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ACTIVE NOT RECRUITING
NCT04589234
PHASE2

Saltikva for Metastatic Pancreatic Cancer

Sponsor: Salspera LLC

View on ClinicalTrials.gov

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

Interventions

DRUG

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

DRUG

FOLFIRINOX Alone (Historical Controls)

We will use historical data from the literature to compare FOLFIRINOX alone against the FOLFIRINOX with Salmonella-IL2 group

DRUG

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