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OncoMatch/Clinical Trials/NCT05132504

Neoadjuvant Folfirinox Combined With Pembrolizumab Followed by Surgery for Patients With Resectable Pancreatic Cancer

Is NCT05132504 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Folfirinox for pancreatic ductal adenocarcinoma.

Phase 2RecruitingBaylor College of MedicineNCT05132504Data as of Jun 2026

Treatment: Pembrolizumab · FolfirinoxAbbreviated Title: Neoadjuvant FOLFIRINOX combined with Pembrolizumab followed by surgery for patients with resectable pancreatic cancer Trial Phase: Phase II Clinical Indication: Pancreatic ductal adenocarcinoma; Adenocarcinoma; AJCC I, II, or III; 1st Line neoadjuvant Trial Type: Interventional prospective Type of control: Historical Route of administration: IV Treatment Groups: Neoadjuvant FOLFIRINOX combined with Pembrolizumab followed by surgery for patients with resectable pancreatic cancer Number of trial participants: 30 Estimated enrollment period: 24 months Estimated duration of trial: 3.5 Years Duration of Participation:16 months Estimated average length of treatment per patient: 16 months

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Pembrolizumab

Other

Folfirinox

Cancer type

Pancreatic Cancer

Disease stage

Required: Stage LOCALIZED, POTENTIALLY RESECTABLE

Excluded: Stage BORDERLINE RESECTABLE, III, ADVANCED METASTATIC

localized adenocarcinoma of the pancreas that is potentially resectable

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: chemotherapy

Patient must not have received prior chemotherapy or radiation for pancreatic cancer.

Cannot have received: radiation therapy

Patient must not have received prior chemotherapy or radiation for pancreatic cancer.

Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy

Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).

Lab requirements

Blood counts

absolute neutrophil count (anc) ≥1500/μl; platelets ≥100 000/μl; hemoglobin ≥9.0 g/dl or ≥5.6 mmol/l

Kidney function

creatinine ≤1.5 × uln or ≥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 (≤5 × uln for participants with liver metastases)

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

US trial sites

  • Baylor College of Medicine · Houston, Texas
  • Baylor St. Luke's Medical Center (BSLMC). · Houston, Texas
  • Houston Methodist Hospital · Houston, Texas

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See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT05132504 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

What disease stage is eligible?

Stage LOCALIZED or POTENTIALLY RESECTABLE is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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