RecruitingPhase 2NCT07226856

BMS-986340 in Combination With Nivolumab, Gemcitabine and Nab-paclitaxel for the Treatment of Metastatic and Recurrent Pancreatic Adenocarcinoma

Phase 2, Single-Arm Trial of BMS-986340 in Combination With Nivolumab, Gemcitabine and Nab-Paclitaxel in the First Line Setting of Advanced Pancreatic Adenocarcinoma


Sponsor

Mayo Clinic

Enrollment

43 participants

Start Date

Dec 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests the safety, side effects and best dose of BMS-986340 in combination with nivolumab, gemcitabine, and nab-paclitaxel and how well it works in treating patients with pancreatic adenocarcinoma that has spread from where it first started (primary site) to other places in the body (metastatic) or that has come back after a period of improvement (recurrent). BMS-986340 is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid and may kill tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. Giving BMS-986340 in combination with nivolumab, gemcitabine, and nab-paclitaxel may be safe, tolerable, and/or effective in treating patients with metastatic or recurrent pancreatic adenocarcinoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called BMS-986340 combined with immunotherapy (nivolumab) and standard chemotherapy for people with metastatic or recurrent pancreatic cancer that has returned or spread. It is a phase I/II trial to evaluate safety and effectiveness. **You may be eligible if...** - You have been confirmed to have pancreatic adenocarcinoma (the most common type of pancreatic cancer) - Your cancer has spread or come back - You have not received prior treatment for metastatic disease - You are in reasonably good health (ECOG status 0 or 1) - You are 18 or older with adequate blood counts and organ function **You may NOT be eligible if...** - Your cancer has not spread or is not recurrent - You have already received treatment for metastatic pancreatic cancer - You have significant heart rhythm problems - You have very low blood counts or poor organ function - You have active autoimmune disease requiring treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy Procedure

Undergo tissue biopsy

PROCEDUREBiospecimen Collection

Undergo urine and blood sample collection

PROCEDUREComputed Tomography

Undergo CT

DRUGGemcitabine

Given IV

BIOLOGICALImzokitug

Given IV

PROCEDUREMagnetic Resonance Imaging

Undergo brain MRI

DRUGNab-paclitaxel

Given IV

BIOLOGICALNivolumab

Given IV


Locations(3)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

View Full Details on ClinicalTrials.gov

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NCT07226856


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