BMS-986340 with Chemotherapy for Metastatic Pancreatic Cancer
This study is testing a new combination of treatments for pancreatic cancer that has spread (metastatic) or come back (recurrent). It combines BMS-986340, a monoclonal antibody (a type of protein that can target cancer cells), with nivolumab, gemcitabine, and nab-paclitaxel. Researchers want to see if this combination is safe, what side effects it causes, and how well it works to shrink tumors. You might be able to join if you are 18 or older, have pancreatic adenocarcinoma that has spread or returned, and meet other health criteria. The study aims to find out how many people experience significant side effects and how many see their tumors shrink within six months. The current status of this study is unclear.
- Study design
- This is a Phase II interventional study planning to enroll 43 participants. It is testing a new combination of drugs.
- What's involved
- You would undergo a tissue biopsy, blood and urine sample collection, and CT scans. You would receive gemcitabine and Imzokitug intravenously.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure side effects during the first 28-day cycle and how well the treatment works for up to 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07226856
BMS-986340 in Combination With Nivolumab, Gemcitabine and Nab-paclitaxel for the Treatment of Metastatic and Recurrent Pancreatic Adenocarcinoma
Recruiting
PHASE2Ages 18+InterventionalTreatmentMayo ClinicInvestigator-initiated
~43 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:Biopsy ProcedureBiospecimen CollectionComputed TomographyGemcitabineImzokitugMagnetic Resonance Imaging
At a glance
Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of significant adverse events (AEs) (Safety Run-in)
Measured over During cycle 1 (cycle length = 28 days)
+1 more outcome measured
Conditions
NCT07226856
Where you'd take part
This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Mayo Clinic in Arizona
Scottsdale, Arizonastudy coordinator listed
Recruiting
Mayo Clinic in Florida
Jacksonville, Floridastudy coordinator listed
Recruiting
Mayo Clinic in Rochester
Rochester, Minnesotastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Tanios S. Bekaii-Saab, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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Eligibility criteria
Inclusion
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
Provide written informed consent
Willingness to provide mandatory blood specimens for correlative research
Willingness to provide mandatory tissue specimens for correlative research
Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
Exclusion
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
Psychiatric illness/social situations that would limit compliance with study requirements
Known historical or active infection with hepatitis B, or active infection with hepatitis C (note that subjects with hepatitis C who have been clinically cured, defined as persistent absence of hepatitis C ribonucleic acid \[RNA\] detected by polymerase chain reaction \[PCR\] test in serum 12 weeks after completing antiviral treatment, are eligible for this study)
Active infection or an unexplained fever \> 38.5°C during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, subjects with tumor fever may be enrolled), which in the investigator's opinion might compromise the subject's participation in the study or affect the study outcome
Interstitial lung disease, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies
Peripheral artery disease (e.g. claudication, Leo Buerger's disease)
Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma
Known human immunodeficiency virus (HIV) positive with an acquired immune deficiency syndrome (AIDS)-defining opportunistic infection within the last year, or a current CD4 count \< 350 cells/uL. Participants with HIV are eligible if:
They have received antiretroviral therapy for ≥ 4 weeks prior to the first dose of study treatment
They continue on antiretroviral therapy as clinically indicated while enrolled on study
CD4 counts and viral load are monitored per standard of care by a local health care provider
Prior treatment of PDAC with chemotherapy in the neoadjuvant and/or adjuvant setting, except those where at least 12 months have elapsed since completion of the last dose and no persistent treatment-related toxicities are present
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Other active malignancy ≤ 5 years prior to registration. Participants with any of the following additional malignancies are not excluded:
Malignancies with negligible risk of metastases or death (e.g., risk of death or metastases \< 5% at 5 years) that were treated with curative intent and have not recurred within the past 2 years prior to study day 1
Completely resected basal cell or squamous cell skin cancers, carcinoma in situ (CIS) of the cervix, or ductal CIS of the breast
Malignancies considered to be indolent and never required therapy (immunotherapy, chemotherapy, radiation)
Malignancies treated with hormonal therapy alone
History of myocardial infarction ≤ 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
Prior treatment of pancreatic cancer in the metastatic setting with surgery, radiotherapy, chemotherapy or investigational therapy:
Palliative radiotherapy is permitted
Placement of biliary stent/tube is permitted
Documented serum albumin \< 3 g/dL ≤ 15 days prior to registration
Known history of central nervous system (CNS) metastases
Active, known, or suspected autoimmune disease (type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement)
Systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) ≤ 14 days or other immunosuppressive medications ≤ 30 days prior to registration
Prior therapy with anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-CCR8 antibody
Malignant disease other than that being treated in this study
Receipt of an allogeneic tissue/solid organ transplant
Any other clinically significant disease or comorbidity that may adversely affect the safe delivery of treatment within this trial or may limit compliance with study requirements in the opinion of the Investigator
Known hypersensitivity to BMS-986340 or its metabolites and/or excipients and known hypersensitivity to any component of the regimens, their metabolites and/or excipients being used in the combination therapy cohorts for which the participant is being considered
Unwillingness to follow study related procedures
What this trial measures
- Incidence of significant adverse events (AEs) (Safety Run-in)During cycle 1 (cycle length = 28 days)
Will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
- Objective response rate (Phase II)Up to 6 months
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.