Evidence map›Paper›PMID 31650066›Full record

ArticleContemporary clinical trials communications2019

First-in-human phase I clinical trial of a combined immune modulatory approach using TetMYB vaccine and Anti-PD-1 antibody in patients with advanced solid cancer including colorectal or adenoid cystic carcinoma: The MYPHISMO study protocol (NCT03287427).

Toan Pham, Lloyd Pereira, Sara Roth, Laura Galletta, Emma Link, Tim Akhurst, Ben Solomon, Michael Michael, Phillip Darcy, Shienny Sampurno and 3 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Contemporary clinical trials communications, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03287427 (First-in-human Phase I Clinical Trial of a Combined Immune Modulatory Approach Using TetMYB Vaccine and Anti-PD1 Antibody in Patients With Advanced Solid Cancer Including Colorectal or Adenoid Cystic Carcinoma.), which is not on this map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
0.8field-weighted citation impact, top 25% of its field
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.

NCT03287427 phase1completednot on this map

First-in-human Phase I Clinical Trial of a Combined Immune Modulatory Approach Using TetMYB Vaccine and Anti-PD1 Antibody in Patients With Advanced Solid Cancer Including Colorectal or Adenoid Cystic Carcinoma.

TypeinterventionalSponsorPeter MacCallum Cancer Centre, AustraliaRan2018 to 2022Enrolled27ConditionsColorectal Cancer, Adenoid Cystic CarcinomaArmsTetMYB Vaccine, BGB-A317
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 26 citations in OpenAlex.

  1. Review
  2. Article
  3. Molecular pathology of adenoid cystic carcinoma.Histology and histopathology · 2025
    Review
  4. Article
  5. Review
  6. Article
  7. Review
  8. Review
  9. Article
  10. Emerging role of MYB transcription factors in cancer drug resistance.Cancer drug resistance (Alhambra, Calif.) · 2024
    Review
  11. Salivary gland pathologies: evolution in classification and association with unique genetic alterations.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2023
    Review
  12. Review
  13. Review
  14. Review
  15. Review
  16. Review
  17. Article
  18. Systemic therapies for salivary gland adenoid cystic carcinoma.American journal of cancer research · 2021
    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

13 authors at 2 institutions in 1 country.

Toan PhamDivision of Cancer Research, Peter MacCallum Cancer Centre, Melbourne, Australia.
Lloyd PereiraDivision of Cancer Research, Peter MacCallum Cancer Centre, Melbourne, Australia.
Sara RothDivision of Cancer Research, Peter MacCallum Cancer Centre, Melbourne, Australia.
Laura GallettaDivision of Cancer Research, Peter MacCallum Cancer Centre, Melbourne, Australia.
Emma LinkDivision of Cancer Research, Peter MacCallum Cancer Centre, Melbourne, Australia.
Tim AkhurstDivision of Medical Imaging, Peter MacCallum Cancer Centre, Melbourne, Australia.
Ben SolomonSir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia.
Michael MichaelSir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia.
Phillip DarcyDivision of Cancer Research, Peter MacCallum Cancer Centre, Melbourne, Australia.
Shienny SampurnoDivision of Cancer Research, Peter MacCallum Cancer Centre, Melbourne, Australia.
Alexander HeriotDivision of Cancer Research, Peter MacCallum Cancer Centre, Melbourne, Australia.
Robert RamsayDivision of Cancer Research, Peter MacCallum Cancer Centre, Melbourne, Australia.
Jayesh DesaiSir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia.
Peter MacCallum Cancer Centre · AUUniversity of Melbourne · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMYB is a transcription factor that is overexpressed in colorectal cancer (CRC) and also a driver mutation in adenoid cystic carcinoma (AdCC). Therefore, the MYB protein is an ideal target to vaccinate against to aid recruitment of tumour infiltrating lymphocytes (TILs) against these tumours. The Peter MacCallum Cancer Centre (Melbourne, Australia) has engineered a DNA vaccine, TetMYB, based on the pVAX1 plasmid vector carrying a fusion construct consisting of the universal tetanus toxin T-cell epitopes flanking an inactivated

methodsThis prospective first-in-human phase I single-arm multi-centre clinical trial involves patients with metastatic CRC or AdCC. Stage 1 will evaluate the safety profile of escalating doses of TetMYB vaccine, given sequentially and in combination with an anti-PD-1 inhibitory antibody, to determine the maximum tolerated dose (MTD). Stage 2 will assess the MTD in an expanded cohort. The calculated sample size is 32 patients: 12 in Stage 1 and 20 in Stage 2. The expected total duration of the trial is 3 years with 15 months of recruitment followed by a minimum of 18 months follow-up. DISCUSSION: MYB transcription factor is aberrantly overexpressed in a range of epithelial cancers, not limited to the above tumour types. Based on promising pre-clinical data of vaccine-induced tumour clearance and establishment of anti-tumour memory, we are embarking on this first-in-human trial. If successful, the results from this trial will allow progression to a Phase II trial and validation of this breakthrough immunotherapeutic approach, not only in CRC and AdCC, but other MYB over-expressing cancers.

trial registrationClinicalTrials.gov ID: NCT03287427. Registered: September 19, 2017.

Indexed as

Adenoid cystic carcinomaCancer vaccineColorectal neoplasmsGlandular and epithelial neoplasmsImmune checkpoint therapyImmunotherapy

Identifiers

PMID31650066
PMCPMC6804811
OpenAlexW2956509864

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.