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

NCT07226856 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: MC250402NCI-2025-0803225-003418
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Recurrent Pancreatic Adenocarcinoma; Metastatic Pancreatic Adenocarcinoma; Stage IV Pancreatic Cancer AJCC v8

Outcome Measures

Primary Outcomes (2)

• Incidence of significant adverse events (AEs) (Safety Run-in)

  Will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

  During cycle 1 (cycle length = 28 days)

• 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.

  Up to 6 months

Secondary Outcomes (5)

• Overall survival (OS)

  Up to 2 years

• Progression-free survival (PFS)

  Up to 2 years

• Disease control rate (DCR)

  Up to 2 years

• Duration of response (DOR)

  Up to 2 years

• Incidence of grade 3 or greater AEs

  Up to 2 years

Study Arms (1)

Treatment (BMS-986340, nivolumab, gemcitabine, nab-paclitaxel)

EXPERIMENTAL

Patients receive nivolumab IV over 30 minutes and BMS-986340 IV over 60 minutes on day 1, as well as nab-paclitaxel IV over 30-40 minutes and gemcitabine IV over 30 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo urine and blood sample collection, tissue biopsy, and CT throughout the study. Additionally, patients with known or suspected brain metastases may also undergo brain MRI throughout the study.

Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Gemcitabine; Biological: Imzokitug; Procedure: Magnetic Resonance Imaging; Drug: Nab-paclitaxel; Biological: Nivolumab

Interventions

Gemcitabine DRUG

Given IV

Also known as: dFdC, dFdCyd, Difluorodeoxycytidine

Treatment (BMS-986340, nivolumab, gemcitabine, nab-paclitaxel)

Imzokitug BIOLOGICAL

Given IV

Also known as: Anti-CCR8 Monoclonal Antibody BMS-986340, BMS 986340, BMS-986340, BMS986340

Treatment (BMS-986340, nivolumab, gemcitabine, nab-paclitaxel)

Magnetic Resonance Imaging PROCEDURE

Undergo brain MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Treatment (BMS-986340, nivolumab, gemcitabine, nab-paclitaxel)

Nab-paclitaxel DRUG

Given IV

Also known as: ABI 007, ABI-007, ABI007, Abraxane, Albumin-bound Paclitaxel, Albumin-Stabilized Nanoparticle Paclitaxel, Nanoparticle Albumin-bound Paclitaxel, Nanoparticle Paclitaxel, Naveruclif, Paclitaxel Albumin, paclitaxel albumin-stabilized nanoparticle formulation, Paclitaxel Nanoparticle Albumin-bound, Paclitaxel Protein-Bound, Protein-bound Paclitaxel

Treatment (BMS-986340, nivolumab, gemcitabine, nab-paclitaxel)

Nivolumab BIOLOGICAL

Given IV

Also known as: ABP 206, BCD-263, BMS 936558, BMS-936558, BMS936558, CMAB819, MDX 1106, MDX-1106, MDX1106, NIVO, Nivolumab Biosimilar ABP 206, Nivolumab Biosimilar BCD-263, Nivolumab Biosimilar CMAB819, ONO 4538, ONO-4538, ONO4538, Opdivo

Treatment (BMS-986340, nivolumab, gemcitabine, nab-paclitaxel)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Treatment (BMS-986340, nivolumab, gemcitabine, nab-paclitaxel)

Biopsy Procedure PROCEDURE

Undergo tissue biopsy

Also known as: Biopsy, BIOPSY_TYPE, Bx

Treatment (BMS-986340, nivolumab, gemcitabine, nab-paclitaxel)

Biospecimen Collection PROCEDURE

Undergo urine and blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (BMS-986340, nivolumab, gemcitabine, nab-paclitaxel)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Initial diagnosis of metastatic or recurrent disease (per American Joint Committee on Cancer 8th Edition \[AJCC 8th edition 2018\])
• Electrocardiogram (ECG) without any clinically significant findings (QT interval corrected by Fridericia's formula (QTcF) ≤ 450 msec and no known arrhythmias) and per the investigator's assessment
• Hemoglobin ≥ 9.0 g/dL (≤ 15 days prior to registration) (transfusion to achieve this level is not permitted prior to registration)
• White blood cells (WBC) ≥ 2000/uL (≤ 15 days prior to registration)
• Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (≤ 15 days prior to registration) (stable off any growth factor prior to registration)
• Platelet count ≥ 100,000/mm\^3 (≤ 15 days prior to registration) (transfusion to achieve this level is not permitted prior to registration)
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (≤ 15 days prior to registration) except in patients with documented Gilbert's syndrome, who must have a total bilirubin ≤ 3 x ULN
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x institution's upper limit of normal (ULN) for patients with no concurrent liver metastases, OR ≤ 5.0 x institution's ULN for patients with concurrent liver metastases (≤ 15 days prior to registration)
• Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN (≤ 15 days prior to registration) OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy
• Calculated creatinine clearance ≥ 40 ml/min using the Cockcroft-Gault formula (≤ 15 days prior to registration)
• Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only

You may not qualify if:

• Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
• Pregnant persons
• Nursing persons
• Participants of childbearing potential who are unwilling to employ adequate contraception
• Failure to recover from any adverse events related to any of the following therapies received prior to registration:
• Minor surgical or interventional procedure
• Major surgical procedure other than diagnostic surgery, ≤ 28 days prior to registration
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• Uncontrolled intercurrent illness including, but not limited to:
• Ongoing or active infection
• Symptomatic congestive heart failure ≤ 6 months prior to registration
• Unstable angina pectoris ≤ 6 months prior to registration
• Cardiac arrhythmia
• Coronary stenting or myocardial infarction ≤1 year prior to registration
• Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Biopsy; Specimen Handling; Gemcitabine; Magnetic Resonance Spectroscopy; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Taxes; Nivolumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Spectrum Analysis; Chemistry Techniques, Analytical; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Economics; Health Care Economics and Organizations; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins

Study Officials

• Tanios S. Bekaii-Saab, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2025
• First Posted: November 12, 2025
• Study Start: December 12, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-06

Locations

US (3)