Ignite Creation Date:
2024-05-06 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05132504
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2021-10-27
Brief Title:
Neoadjuvant Folfirinox Combined With Pembrolizumab Followed by Surgery for Patients With Resectable Pancreatic Cancer
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
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
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 35 Years Duration of Participation16 months Estimated average length of treatment per patient 16 months
Detailed 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 BF and Schell MJ 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
Toxicities will be continuously monitored using the method proposed by Ivanova et al Ivanova A Qaqish BF and Schell MJ 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None