Actively Recruiting
Neoadjuvant Folfirinox Combined With Pembrolizumab Followed by Surgery for Patients With Resectable Pancreatic Cancer
Led by Baylor College of Medicine · Updated on 2025-07-18
30
Participants Needed
3
Research Sites
246 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Abbreviated 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
CONDITIONS
Official Title
Neoadjuvant Folfirinox Combined With Pembrolizumab Followed by Surgery for Patients With Resectable Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years of age or older with confirmed localized, potentially resectable pancreatic adenocarcinoma.
- Adequate imaging (CT or MRI) confirms tumor staging without involvement of the superior mesenteric artery or celiac axis.
- Patent superior mesenteric vein and portal vein with less than 180-degree abutment and no invasion.
- No evidence of distant metastases.
- Female patients of childbearing potential must have a negative pregnancy test within 72 hours before treatment.
- Male participants must agree to use contraception during treatment and for 220 days after last dose.
- No prior chemotherapy or radiation for pancreatic cancer.
- ECOG performance status of 0 or 1.
- Informed consent signed before any study activities.
- Female participants who are not of childbearing potential or agree to use contraception during and for 160 days after treatment.
- Adequate organ function as defined by specific blood counts, kidney and liver function tests performed within 14 days before treatment.
You will not qualify if you...
- Patients with borderline resectable, locally advanced unresectable, or metastatic pancreatic cancer.
- Diagnosis of neuroendocrine tumors, adenosquamous cancer, lymphoma, or ampullary cancer.
- Active uncontrolled infections requiring systemic therapy.
- Known HIV infection.
- Major surgery within 4 weeks prior to registration (except diagnostic procedures).
- Allergy or hypersensitivity to study drugs.
- Serious medical risks making chemotherapy or radiation unsafe.
- Other active malignancies requiring treatment within past 2 years, except certain skin cancers or carcinoma in situ.
- Significant cardiovascular disease within the past year.
- Inability or unwillingness to comply with study procedures.
- Participation in other therapeutic clinical trials.
- Peripheral neuropathy grade 2 or higher.
- Positive pregnancy test in women of childbearing potential within 72 hours before treatment.
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or related immune agents.
- Received live vaccine within 30 days before study drug.
- Use of investigational agents or devices within 4 weeks before treatment.
- Immunodeficiency or recent use of immunosuppressive therapy.
- Active autoimmune disease requiring systemic treatment in past 2 years.
- History or current pneumonitis or interstitial lung disease requiring steroids.
- Known active hepatitis B or C infection.
- Conditions or therapies interfering with study participation.
- Psychiatric or substance abuse disorders interfering with cooperation.
- History of allogenic tissue or solid organ transplant.
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
2
Baylor St. Luke's Medical Center (BSLMC).
Houston, Texas, United States, 77030
Actively Recruiting
3
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Ernest R. Camp, M.D., M.S.C.R., F.A.C.S.
CONTACT
B
Benjamin Musher, M.D.
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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