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Saltikva for Metastatic Pancreatic Cancer
Sponsor: Salspera LLC
Summary
Objectives: Assess the efficacy of multiple dose oral administration of Saltikva, an attenuated strain of Salmonella Typhimurium expressing IL-2, in patients with metastatic pancreatic cancer on standard chemotherapy (either FOLFIRINOX or Gemcitabine/Abraxane and Saltikva). Study Rationale: The addition of Saltikva to the standard of care regimen for Stage IV metastatic pancreatic cancer will significantly prolong the overall survival and prolong the time to disease progression. Patient Population: unresectable, metastatic pancreatic cancer patients 18 years of age or older
Official title: A Phase 2 Study of Saltikva (Attenuated Salmonella Typhimurium Containing the Human Gene for Interleukin-2) in Patients With Metastatic Pancreatic Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2020-10-20
Completion Date
2030-12-31
Last Updated
2024-04-24
Healthy Volunteers
No
Conditions
Interventions
Salmonella-IL2
Phase 2 study to determine the anti-tumor effectiveness of Salmonella-IL2 (Saltikva) with standard of care chemotherapy (either FOLFIRINOX or Gemcitabine/Abraxane) for metastatic pancreatic cancer
FOLFIRINOX Alone (Historical Controls)
We will use historical data from the literature to compare FOLFIRINOX alone against the FOLFIRINOX with Salmonella-IL2 group
Gemcitabine/Abraxane Alone (Historical Controls)
We will use historical data from the literature to compare Gemcitabine/Abraxane alone against the Gemcitabine/Abraxane with Salmonella-IL2 group
Locations (1)
Segal Cancer Centre/ Mortimer B. Davis-Jewish General Hosptial
Montreal, Quebec, Canada