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

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT05132504
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab will be initiated starting with the Cycle 2 Day 1 and will be administered every 6 weeks with a max amount of 9 cycles throughout the study.
  • Folfirinox — DRUG
    Once eligibility has been confirmed and the patient has been registered to the study, the patient will begin induction modified FOLFIRINOX (Oxaliplatin, Leucovorin, Irinotecan, 5-Fluorouracil) chemotherapy treatment. Each cycle is 14 days; a total of six cycles will be administered. Patients will receive growth factor support at the discretion of treating physician.

Study Details

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

Key Dates

Start date
Aug 31, 2022
Status verified
Jul 2025
Primary completion
May 21, 2027
Completion
May 21, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant Folfirinox and Pembrolizumab followed by sx for patients with pancreatic cancer
    Patients will receive 6 cycles of Folfirinox (Oxaliplatin 85 mg/m2, Leucovorin 400 mg/m2, Irinotecan 150 mg/m2, 5-Fluorouracil 2,400 mg/m2) with 2 cycles of Pembrolizumab 400 mg before surgical resection. Following surgery patients will receive 5-Fluorouracil based chemotherapy for up to 6 cycles with 7 more cycles of Pembrolizumab. Patients will receive a total of 9 doses of Q6week cycles of Pembrolizumab.

Primary Outcome Measure

Determine if the neoadjuvant FOLFIRINOX chemotherapy followed by pembrolizumab followed by surgery will improve the overall response rate (ORR) for patients with localized, resectable adenocarcinoma of the pancreas. [ Time Frame: 3 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Baylor College of MedicineHoustonTexas77030
Ernest R. Camp, M.D., M.S.C.R., F.A.C.S.
[email protected]
713-798-7828
Benjamin Musher, M.D.
[email protected]
713-798-4292
Ernest R Camp, M.D., M.S.C.R., F.A.C.S. (PRINCIPAL_INVESTIGATOR)
Baylor St. Luke's Medical Center (BSLMC).HoustonTexas77030
Ernest R. Camp, M.D., M.S.C.R., F.A.C.S.
[email protected]
713-798-7828
Benjamin Musher, M.D.
[email protected]
713-798-4292
Ernest R. Camp, M.D., M.S.C.R., F.A.C.S. (PRINCIPAL_INVESTIGATOR)
Houston Methodist HospitalHoustonTexas77030
Safiya Joseph, CRC
[email protected]
346-238-2420
Nestor F Esnaola, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Baylor College of Medicine· Houston, TXBaylor St. Luke's Medical Center (BSLMC).· Houston, TXHouston Methodist Hospital· Houston, TX

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