OncoMatch/Clinical Trials/NCT05462496

Modulation of the Gut Microbiome With Pembrolizumab Following Chemotherapy in Resectable Pancreatic Cancer

Is NCT05462496 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including FOLFIRINOX and Ciprofloxacin for pancreatic cancer.

Phase 2RecruitingIcahn School of Medicine at Mount SinaiNCT05462496Data as of May 2026

Treatment: FOLFIRINOX · Ciprofloxacin · Metronidazole · Pembrolizumab — A multi-institutional, single arm pilot study of antibiotics and pembrolizumab, following chemotherapy for the treatment of surgically resectable pancreatic cancer.

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Extracted eligibility criteria

Cancer type

Pancreatic Cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: radiation therapy

Any prior radiation therapy ... for treatment of the patient's pancreatic tumor

Cannot have received: immunotherapy

Any prior ... immunotherapy ... for treatment of the patient's pancreatic tumor

Cannot have received: biologic ('targeted') therapy

Any prior ... biologic ('targeted') therapy for treatment of the patient's pancreatic tumor

Lab requirements

Blood counts

Absolute neutrophil count (ANC) ≥1500/µL; Platelets ≥100,000/µL; Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L (without erythropoietin dependency and without packed red blood cell transfusion within last 2 weeks)

Kidney function

Creatinine ≤1.5 × ULN OR measured or calculated creatinine clearance ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN

Liver function

Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN; AST (SGOT) and ALT (SGPT) ≤2.5 × ULN

Normal organ and marrow function as defined below: ... (see above for full details)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

Icahn School of Medicine at Mount Sinai · New York, New York

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