Actively Recruiting
Phase 2 Trial of BMS-986340 with Nivolumab, Gemcitabine, and Nab-Paclitaxel for Advanced Pancreatic Adenocarcinoma
Led by Mayo Clinic · Updated on 2025-12-22
43
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, side effects, and best dose of the drug BMS-986340 combined with nivolumab, gemcitabine, and nab-paclitaxel for treating patients with pancreatic adenocarcinoma that has spread or returned after improvement. This phase II trial studies how these treatments may work together to stop tumor growth and spread by using a monoclonal antibody and chemotherapy drugs. Participants receive nivolumab and BMS-986340 intravenously on day 1, along with nab-paclitaxel and gemcitabine given intravenously on days 1 and 15 of each 28-day cycle. Treatment continues for up to 2 years unless the disease worsens or side effects become unacceptable. During the study, patients undergo urine and blood sample collection, tissue biopsies, CT scans, and, if brain metastases are suspected, brain MRI scans. Throughout the trial, researchers monitor safety by tracking significant adverse events during the first treatment cycle and assess tumor response over 6 months. They also measure overall survival, progression-free survival, disease control, and duration of response for up to 2 years. Participants are followed closely with laboratory tests and imaging to evaluate outcomes and side effects while receiving treatment and during follow-up visits.
CONDITIONS
Brief 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
- Histological confirmation of pancreatic adenocarcinoma
- ECOG performance status 0 or 1
- Measurable disease per RECIST v1.1
- Initial diagnosis of metastatic or recurrent disease per AJCC 8th edition
- ECG without significant findings (QTcF ≤ 450 msec, no arrhythmias)
- Hemoglobin ≥ 9.0 g/dL without recent transfusion
- White blood cells ≥ 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 with Gilbert's syndrome
- AST and ALT ≤ 3.0 x ULN without liver metastases or ≤ 5.0 x ULN with liver metastases
- Coagulation tests ≤ 1.5 x ULN or within therapy target if on anticoagulants
- Creatinine clearance ≥ 40 ml/min (Cockcroft-Gault)
- Negative pregnancy test if of childbearing potential
- Provide written informed consent
- Willingness to provide blood and tissue specimens for research
- Willing to return for follow-up during active monitoring phase
You will not qualify if you...
- Pregnant or nursing persons or unwilling to use contraception if of childbearing potential
- Not recovered from recent minor or major surgery (major surgery ≤ 28 days before registration)
- Severe co-morbid illnesses or other disease interfering with safety assessment
- Uncontrolled illness including active infection, recent heart failure or unstable angina, cardiac arrhythmia, recent heart attack, or continuous oxygen need
- Psychiatric or social conditions limiting compliance
- Active or recent hepatitis B or C infection (except clinically cured hepatitis C)
- Fever > 38.5°C or active infection at screening or dosing
- Lung diseases like interstitial lung disease or pulmonary fibrosis
- 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 persistent toxicity
- Receiving other investigational agents for primary cancer
- Other active malignancy within 5 years except certain low-risk cancers
- Recent myocardial infarction or life-threatening heart failure
- Prior metastatic pancreatic cancer treatment except palliative radiotherapy or biliary stenting
- Low serum albumin (< 3 g/dL)
- Known CNS metastases
- Active or suspected autoimmune disease except controlled hypothyroidism
- Recent systemic corticosteroids or immunosuppressive therapy
- Prior treatment with specific immune checkpoint inhibitors
- Malignant disease other than pancreatic cancer
- Allogeneic tissue or organ transplant
- Hypersensitivity to study drugs or components
- Unwillingness to follow study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Cycles repeat every 28 days for up to 2 years
Participants receive treatment with BMS-986340 and nivolumab administered intravenously on day 1, along with nab-paclitaxel and gemcitabine given intravenously on days 1 and 15 of each 28-day cycle. This treatment continues for up to 2 years unless there is disease progression or unacceptable toxicity. Participants also undergo urine and blood sample collection, tissue biopsy, and CT scans throughout the study. Participants with known or suspected brain metastases may have brain MRI scans during the study.
Treatment visits on days 1 and 15 of each 28-day cycle; additional visits for sample collection and imaging throughout the study
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
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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