Evidence map›Paper›PMID 41591505›Full record

Trial reportCancer immunology, immunotherapy : CII2026

A phase 2 study of orally administered live biotherapeutic salmonella-IL2 with FOLFIRINOX for stage IV pancreatic cancer.

Gerald Batist, Petr Kavan, Lance Augustin, Janet Schottel, Jordan Moradian, James T Lee, Daniel Saltzman

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer immunology, immunotherapy : CII, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04589234 (A Phase 2 Study of Saltikva), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04589234 phase2active not recruitingnot on this map

A Phase 2 Study of Saltikva (Attenuated Salmonella Typhimurium Containing the Human Gene for Interleukin-2) in Patients With Metastatic Pancreatic Cancer

TypeinterventionalSponsorSalspera LLCRan2020 to 2030Enrolled60ConditionsMetastatic Pancreatic CancerArmsSalmonella-IL2, FOLFIRINOX Alone (Historical Controls), Gemcitabine/Abraxane Alone (Historical Controls)
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
  2. Article
  3. Optimization Strategies and Synergistic Applications of EngineeredInternational journal of nanomedicine · 2026
    Review
  4. AttenuatedFrontiers in immunology · 2026
    Review
  5. The renaissance ofFrontiers in immunology · 2026
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Gerald BatistSegal Cancer Center, McGill University Center for Translational Research, Jewish General Hospital, Montreal, QC, Canada.
Petr KavanSegal Cancer Center, McGill University Center for Translational Research, Jewish General Hospital, Montreal, QC, Canada.
Lance AugustinDepartment of Surgery, University of Minnesota, Minneapolis, MN, USA.
Janet SchottelDepartment of Surgery, University of Minnesota, Minneapolis, MN, USA.
Jordan MoradianSalspera, Cambridge, MA, USA.
James T LeeDepartment of Surgery, University of Minnesota, Minneapolis, MN, USA.
Daniel SaltzmanDepartment of Surgery, University of Minnesota, Minneapolis, MN, USA. DSaltzman@Salspera.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Salmonella-IL2 is an attenuated Salmonella Typhimurium strain carrying the human gene for IL-2. When orally administered in preclinical trials, the bacterium colonizes tumors and locally releases IL-2, triggering immunologically-mediated tumor cell killing without untoward side effects. A non-randomized, phase 2 study evaluated the combination of Salmonella-IL2 with standard of care (SOC) chemotherapy where patients received Salmonella-IL2 plus FOLFIRINOX (FFX). Overall survival (OS), progression-free survival (PFS), safety, and biomarker data in each arm were studied. In total, 34 patients (30 in the trial, 4 via EAP) were enrolled: 26 received Salmonella-IL2 with FOLFIRINOX. Those patients who received more than five doses of Salmonella-IL2 with FOLFIRINOX (n = 20) had a mPFS of 15 months while the mOS was 20.3 months. Even though there were no complete responses, the partial response rate and the overall response rate was 70.0%. In addition, 41 serious adverse events were noted and attributed to SOC chemotherapy agents but none to Salmonella-IL2. Addition of Salmonella-IL2 to FOLFIRINOX is associated with increased mPFS and mOS when compared to previously reported outcomes with FOLFIRINOX alone in the literature. A multicenter, randomized, phase 3 trial is warranted. ClinicalTrials.gov identifier: NCT04589234.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsInterleukin-2Pancreatic NeoplasmsSalmonella typhimuriumAdministration, OralAdultAgedFemaleFluorouracilHumansIrinotecanLeucovorinMaleMiddle AgedNeoplasm StagingOxaliplatinFluorouracilfolfirinoxInterleukin-2IrinotecanLeucovorinOxaliplatinBacterial Based Cancer TherapyLive Biotherapeutic ProductPancreatic CancerSalmonella-IL2

Identifiers

PMID41591505
PMCPMC12847481

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.