Pilot Study of Gut Microbiome Modulation to Enable Efficacy of Neoadjuvant Checkpoint-based Immunotherapy Following Chemotherapy in Pancreatic Adenocarcinoma

NCT05462496 Phase 2 RECRUITING

A multi-institutional, single arm pilot study of antibiotics and pembrolizumab, following chemotherapy for the treatment of surgically resectable pancreatic cancer.

Details

Lead sponsor	Icahn School of Medicine at Mount Sinai
Phase	Phase 2
Status	RECRUITING
Enrolment	25
Start date	2023-03-16
Completion	2028-04

Conditions

• Pancreatic Cancer

Interventions

• Biopsy
• FOLFIRINOX
• Ciprofloxacin
• Metronidazole
• Pembrolizumab
• Surgical Resection

Primary outcomes

• Achievement of overall immune response — at day 43
  Achievement of overall immune response, defined as activation of one or more of the following T cell markers: HLA-DR, CD38, CD25, KI67, and CD69; activation is defined as an increase of 20% or more over baseline in percentage of T cells expressing the marker. Comparison to be made between tissue biopsy taken following chemotherapy (and prior to antibiotics and pembrolizumab) and definitive surgical specimen.
• Achievement of overall immune response — day 102
  Achievement of overall immune response, defined as activation of one or more of the following T cell markers: HLA-DR, CD38, CD25, KI67, and CD69; activation is defined as an increase of 20% or more over baseline in percentage of T cells expressing the marker. Comparison to be made between tissue biopsy taken following chemotherapy (and prior to antibiotics and pembrolizumab) and definitive surgical specimen.

Countries

United States