Bacteria armed with immune booster takes on tough pancreatic cancer
NCT ID NCT04589234
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This study tests a new treatment called Saltikva, a weakened Salmonella bacteria that carries a human immune-boosting gene (IL-2), in people with metastatic pancreatic cancer. Participants take Saltikva by mouth along with standard chemotherapy. The goal is to see if adding Saltikva helps patients live longer and slows cancer growth. About 60 adults with advanced pancreatic cancer that cannot be removed by surgery are taking part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2020
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must have a histologically confirmed, unresectable metastatic pancreatic adenocarcinoma * Measurable disease will be required * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 * Life expectancy of greater than 16 weeks * Leukocytes \>= 3,000/mcL * Absolute neutrophil count \>= 1,500/mcL * Platelets \>= 100,000/mcL * Total bilirubin =\< 1.5 institutional upper limit of normal (IULN) * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X IULN if no liver metastasis or =\< 5 X IULN if liver metastases are present * Creatinine not to be above IULN OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of Saltikva administration * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients who are receiving any other investigational agents * Patients who are on immunosuppressive medications for any reason including for autoimmune diseases, organ transplantation, or hematologic conditions such as myelodysplastic syndrome. * Patients that require ongoing antibiotics for a prophylactic reason - for example patients with chronic or frequently recurrent urinary tract infections are placed on suppressive or prophylactic antibiotics * Patients with known brain metastases should be excluded from this clinical trial * History of allergic reactions attributed to compounds of similar biologic composition to Saltikva. * Patients with diabetes or in risk for hyperglycemia should not be excluded from trials with Saltikva but the hyperglycemia should be well controlled before the patient enters the trial (glycosylated hemoglobin \[Hba1c\] \< 7.5) * Patients with current evidence of significant cardiovascular disease (New York Heart Association class III or IV cardiac disease), symptomatic congestive heart failure, dilated/hypertrophic or restrictive cardiomyopathy, myocardial infarction (within the past 6 months), unstable angina, unstable arrhythmia or a need for anti-arrhythmic therapy (use of medications for rate control for atrial fibrillation is allowed such as calcium channel blockers and beta-blockers, if stable medication for at least last month prior to initiation of Saltikva. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study; breastfeeding should be discontinued. * Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible. Patients with active Hepatitis B or C infection are ineligble * Clinically significant ascites
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Segal Cancer Centre/ Mortimer B. Davis-Jewish General Hosptial
Montreal, Quebec, H3T 1E2, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a Triple-Drug combo outsmart pancreatic cancer?
- Can removing liver tumors alongside the whipple procedure extend life in stage IV pancreatic cancer?
- Can a One-Two punch of radiation and immunotherapy tame pancreatic cancer?
- Can a Two-Drug immune attack shrink Hard-to-Treat pancreatic tumors?
- Can a targeted antibody give pancreatic cancer chemo a boost?