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

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

Timeline

Start

2022-08-31

Primary completion

2027-05-21

Completion

2027-05-21

Publications

• Background Macedo FI, Ryon E, Maithel SK, Lee RM, Kooby DA, Fields RC, Hawkins WG, Williams G, Maduekwe U, Kim HJ, Ahmad SA, Patel SH, Abbott DE, Schwartz P, Weber SM, Scoggins CR, Martin RCG, Dudeja V, Franceschi D, Livingstone AS, Merchant NB. Survival Outcomes Associated With Clinical and Pathological Response Following Neoadjuvant FOLFIRINOX or Gemcitabine/Nab-Paclitaxel Chemotherapy in Resected Pancreatic Cancer. Ann Surg. 2019 Sep;270(3):400-413. doi: 10.1097/SLA.0000000000003468.
• Background Rahib L, Smith BD, Aizenberg R, Rosenzweig AB, Fleshman JM, Matrisian LM. Projecting cancer incidence and deaths to 2030: the unexpected burden of thyroid, liver, and pancreas cancers in the United States. Cancer Res. 2014 Jun 1;74(11):2913-21. doi: 10.1158/0008-5472.CAN-14-0155.
• Background Katz MH, Pisters PW, Lee JE, Fleming JB. Borderline resectable pancreatic cancer: what have we learned and where do we go from here? Ann Surg Oncol. 2011 Mar;18(3):608-10. doi: 10.1245/s10434-010-1460-y. No abstract available.
• Background VanHouten JP, White RR, Jackson GP. A decision model of therapy for potentially resectable pancreatic cancer. J Surg Res. 2012 May 15;174(2):222-30. doi: 10.1016/j.jss.2011.08.022. Epub 2011 Sep 12.
• Background Ghaneh P, Smith R, Tudor-Smith C, Raraty M, Neoptolemos JP. Neoadjuvant and adjuvant strategies for pancreatic cancer. Eur J Surg Oncol. 2008 Mar;34(3):297-305. doi: 10.1016/j.ejso.2007.07.204. Epub 2007 Oct 22.
• Background Kircher SM, Krantz SB, Nimeiri HS, Mulcahy MF, Munshi HG, Benson AB 3rd. Therapy of locally advanced pancreatic adenocarcinoma: unresectable and borderline patients. Expert Rev Anticancer Ther. 2011 Oct;11(10):1555-65. doi: 10.1586/era.11.125.
• Background Gillen S, Schuster T, Meyer Zum Buschenfelde C, Friess H, Kleeff J. Preoperative/neoadjuvant therapy in pancreatic cancer: a systematic review and meta-analysis of response and resection percentages. PLoS Med. 2010 Apr 20;7(4):e1000267. doi: 10.1371/journal.pmed.1000267.
• Background Evans DB, Varadhachary GR, Crane CH, Sun CC, Lee JE, Pisters PW, Vauthey JN, Wang H, Cleary KR, Staerkel GA, Charnsangavej C, Lano EA, Ho L, Lenzi R, Abbruzzese JL, Wolff RA. Preoperative gemcitabine-based chemoradiation for patients with resectable adenocarcinoma of the pancreatic head. J Clin Oncol. 2008 Jul 20;26(21):3496-502. doi: 10.1200/JCO.2007.15.8634.
• Background Kieler M, Unseld M, Bianconi D, Prager G. Challenges and Perspectives for Immunotherapy in Adenocarcinoma of the Pancreas: The Cancer Immunity Cycle. Pancreas. 2018 Feb;47(2):142-157. doi: 10.1097/MPA.0000000000000970.
• Background Dosset M, Vargas TR, Lagrange A, Boidot R, Vegran F, Roussey A, Chalmin F, Dondaine L, Paul C, Lauret Marie-Joseph E, Martin F, Ryffel B, Borg C, Adotevi O, Ghiringhelli F, Apetoh L. PD-1/PD-L1 pathway: an adaptive immune resistance mechanism to immunogenic chemotherapy in colorectal cancer. Oncoimmunology. 2018 Mar 15;7(6):e1433981. doi: 10.1080/2162402X.2018.1433981. eCollection 2018.
• Background Schmid P, Cortes J, Pusztai L, McArthur H, Kummel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Foukakis T, Fasching PA, Cardoso F, Untch M, Jia L, Karantza V, Zhao J, Aktan G, Dent R, O'Shaughnessy J; KEYNOTE-522 Investigators. Pembrolizumab for Early Triple-Negative Breast Cancer. N Engl J Med. 2020 Feb 27;382(9):810-821. doi: 10.1056/NEJMoa1910549.
• Background Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.
• Background Conroy T, Hammel P, Hebbar M, Ben Abdelghani M, Wei AC, Raoul JL, Chone L, Francois E, Artru P, Biagi JJ, Lecomte T, Assenat E, Faroux R, Ychou M, Volet J, Sauvanet A, Breysacher G, Di Fiore F, Cripps C, Kavan P, Texereau P, Bouhier-Leporrier K, Khemissa-Akouz F, Legoux JL, Juzyna B, Gourgou S, O'Callaghan CJ, Jouffroy-Zeller C, Rat P, Malka D, Castan F, Bachet JB; Canadian Cancer Trials Group and the Unicancer-GI-PRODIGE Group. FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer. N Engl J Med. 2018 Dec 20;379(25):2395-2406. doi: 10.1056/NEJMoa1809775.
• Background Hackert T, Sachsenmaier M, Hinz U, Schneider L, Michalski CW, Springfeld C, Strobel O, Jager D, Ulrich A, Buchler MW. Locally Advanced Pancreatic Cancer: Neoadjuvant Therapy With Folfirinox Results in Resectability in 60% of the Patients. Ann Surg. 2016 Sep;264(3):457-63. doi: 10.1097/SLA.0000000000001850.

Drugs

Indications