Evidence map›Paper›PMID 31980914›Full record

ArticleCancer immunology, immunotherapy : CII2020

First-in-human phase I clinical trial of the NY-ESO-1 protein cancer vaccine with NOD2 and TLR9 stimulants in patients with NY-ESO-1-expressing refractory solid tumors.

Mikiya Ishihara, Yasutaka Tono, Yoshihiro Miyahara, Daisuke Muraoka, Naozumi Harada, Shinichi Kageyama, Takeshi Sasaki, Yasuhide Hori, Norihito Soga, Katsunori Uchida and 9 more

Open access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in Cancer immunology, immunotherapy : CII, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
3.7field-weighted citation impact, top 6% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 1 synthesis or guideline pooled it, 38 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Innovative landscapes in intraperitoneal therapy of ovarian cancer.Drug delivery and translational research · 2025
    Review
  5. Article
  6. Article
  7. NY-ESO-1 antigen: A promising frontier in cancer immunotherapy.Clinical and translational medicine · 2024
    Review
  8. Review
  9. Article
  10. Article
  11. Review
  12. Article
  13. Review
  14. Review
  15. Article
  16. Targeting cancer testis antigens in synovial sarcoma.Journal for immunotherapy of cancer · 2021
    Review
  17. Review
  18. Vascular Stress Signaling in Hypertension.Circulation research · 2021
    Review
  19. Article
  20. 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

19 authors at 5 institutions in 1 country.

Mikiya IshiharaDepartment of Medical Oncology, Mie University Hospital, 2-174 Edobashi, Tsu, Mie, 514-8507, Japan. mishihara@clin.medic.mie-u.ac.jp.ORCID http://orcid.org/0000-0002-7581-2615
Yasutaka TonoDepartment of Medical Oncology, Mie University Hospital, 2-174 Edobashi, Tsu, Mie, 514-8507, Japan.ORCID http://orcid.org/0000-0002-9714-0629
Yoshihiro MiyaharaDepartment of Personalized Cancer Immunotherapy, Mie University Graduate School of Medicine, 1577 Kurimamachiya-cho, Tsu, Mie, 514-8507, Japan.
Daisuke MuraokaDepartment of Oncology, Nagasaki University Graduate School of Biomedical Sciences, 1-12-4 Sakamoto, Nagasaki, Nagasaki, 852-8523, Japan.
Naozumi HaradaUnited Immunity, Co., Ltd., Room220, Mie University Campus Incubator, 1577 Kurimamachiya-cho, Tsu, Mie, 514-8507, Japan.
Shinichi KageyamaDepartment of Immuno-Gene Therapy, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, Mie, 514-8507, Japan.
Takeshi SasakiDepartment of Nephro-Urologic Surgery and Andrology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, Mie, 514-8507, Japan.ORCID http://orcid.org/0000-0002-2458-5686
Yasuhide HoriKameyama Nephro-Urologic Clinic, 1488-215 Sakaemachi, Kameyama, Mie, 519-0111, Japan.ORCID http://orcid.org/0000-0002-0053-995X
Norihito SogaDepartment of Urology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan.
Katsunori UchidaDepartment of Pathology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, Mie, 514-8507, Japan.
Taizo ShiraishiDepartment of Pathology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, Mie, 514-8507, Japan.
Eiichi SatoDepartment of Pathology, Institute of Medical Science (Medical Research Center), Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan.
Hideki KandaDepartment of Nephro-Urologic Surgery and Andrology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, Mie, 514-8507, Japan.
Toshiro MizunoDepartment of Medical Oncology, Mie University Hospital, 2-174 Edobashi, Tsu, Mie, 514-8507, Japan.
Gill A WebsterInnate Immunotherapeutics, Melbourne, VIC, 3051, Australia.
Hiroaki IkedaDepartment of Oncology, Nagasaki University Graduate School of Biomedical Sciences, 1-12-4 Sakamoto, Nagasaki, Nagasaki, 852-8523, Japan.
Naoyuki KatayamaDepartment of Hematology and Oncology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, Mie, 514-8507, Japan.
Yoshiki SugimuraDepartment of Nephro-Urologic Surgery and Andrology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, Mie, 514-8507, Japan.
Hiroshi ShikuDepartment of Personalized Cancer Immunotherapy, Mie University Graduate School of Medicine, 1577 Kurimamachiya-cho, Tsu, Mie, 514-8507, Japan. shiku@clin.medic.mie-u.ac.jp.
Mie University · JPMie University Hospital · JPNagasaki University · JPAichi Cancer Center · JPTokyo Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Cholesteryl pullulan (CHP) is a novel antigen delivery system. CHP and New York esophageal squamous cell carcinoma 1 (NY-ESO-1) antigen complexes (CHP-NY-ESO-1) present multiple epitope peptides to the MHC class I and II pathways. Adjuvants are essential for cancer vaccines. MIS416 is a non-toxic microparticle that activates immunity via the nucleotide-binding oligomerization domain 2 (NOD2) and TLR9 pathways. However, no reports have explored MIS416 as a cancer vaccine adjuvant. We conducted a first-in-human clinical trial of CHP-NY-ESO-1 with MIS416 in patients with NY-ESO-1-expressing refractory solid tumors. CHP-NY-ESO-1/MIS416 (μg/μg) was administered at 100/200, 200/200, 200/400 or 200/600 (cohorts 1, 2, 3 and 4, respectively) every 2 weeks for a total of 6 doses (treatment phase) followed by one vaccination every 4 weeks until disease progression or unacceptable toxicity (maintenance phase). The primary endpoints were safety and tolerability, and the secondary endpoint was the immune response. In total, 26 patients were enrolled. Seven patients (38%) continued vaccination in the maintenance phase. Grade 3 drug-related adverse events (AEs) were observed in six patients (23%): anorexia and hypertension were observed in one and five patients, respectively. No grade 4-5 drug-related AEs were observed. Eight patients (31%) had stable disease (SD). Neither augmentation of the NY-ESO-1-specific IFN-γ-secreting CD8

Indexed as

AdultAgedAged, 80 and overAnimalsAntibodies, NeoplasmAntigens, NeoplasmCancer VaccinesCD8-Positive T-LymphocytesCell Line, TumorFemaleHumansInterferon-gammaMaleMembrane ProteinsMice, Inbred BALB CMiddle AgedAntibodies, NeoplasmAntigens, NeoplasmCancer VaccinesCTAG1B protein, humanInterferon-gammaMembrane ProteinsMIS416 vaccineNOD2 protein, humanNod2 Signaling Adaptor ProteinToll-Like Receptor 9Cancer vaccineNOD2NY-ESO-1 antigenTLR9

Identifiers

PMID31980914
PMCPMC7113205
OpenAlexW3002185671

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.