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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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 criteria

Qualifiers

Age ≥ 18 years

Histological confirmation of pancreatic adenocarcinoma

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1

Disqualifiers

Pregnant persons

Nursing persons

Participants of childbearing potential who are unwilling to employ adequate contraception

Minor surgical or interventional procedure

Trial design

Treatments tested in this trial

  • Biopsy Procedure
  • Biospecimen Collection
  • Computed Tomography
  • Gemcitabine
  • Imzokitug
  • Magnetic Resonance Imaging
  • Nab-paclitaxel
  • Nivolumab

Treatment groups

43 Participants
are divided into 1 treatment group

Sponsors and collaborators