a confirmed diagnosis of pancreatic cancer that has spread.
  • Cancer must be at Stage IV and measurable by specific criteria.
  • Have specific genetic changes in the cancer, identified by a test before joining the study.
  • Have received one previous line of chemotherapy for pancreatic cancer.
  • Last chemotherapy dose must have been more than 14 days before starting the study treatment.
  • Last radiation therapy must have been more than 28 days before starting the study treatment.
  • Must be in good general health with a performance score of 0-1.
  • Have adequate blood cell counts and organ function as determined by specific tests.
  • Women of childbearing potential must agree to use effective contraception during the study and for 6 months after the last dose.
  • Men must agree to use condoms or other effective contraception during the study and for 6 months after the last dose.

Exclusion Criteria

  • Have received two or more lines of previous treatment for advanced pancreatic cancer.
  • Have a history of autoimmune disease requiring treatment in the past year.
  • Have had an organ or bone marrow transplant.
  • Have a history of lung disease or recent stroke.
  • Have had another cancer within the past 3 years, except for certain skin cancers.
  • Have previously received immune therapy.
  • Have known bleeding disorders or are currently using certain blood thinners.
  • Are using strong medications that affect liver enzymes.
  • Have cancer that has spread to the brain.
  • Have other serious health conditions that could increase risk or affect study results.
  • Have a life expectancy of less than 3 months.
  • Have active, uncontrolled infections like HIV or hepatitis.
  • Have received a live vaccine within 4 weeks of starting the study.
  • Have significant heart disease or have had a recent heart attack.
  • Have had major surgery within 4 weeks of starting the study.
  • Are pregnant or breastfeeding.
  • Have known allergies to the study drugs.

Locations

FACILITYZIPCITYSTATE
University of California, San Diego92093La JollaCalifornia

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