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.
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
Pregnant persons
Nursing persons
Participants of childbearing potential who are unwilling to employ adequate contraception
Minor surgical or interventional procedure
Single group
Biopsy Procedure
Procedure/SurgeryUndergo tissue biopsy
Biospecimen Collection
Procedure/SurgeryUndergo urine and blood sample collection
Computed Tomography
Procedure/SurgeryUndergo CT
Gemcitabine
DrugGiven IV
Imzokitug
Biological/VaccineGiven IV
Magnetic Resonance Imaging
Procedure/SurgeryUndergo brain MRI
Nab-paclitaxel
DrugGiven IV
Nivolumab
Biological/VaccineGiven IV
Incidence of significant adverse events (AEs) (Safety Run-in)
Will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
Objective response rate (Phase II)
Objective response rate (ORR) will be defined as achieving a complete response (CR) or partial response (PR) while on protocol treatment. Will be calculated as the proportion of phase II analysis population patients who achieve objective response per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 criteria. The primary endpoint data becomes evaluable when the patient is off protocol treatment or when the patient has had at least 6 months of treatment (3rd scan), whichever is earlier.
Overall survival (OS)
OS is defined as the time from registration until death due to any cause.
Progression-free survival (PFS)
PFS is defined as the time from registration to documentation of disease progression or death due to any cause, whichever is first. Disease progression will be determined based on RECIST v 1.1 criteria.
Disease control rate (DCR)
Will be defined as achieving CR, PR, or maintaining stable disease for at least 6 weeks (at time of first scan) while on treatment. Objective status will be assessed using RECIST v 1.1 criteria. Disease control rate will be calculated as the proportion of evaluable patients who achieve disease control.
Duration of response (DOR)
Will be defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented, or death if no prior evidence of disease progression.
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