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

Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title: Phase II Study of Neoadjuvant Folfirinox Chemotherapy Followed by Pembrolizumab Followed by Surgery for Patients With Localized, Resectable Adenocarcinoma of the Pancreas

Status Recruiting

Clinical Trial Summary

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

Clinical Trial Description

This is a Phase II trial of NEOADJUVANT FOLFIRINOX CHEMOTHERAPY WITH PEMBROLIZUMAB followed by SURGERY and Adjuvant PEMBROLIZUMAB for Patients with LOCALIZED, RESECTABLE Adenocarcinoma of the pancreas. Investigators hypothesize that appropriately timed neoadjuvant FOLFIRINOX with anti-PD-1 mAb (pembrolizumab) can be administered safely and feasibly, and that this combination will lead to improved clinical response associated with enhanced numbers of immune cells in surgically resected pancreatic tumors. Patients will receive 6 cycles of FOLFIRINOX with 2 cycles of PEMBROLIZUMAB before surgical resection. Following surgery patients will receive 5FU 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.

Toxicities will be continuously monitored using the method proposed by Ivanova et al. [Ivanova, A., Qaqish, B.F., and Schell, M.J. (2005). Continuous toxicity monitoring in phase II trials in oncology. Biometrics 61: 540-545.]. The method generates a Pocock-type stopping boundary for repeated testing for toxicity. Sequential boundaries will be used to monitor dose-limiting toxicity rate. The accrual will be halted if excessive numbers of dose-limiting toxicities are seen, that is, if the number of dose-limiting toxicities is equal to or exceeds boundary number out of the number of patients with full follow-up. This is a Pocock-type stopping boundary that yields the probability of crossing the boundary at most 5% when the rate of dose-limiting toxicity is equal to the acceptable rate of 25%. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma

• NCT number: NCT05132504
• Study type: Interventional
• Source: Baylor College of Medicine
• Contact: Ernest R. Camp, M.D., M.S.C.R., F.A.C.S.
• Phone: 713-798-7828
• Email: Ramsay.camp@bcm.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: August 31, 2022
• Completion date: December 31, 2024