Study on BMS-986340 with Nivolumab, Gemcitabine, and Nab-paclitaxel for Treating Advanced Pancreatic Cancer

Sponsor: Mayo Clinic

Sponsor score: 60

ClinicalTrials ID:NCT07226856

This clinical trial is testing a new combination of drugs, including BMS-986340, to see if they are safe and effective in treating pancreatic cancer that has spread or returned after treatment. The study aims to find the best dose and understand the side effects of this treatment.

Patient Parameters

Program Overview

This phase II study is exploring a new treatment for pancreatic cancer that has either spread to other parts of the body or returned after initial treatment. The treatment combines BMS-986340, a monoclonal antibody, with other drugs like nivolumab, gemcitabine, and nab-paclitaxel. These drugs work together to help the immune system attack cancer cells and stop them from growing. The study will assess the safety, side effects, and best dose of this combination to see if it can effectively treat advanced pancreatic cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of pancreatic adenocarcinoma.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have measurable cancer according to standard criteria.
  • Have been initially diagnosed with metastatic or recurrent pancreatic cancer.
  • Have a normal heart rhythm and no significant heart issues.
  • Have adequate blood cell counts and organ function, including:
    • Hemoglobin level of at least 9.0 g/dL without recent transfusions.
    • White blood cell count of at least 2000/uL.
    • Neutrophil count of at least 1500/mm^3 without growth factors.
    • Platelet count of at least 100,000/mm^3 without transfusions.
    • Liver enzymes and bilirubin levels within specified limits.
    • Normal blood clotting times unless on stable anticoagulation.
    • Kidney function within specified limits.
  • Women of childbearing potential must have a negative pregnancy test before starting the study.
  • Agree to provide blood and tissue samples for research purposes.
  • Willing to return for follow-up visits during the study.

Exclusion Criteria

  • Women who are pregnant or breastfeeding, or those who cannot use effective contraception.
  • Have not fully recovered from previous treatments or surgeries.
  • Have serious health conditions that could interfere with the study.
  • Have uncontrolled illnesses, such as active infections or heart problems.
  • Have a history of certain lung diseases or multiple allergies.
  • Have a different type of pancreatic cancer than the one being studied.
  • Have HIV with certain complications or low CD4 counts.
  • Have had other cancers within the last five years, except for certain non-threatening types.
  • Have had a heart attack or severe heart failure recently.
  • Have received certain treatments for pancreatic cancer recently.
  • Have low serum albumin levels.
  • Have known brain metastases.
  • Have active autoimmune diseases requiring treatment.
  • Are taking high doses of steroids or other immunosuppressive drugs.
  • Have had previous treatments with certain immune therapies.
  • Have received an organ transplant.
  • Have allergies to the study drugs or their components.
  • Are unwilling to follow study procedures.

Locations

FACILITYZIPCITYSTATE
Mayo Clinic in Arizona85259ScottsdaleArizona
Mayo Clinic in Florida32224-9980JacksonvilleFlorida
Mayo Clinic in Rochester55905RochesterMinnesota

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