OncoMatch/Clinical Trials/NCT07226856
BMS-986340 in Combination With Nivolumab, Gemcitabine and Nab-paclitaxel for the Treatment of Metastatic and Recurrent Pancreatic Adenocarcinoma
Is NCT07226856 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Imzokitug and Nivolumab for metastatic pancreatic adenocarcinoma.
Treatment: Gemcitabine · Imzokitug · Nab-paclitaxel · Nivolumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Disease stage
Required: Stage IV (AJCC 8th edition 2018)
Metastatic disease required
Initial diagnosis of metastatic or recurrent disease (per American Joint Committee on Cancer 8th Edition [AJCC 8th edition 2018])
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy (neoadjuvant/adjuvant)
Exception: at least 12 months have elapsed since completion of the last dose and no persistent treatment-related toxicities are present
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
Cannot have received: anti-PD-1 therapy
Prior therapy with anti-PD-1
Cannot have received: anti-PD-L1 therapy
Prior therapy with anti-PD-L1
Cannot have received: anti-CTLA-4 therapy
Prior therapy with anti-CTLA-4
Cannot have received: anti-CCR8 antibody
Prior therapy with anti-CCR8 antibody
Cannot have received: chemotherapy, surgery, radiotherapy, or investigational therapy for metastatic pancreatic cancer
Exception: palliative radiotherapy and placement of biliary stent/tube are permitted
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
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL (≤ 15 days prior to registration) (transfusion to achieve this level is not permitted prior to registration); WBC ≥ 2000/uL (≤ 15 days prior to registration); 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)
Kidney function
Calculated creatinine clearance ≥ 40 ml/min using the Cockcroft-Gault formula (≤ 15 days prior to registration)
Liver function
Total bilirubin ≤ 1.5 x ULN (≤ 15 days prior to registration) except in patients with documented Gilbert's syndrome, who must have a total bilirubin ≤ 3 x ULN; AST and ALT ≤ 3.0 x ULN for patients with no concurrent liver metastases, OR ≤ 5.0 x ULN for patients with concurrent liver metastases (≤ 15 days prior to registration)
Cardiac function
Electrocardiogram (ECG) without any clinically significant findings (QTcF ≤ 450 msec and no known arrhythmias) and per the investigator's assessment; Prothrombin time (PT)/INR/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
Hemoglobin ≥ 9.0 g/dL (≤ 15 days prior to registration) (transfusion to achieve this level is not permitted prior to registration); WBC ≥ 2000/uL (≤ 15 days prior to registration); 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 ULN (≤ 15 days prior to registration) except in patients with documented Gilbert's syndrome, who must have a total bilirubin ≤ 3 x ULN; AST and ALT ≤ 3.0 x ULN for patients with no concurrent liver metastases, OR ≤ 5.0 x ULN for patients with concurrent liver metastases (≤ 15 days prior to registration); Prothrombin time (PT)/INR/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); Electrocardiogram (ECG) without any clinically significant findings (QTcF ≤ 450 msec and no known arrhythmias) and per the investigator's assessment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Arizona · Scottsdale, Arizona
- Mayo Clinic in Florida · Jacksonville, Florida
- Mayo Clinic in Rochester · Rochester, Minnesota
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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