Trial reportBMC cancer2012
Double-blind, placebo-controlled first in human study to investigate an oral vaccine aimed to elicit an immune reaction against the VEGF-Receptor 2 in patients with stage IV and locally advanced pancreatic cancer.
Trial report in BMC cancer, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01486329 (VXM01 Phase I Dose Escalation Study in Patients With Locally Advanced, Inoperable and Stage IV Pancreatic Cancer to Examine Safety, Tolerability, and Immune Response to the Investigational VEGFR-2 DNA Vaccine VXM01), which is not on this map. Cited by 36 papers.
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.
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.
VXM01 Phase I Dose Escalation Study in Patients With Locally Advanced, Inoperable and Stage IV Pancreatic Cancer to Examine Safety, Tolerability, and Immune Response to the Investigational VEGFR-2 DNA Vaccine VXM01
Who cites it
36 citing papers in PubMed.
- Mucosal immunity: mechanism and application in cancer immunotherapy.Journal of hematology & oncology · 2026Review
- Bacterial engineering for cancer therapy.Nature cancer · 2026Review
- Microbiota in pancreatic ductal adenocarcinoma progression and therapy: The hidden players.Chinese medical journal · 2026Review
- Engineered Bacteria-Nano Hybrid System: The Intelligent Drug Factory for Next-Generation Cancer Immunotherapy.Pharmaceutics · 2025Review
- Design and Efficacy of Oncolytic Viruses and Antitumor Vaccines: A Dead End in the Immunotherapy of Pancreatic Cancer?International journal of molecular sciences · 2025Review
- Review
- Salmonella-based therapeutic strategies: improving tumor microenvironment and bringing new hope for cancer immunotherapy.Medical oncology (Northwood, London, England) · 2024Review
- Genetic engineering ofEcoSal Plus · 2024Review
- Advancing vaccine technology through the manipulation of pathogenic and commensal bacteria.Materials today. Bio · 2024Review
- A Review of Clinical Trials Involving Genetically Modified Bacteria, Bacteriophages and Their Associated Risk Assessments.Applied biosafety : journal of the American Biological Safety Association · 2024Review
- Review
- Current and future immunotherapeutic approaches in pancreatic cancer treatment.Journal of hematology & oncology · 2024Review
- Tumor vaccines: Toward multidimensional anti-tumor therapies.Human vaccines & immunotherapeutics · 2023Review
- Bacterial Drug Delivery Systems for Cancer Therapy: "Why" and "How".Pharmaceutics · 2023Review
- Chemical and Synthetic Biology Approaches for Cancer Vaccine Development.Molecules (Basel, Switzerland) · 2022Review
- Personalized pancreatic cancer therapy: from the perspective of mRNA vaccine.Military Medical Research · 2022Review
- Recombinant AttenuatedCancers · 2022Review
- Article
- Bacteria-Based Synergistic Therapy in the Backdrop of Synthetic Biology.Frontiers in oncology · 2022Review
- Microbiome engineering: engineered live biotherapeutic products for treating human disease.Frontiers in bioengineering and biotechnology · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe investigational oral DNA vaccine VXM01 targets the vascular endothelial growth factor receptor 2 (VEGFR-2) and uses Salmonella typhi Ty21a as a vector. The immune reaction elicited by VXM01 is expected to disrupt the tumor neovasculature and, consequently, inhibit tumor growth. VXM01 potentially combines the advantages of anti-angiogenic therapy and active immunotherapy. METHODS/
designThis phase I trial examines the safety, tolerability, and immunological and clinical responses to VXM01. The randomized, placebo-controlled, double blind dose-escalation study includes up to 45 patients with locally advanced and stage IV pancreatic cancer. The patients will receive four doses of VXM01 or placebo in addition to gemcitabine as standard of care. Doses from 106 cfu up to 1010 cfu of VXM01 will be evaluated in the study. An independent data safety monitoring board (DSMB) will be involved in the dose-escalation decisions. In addition to safety as primary endpoint, the VXM01-specific immune reaction, as well as clinical response parameters will be evaluated. DISCUSSION: The results of this study shall provide the first data regarding the safety and immunogenicity of the oral anti-VEGFR-2 vaccine VXM01 in cancer patients. They will also define the recommended dose for phase II and provide the basis for further clinical evaluation, which may also include additional cancer indications.
trial registrationEudraCT No.: 2011-000222-29, NCT01486329, ISRCTN68809279.
Indexed as
Identifiers
What OpenQuestion holds
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.