A Pilot Study of Neoadjuvant mFOLFIRINOX and ELI002-7P Treatment With or Without Tislelizumab in Borderline and Resectable Pancreatic Ductal Adenocarcinoma
Memorial Sloan Kettering Cancer Center
Summary
The researchers are doing this study to find out whether ELI-002 7P in combination with mFOLFIRINOX, with or without tislelizumab, is a safe treatment approach in people who have pancreatic ductal adenocarcinoma (PDAC) with a KRAS mutation. In addition, the researchers are doing this study to find out whether the study treatment is effective against PDAC.
Description
This is an open-label, multi-institution pilot study of neoadjuvant mFOLFIRINOX (5-Fluorouracil, oxaliplatin, leucovorin, irinotecan) and a lipid-conjugated Kristin-Ras (KRAS) therapeutic cancer immunotherapy (ELI-002 7P vaccine), with or without Tislelizumab, in patients diagnosed with resectable or borderline resectable pancreatic ductal adenocarcinoma (PDAC).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: \- Documentation of Disease * Pathologically confirmed adenocarcinoma of the pancreas. * Presence of one of seven KRAS mutations: G12D, G12V, G12R, G12C, G12A, G12S, or G13D. * Definition of Disease * Patients must have resectable or borderline resectable localized disease as defined by NCCN Guidelines v2.2025. Staging CT or MRI of the chest/abdomen/pelvis at enrollment must be negative for metastatic disease. * Prior Treatment * Up to 4 doses of neoadjuvant mFOLFIRINOX are allowed prior to enrollment. Resolution of all toxicities of prior therapy or surgical proced…