Actively Recruiting
BMS-986340 in Combination With Nivolumab, Gemcitabine and Nab-paclitaxel for the Treatment of Metastatic and Recurrent Pancreatic Adenocarcinoma
Led by Mayo Clinic · Updated on 2025-12-22
43
Participants Needed
3
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
BMS-986340 in Combination With Nivolumab, Gemcitabine and Nab-paclitaxel for the Treatment of Metastatic and Recurrent Pancreatic Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed pancreatic adenocarcinoma
- ECOG performance status of 0 or 1
- Measurable disease per RECIST v1.1
- Initial diagnosis of metastatic or recurrent pancreatic cancer per AJCC 8th edition
- ECG with QTcF 450 msec and no known arrhythmias
- Hemoglobin 9.0 g/dL without recent transfusion
- White blood cell count 2000/uL
- Absolute neutrophil count 1500/mm3, stable off growth factors
- Platelet count 100,000/mm3 without recent transfusion
- Total bilirubin 1.5 x ULN or 3 x ULN if Gilbert's syndrome
- AST and ALT 3 x ULN without liver metastases or 5 x ULN with liver metastases
- Coagulation tests (PT/INR/aPTT) 1.5 x ULN or within target range if on anticoagulants
- Creatinine clearance 40 ml/min
- Negative pregnancy test within 8 days for those of childbearing potential
- Provide written informed consent
- Willing to provide mandatory blood and tissue samples
- Willing to return to the enrolling institution for follow-up during active monitoring
You will not qualify if you...
- Pregnant or nursing persons
- Persons unwilling to use adequate contraception if of childbearing potential
- Not fully recovered from recent surgical procedures (minor or major within specified time frames)
- Severe concurrent illness or conditions interfering with safety assessment
- Uncontrolled infections or illnesses including recent heart failure, unstable angina, arrhythmias, recent myocardial infarction
- Dyspnea at rest requiring continuous oxygen
- Psychiatric or social conditions limiting study compliance
- Active or recent hepatitis B or active hepatitis C infection (unless clinically cured)
- Active infection or unexplained fever above 38.56C during screening or dosing
- Lung diseases like interstitial lung disease or pulmonary hypersensitivity
- Peripheral artery disease
- Neuroendocrine or acinar pancreatic carcinoma
- HIV positive with recent opportunistic infection or low CD4 count unless stable on therapy
- Prior chemotherapy for pancreatic cancer within 12 months or with persistent toxicities
- Receiving other investigational agents for pancreatic cancer
- Other active malignancy within 5 years except certain low-risk cancers
- History of myocardial infarction or heart failure within 6 months
- Prior metastatic pancreatic cancer treatment except palliative radiotherapy or biliary stent
- Low serum albumin below 3 g/dL
- Known CNS metastases
- Active or suspected autoimmune disease except hypothyroidism requiring hormone replacement
- Recent systemic corticosteroid or immunosuppressive treatment
- Prior therapy with anti-PD-1, anti-PD-L1, anti-CTLA-4, or anti-CCR8 antibodies
- Malignant diseases other than pancreatic cancer being treated
- Receipt of allogeneic tissue or organ transplant
- Hypersensitivity to study drugs or their components
- Unwillingness to comply with study procedures
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
3
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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