Evidence map›Paper›PMID 40618725›Full record

ArticleCancer science2025

ONO-4578 Plus Nivolumab in Unresectable Advanced or Recurrent Gastric or Gastroesophageal Junction Cancer.

Akihito Kawazoe, Kensei Yamaguchi, Tetsuya Hamaguchi, Yukiya Narita, Shogen Boku, Takashi Oshima, Hiroki Hara, Yasuo Hamamoto, Kenji Ishido, Taito Esaki and 15 more

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

Article in Cancer science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03155061 (Phase 1 Dose Escalating and Expansion Study of ONO-4578 Given as Monotherapy and Combinations of ONO-4578 and ONO-4538 in Subjects With Advanced or Metastatic Solid Tumors), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT03155061 phase1active not recruitingnot on this map

Phase 1 Dose Escalating and Expansion Study of ONO-4578 Given as Monotherapy and Combinations of ONO-4578 and ONO-4538 in Subjects With Advanced or Metastatic Solid Tumors

TypeinterventionalSponsorOno Pharmaceutical Co., Ltd.Ran2017 to 2027Enrolled183ConditionsAdvanced or Metastatic Solid TumorsArmsONO-4578, ONO-4538
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

25 authors.

Akihito KawazoeDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.ORCID https://orcid.org/0000-0001-8632-3748
Kensei YamaguchiDepartment Director of Gastroenterological Chemotherapy, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Tetsuya HamaguchiDepartment of Gastroenterological Oncology, Saitama Medical University International Medical Center, Saitama, Japan.
Yukiya NaritaDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Shogen BokuCancer Treatment Center, Kansai Medical University Hospital, Hirakata, Japan.ORCID https://orcid.org/0000-0002-5015-0379
Takashi OshimaDepartment of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan.
Hiroki HaraDepartment of Gastroenterology, Saitama Cancer Center, Kitaadachi-gun, Japan.
Yasuo HamamotoKeio Cancer Center, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan.ORCID https://orcid.org/0000-0002-5737-122X
Kenji IshidoDepartment of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Japan.
Taito EsakiDepartment of Gastrointestinal and Medical Oncology, NHO Kyushu Cancer Center, Fukuoka, Japan.ORCID https://orcid.org/0000-0002-9169-8453
Hisashi HosakaDepartment of Gastroenterology, Gunma Prefectural Cancer Center, Ota-shi, Gunma, Japan.
Hirofumi YasuiDivision of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
Keisuke KoedaDepartment of Medical Safety Science, Iwate Medical University School of Medicine, Shiwa, Japan.
Tomohiro NishinaDepartment of Gastrointestinal Medical Oncology, NHO Shikoku Cancer Center, Matsuyama, Japan.
Yasushi TsujiDepartment of Medical Oncology, Tonan Hospital, Sapporo, Japan.
Takeo FukagawaDepartment of Surgery, School of Medicine Teikyo University, Tokyo, Japan.
Masahiro GotoCancer Chemotherapy Center, Osaka Medical and Pharmaceutical University Hospital, Takatsuki, Japan.
Eiji OkiDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.ORCID https://orcid.org/0000-0002-9763-9366
Naotoshi SugimotoDepartment of Genetic Oncology, Osaka International Cancer Institute, Osaka, Japan.
Hiroshi MatsuokaDepartment of Surgery, Fujita Health University, Toyoake, Aichi, Japan.
Fumiharu YokoyamaTranslational Research Group, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
Tomoko YoshidaBioinformatics Group, Drug Discovery Tech, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
Kazuo YoshidaStatistical Analysis Section, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
Yoshiaki OshimaOncology Early Clinical Development Planning, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
Satoru IwasaDepartment of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.

Funding

Ono Pharmaceutical
6 · The paper itself

Abstract

ONO-4578, an EP4 antagonist, alone and combined with nivolumab, showed acceptable safety profiles and signs of antitumor activity in solid tumors. The expansion part examined the safety, preliminary efficacy, and biomarkers of ONO-4578 plus nivolumab in unresectable advanced or recurrent gastric or gastroesophageal junction (G/GEJ) cancer. Patients were enrolled into three groups: with previous immuno-oncology treatment (IO-treated; n = 30), without IO treatment (IO-naive; n = 30), and with UGT1A1 polymorphism (UGT1A1p; n = 6). Treatment-related adverse events (TRAEs) occurred in 46 patients (grade 3-4 in 17), with no grade 5 events reported. We confirmed the tolerability of the treatment in UGT1A1p. Objective response and disease control rates were 10.0% and 73.3%, respectively, in IO-treated and 16.7% and 40.0%, respectively, in IO-naive. Biomarker analysis indicated immune activation in the tumor microenvironment after the treatment. In conclusion, ONO-4578 plus nivolumab showed a manageable safety profile and antitumor activity in G/GEJ cancer. Trial Registration: Japan Registry of Clinical Trials number: jRCT2080223441; ClinicalTrials.gov identifier: NCT03155061.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsEsophageal NeoplasmsEsophagogastric JunctionNeoplasm Recurrence, LocalNivolumabStomach NeoplasmsAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedTumor MicroenvironmentNivolumabdose‐limiting toxicitygastric cancernivolumabphase Iprostaglandin E2 receptor EP4

Identifiers

PMID40618725
PMCPMC12400061

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.