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ONO-4538

DRUG20 trials

Sponsors

Ono Pharmaceutical Co. Ltd

Conditions

Advanced Non-small Cell Lung CancerAdvanced Non-small Cell Lung Cancer (NSCLC)Advanced Solid TumorsAdvanced or Metastatic Solid TumorsColorectal CancerGastric CancerMalignant Solid TumorMetastatic Pancreatic Cancer

Phase 1

ONO-4538 Phase I Study in Patients With Advanced Malignant Solid Tumors in Japan
CompletedNCT00836888
Ono Pharmaceutical Co. LtdMalignant Solid Tumor
Start: 2009-01-31Updated: 2020-10-08
ONO-4538 Phase I Study in Patients With Solid Tumor
CompletedNCT02261285
Ono Pharmaceutical Co. LtdAdvanced Solid Tumors, Recurrent Solid Tumors
Start: 2014-10-31End: 2014-12-31Updated: 2024-05-06
ONO-4538 Phase I Study in Patients With Solid Tumor
CompletedNCT02261298
Ono Pharmaceutical Co. LtdAdvanced Solid Tumors, Recurrent Solid Tumors
Start: 2014-10-31End: 2020-04-30Updated: 2024-05-03
Study of ONO-4578 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors
Active, not recruitingNCT03155061
Ono Pharmaceutical Co. LtdAdvanced or Metastatic Solid Tumors
Start: 2017-04-19End: 2027-03-31Target: 183Updated: 2025-06-05
A PhaseⅠStudy of ONO-7475 in Combination With ONO-4538 and Gemcitabine Plus Nab-paclitaxel (GnP), the Standard of Care, and ONO-7475 in Combination With GnP in Patients With Pancreatic Cancer
Active, not recruitingNCT06532331
Ono Pharmaceutical Co. LtdMetastatic Pancreatic Cancer
Start: 2023-12-06End: 2028-03-31Target: 87Updated: 2025-04-18
An Open-label, Uncontrolled Study of ONO-7913 and ONO-4538 in Combination With Modified FOLFIRINOX Therapy, the Standard of Care, as First-line Treatment in Patients With Metastatic Pancreatic Cancer
Active, not recruitingNCT06532344
Ono Pharmaceutical Co. LtdMetastatic Pancreatic Cancer
Start: 2021-07-30End: 2026-12-31Updated: 2024-11-14
Study of ONO-7914 Alone and in Combination With ONO-4538 in Patients With Solid Tumors
TerminatedNCT06535009
Ono Pharmaceutical Co. LtdSolid Tumor
Start: 2022-02-08End: 2025-02-26Updated: 2025-06-04
An Open-label, Uncontrolled Study of ONO-4578 and ONO-4538 in Combination With Standard-of-care Modified FOLFIRINOX (mFFX) or Gemcitabine Plus Nab-paclitaxel (GnP) Therapy as First-line Treatment in Patients With Metastatic Pancreatic Cancer
CompletedNCT06538207
Ono Pharmaceutical Co. LtdMetastatic Pancreatic Cancer
Start: 2021-01-13End: 2025-01-30Updated: 2025-02-06
The Study of ONO-7913, ONO-4538 and the Standard of Care as First-line Treatment in Patients Colorectal Cancer
Active, not recruitingNCT06540261
Ono Pharmaceutical Co. LtdUnresectable Colorectal Cancer
Start: 2021-09-23End: 2027-12-31Updated: 2024-09-19
An Open-label, Uncontrolled Study of ONO-4578 and ONO-4538 in Combination With Standard-of-care Docetaxel and Ramucirumab as Second-line Therapy in Patients With Advanced or Recurrent Non-small Cell Lung Cancer
Active, not recruitingNCT06542731
Ono Pharmaceutical Co. LtdNon-small Cell Lung Cancer
Start: 2021-06-01End: 2026-12-31Updated: 2024-08-07
Study of ONO-4578 and XELOX/FOLFOX Plus Bevacizumab in Colorectal Cancer
Active, not recruitingNCT06547385
Ono Pharmaceutical Co. LtdColorectal Cancer
Start: 2021-01-13End: 2027-10-31Updated: 2024-08-09

Phase 2

ONO-4538 Study in Patients With Advanced Non-Small Cell Lung Cancer
CompletedNCT02175017
Ono Pharmaceutical Co. LtdAdvanced Non-small Cell Lung Cancer (NSCLC)
Start: 2014-06-30End: 2021-02-28Updated: 2024-12-09
ONO-4538 Study in Patients With Advanced Non-Small Cell Lung Cancer
CompletedNCT02582125
Ono Pharmaceutical Co. LtdAdvanced Non-small Cell Lung Cancer
Start: 2016-01-27End: 2021-12-31Updated: 2025-03-24
Study of ONO-4538 in Gastric Cancer
CompletedNCT02746796
Ono Pharmaceutical Co. LtdGastric Cancer
Start: 2016-03-31End: 2022-11-17Target: 680Updated: 2024-05-03
ONO-4538 Phase II Rollover Study (ONO-4538-98)
RecruitingNCT04566380
Ono Pharmaceutical Co. LtdPan-tumor
Start: 2020-09-10End: 2026-12-31Target: 59Updated: 2025-06-03
Study to ONO-4538 in Patients With Rhabdoid Tumor
RecruitingNCT06622941
Ono Pharmaceutical Co. LtdRhabdoid Tumor
Start: 2024-11-25End: 2030-03-31Target: 23Updated: 2026-03-12
ONO-4538 Study in Patients With Richter's Transformation
RecruitingNCT06936943
Ono Pharmaceutical Co. LtdRichter's Transformation
Start: 2025-11-19End: 2030-07-31Target: 14Updated: 2026-02-13

