Metastatic Pancreatic AdenocarcinomaPhase 2NCT07226856
BMS-986340 in Combination With Nivolumab, Gemcitabine and Nab-paclitaxel for the Treatment of Metastatic and Recurrent Pancreatic Adenocarcinoma
A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Computed Tomography in people with Metastatic Pancreatic Adenocarcinoma and Recurrent Pancreatic Adenocarcinoma, run by Mayo Clinic at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Adenocarcinoma, Recurrent Pancreatic Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v8
- What is being tested?
- Biopsy Procedure, Biospecimen Collection and Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Dec 2025to 28 Feb 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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)
Who cannot join
- 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
Show all 46Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Umair Majeed, MD
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Ryan M. Carr, MD, PhD
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Tanios S. Bekaii-Saab, MD
About this study
Official title: 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
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
- Metastatic Pancreatic Adenocarcinoma, Recurrent Pancreatic Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v8
- Being tested
- Biopsy Procedure, Biospecimen Collection, Computed Tomography, Gemcitabine, Imzokitug
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy ProcedureProcedure or surgery
Also called Biopsy, BIOPSY_TYPE, Bx
Undergo tissue biopsy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo urine and blood sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
GemcitabineDrug
Also called dFdC, dFdCyd, Difluorodeoxycytidine
Given IV
ImzokitugBiological
Also called Anti-CCR8 Monoclonal Antibody BMS-986340, BMS 986340, BMS-986340, BMS986340
Given IV
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo brain MRI
Nab-paclitaxelDrug
Also called ABI 007, ABI-007, ABI007, Abraxane
Given IV
NivolumabBiological
Also called ABP 206, BCD-263, BMS 936558, BMS-936558
Given IV
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Gemcitabine; Biological: Imzokitug; Procedure: Magnetic Resonance Imaging; Drug: Nab-paclitaxel; Biological: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of significant adverse events (AEs) (Safety Run-in)
Will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
Measured: 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.
Measured: Up to 6 months
Secondary outcomes (5)
Overall survival (OS)
OS is defined as the time from registration until death due to any cause.
Measured: Up to 2 years
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.
Measured: Up to 2 years
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.
Measured: Up to 2 years
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.
Measured: Up to 2 years
Incidence of grade 3 or greater AEs
Will be reported using CTCAE v 5.0.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2025
- Study start12 Dec 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tanios S. Bekaii-Saab, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226856
- Sponsor's protocol ID
- MC250402
- Other IDs
- NCI-2025-08032, 25-003418, MC250402
- Status last verified
- Sep 2026
- First submitted
- 7 Nov 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No