Phase 3

Study of ONO-4538 in Unresectable Advanced or Recurrent Gastric Cancer
CompletedNCT02267343
Ono Pharmaceutical Co. LtdGastric Cancer
Start: 2014-10-31End: 2021-01-31Updated: 2024-05-03
Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)
CompletedNCT03117049
Ono Pharmaceutical Co. LtdNon-Small Cell Lung Cancer
Start: 2017-06-13End: 2023-12-04Updated: 2024-05-06
A Study to Evaluate the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)
Active, not recruitingNCT05144854
Ono Pharmaceutical Co. LtdGastric Cancer
Start: 2021-11-05End: 2027-05-31Updated: 2024-09-05

Related Papers

Four‐Year Outcomes for Nivolumab With Chemotherapy and Bevacizumab in Patients With Nonsquamous <scp>NSCLC</scp> in the <scp>TASUKI</scp> ‐52
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<scp>ONO</scp>‐4578 Plus Nivolumab in Unresectable Advanced or Recurrent Gastric or Gastroesophageal Junction Cancer
Cancer Science2025-07-06
Nivolumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Korean Patients with HER2-Negative, Untreated, Unresectable Advanced or Recurrent Gastric or Gastroesophageal Junction Cancer: Subgroup Analysis of a Randomized, Multicenter, Double-Blind Phase 3 Trial (ATTRACTION-4).
2025-07-02
Nivolumab plus chemotherapy in patients with HER2-negative, previously untreated, unresectable, advanced, or recurrent gastric/gastroesophageal junction cancer: 3-year follow-up of the ATTRACTION-4 randomized, double-blind, placebo-controlled, phase 3 trial.
2024-08-2016 citations
First‐in‐human study of <scp>ONO</scp>‐4578, an antagonist of prostaglandin <scp>E<sub>2</sub></scp> receptor 4, alone and with nivolumab in solid tumors
Cancer Science2022-09-0918 citations
Assessment of hyperprogression versus the natural course of disease development with nivolumab with or without ipilimumab versus placebo in phase III, randomized, controlled trials
Journal for ImmunoTherapy of Cancer2022-04-0121 citations
Nivolumab plus chemotherapy versus placebo plus chemotherapy in patients with HER2-negative, untreated, unresectable advanced or recurrent gastric or gastro-oesophageal junction cancer (ATTRACTION-4): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial.
2022-01-11580 citations
KEYNOTE-859: a Phase III Study of Pembrolizumab Plus Chemotherapy in Gastric/Gastroesophageal Junction Adenocarcinoma
Future Oncology2021-05-1255 citations
Abstract 4443: Inhibition of PGE2/EP4 pathway by ONO-4578/BMS-986310, a novel EP4 antagonist, promotes T cell activation and myeloid cell differentiation to dendritic cells
Cancer Research2020-08-154 citations
Nivolumab safety and efficacy in advanced, platinum-resistant, non-small cell lung cancer, radical radiotherapy-ineligible patients: A phase II study in Taiwan
Journal of the Formosan Medical Association2020-02-2212 citations
A phase III study of nivolumab (Nivo) in previously treated advanced gastric or gastric esophageal junction (G/GEJ) cancer (ATTRACTION-2): Three-year update data.
Journal of Clinical Oncology2020-02-0114 citations
Safety and efficacy of nivolumab in combination with S-1/capecitabine plus oxaliplatin in patients with previously untreated, unresectable, advanced, or recurrent gastric/gastroesophageal junction cancer: interim results of a randomized, phase II trial (ATTRACTION-4).
2019-02-01239 citations
Evaluation of efficacy of nivolumab by baseline factors from ATTRACTION-2.
Journal of Clinical Oncology2019-01-293 citations
Phase III, randomised trial of avelumab versus physician's choice of chemotherapy as third-line treatment of patients with advanced gastric or gastro-oesophageal junction cancer: primary analysis of JAVELIN Gastric 300.
2018-10-01377 citations
A phase III study of nivolumab (nivo) in previously treated advanced gastric or gastric esophageal junction (G/GEJ) cancer (ATTRACTION-2): Two-years update data
Annals of Oncology2018-10-0112 citations
Nivolumab safety profile in Asian and Western patients with chemotherapy-refractory (CTx-R) advanced gastric/gastroesophageal junction (adv G/GEJ) cancer from the ATTRACTION-2 and CheckMate-032 trials.
Journal of Clinical Oncology2018-05-203 citations
Nivolumab safety profile in Asian and Western patients with chemotherapy-refractory (CTx-R) advanced gastric/gastroesophageal junction (adv G/GEJ) cancer from the ATTRACTION-2 and CheckMate-032 trials.
Journal of Clinical Oncology2018-02-012 citations
Nivolumab in patients with advanced gastric or gastro-oesophageal junction cancer refractory to, or intolerant of, at least two previous chemotherapy regimens (ONO-4538-12, ATTRACTION-2): a randomised, double-blind, placebo-controlled, phase 3 trial.
2017-10-061741 citations
Phase II study of nivolumab in patients with advanced non-small cell lung cancer (NSCLC) in Korea.
Journal of Clinical Oncology2017-03-01
Nivolumab (ONO-4538/BMS-936558) as salvage treatment after second or later-line chemotherapy for advanced gastric or gastro-esophageal junction cancer (AGC): A double-blinded, randomized, phase III trial.
Journal of Clinical Oncology2017-02-01105 citations