ONO-4538 Phase II Rollover Study (ONO-4538-98)

A Multicenter, Open-label, Phase II Pan-Tumor Study in Patients Who Have Participated in Trials to Investigate Efficacy and Safety of ONO-4538 as Monotherapy or in Combination With Other Therapies and Are Continuing ONO-4538 Treatment (ONO-4538-98)

This study is intended to confirm the long-term safety of ONO-4538 in pan-tumor participants being treated with ONO-4538 monotherapy or in Combination with Other Therapies in clinical trials.

Study Overview

• Status: Recruiting
• Conditions: Pan-tumor
• Intervention / Treatment: Drug: ONO-4538; Drug: oxaliplatin; Drug: S-1; Drug: capecitabine; Drug: bevacizumab; Drug: temozolomide

• Study Type: Interventional
• Enrollment (Estimated): 59
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: North America Clinical Trial Support Desk; Phone Number: +18665877745(Toll-Free); Email: clinical_trial@ono-pharma.com
• Study Contact Backup: Name: International Clinical Trial Support Desk; Phone Number: +17162141777(Standard); Email: clinical_trial@ono-pharma.com

Study Locations

• Japan
  • Chiba, Japan
    • Recruiting
    • Chiba Clinical Site2
  • Fukuoka, Japan
    • Recruiting
    • Fukuoka Clinical Site2
  • Fukuoka, Japan
    • Recruiting
    • Fukuoka Clinical Site3
  • Hiroshima, Japan
    • Recruiting
    • Hiroshima Clinical Site1
  • Kyoto, Japan
    • Recruiting
    • Kyoto Clinical Site1
  • Okayama, Japan
    • Recruiting
    • Okayama Clinical Site1
  • Osaka, Japan
    • Recruiting
    • Osaka Clinical Site2
  • Chiba
    • Kashiwa, Chiba, Japan
      • Recruiting
      • Chiba Clinical Site1
  • Ehime
    • Matsuyama, Ehime, Japan
      • Completed
      • Ehime Clinical Site1
  • Fukuoka
    • Kurume, Fukuoka, Japan
      • Recruiting
      • Fukuoka Clinical Site1
  • Hokkaido
    • Sapporo, Hokkaido, Japan
      • Recruiting
      • Hokkaido Clinical Site1
  • Hyogo
    • Akashi, Hyogo, Japan
      • Recruiting
      • Hyogo Clinical Site1
  • Kanagawa
    • Yokohama, Kanagawa, Japan
      • Recruiting
      • Kanagawa Clinical Site1
  • Oita
    • Yufu, Oita, Japan
      • Recruiting
      • Oita Clinical Site1
  • Osaka
    • Suita, Osaka, Japan
      • Recruiting
      • Osaka Clinical Site1
    • Takatsuki, Osaka, Japan
      • Recruiting
      • Osaka Clinical Site3
  • Saitama
    • Hidaka, Saitama, Japan
      • Recruiting
      • Saitama Clinical Site1
    • Kitaadachi-gun, Saitama, Japan
      • Recruiting
      • Saitama Clinical Site2
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan
      • Recruiting
      • Tokyo Clinical Site3
    • Chuo-ku, Tokyo, Japan
      • Recruiting
      • Tokyo Clinical Site2
    • Koto-ku, Tokyo, Japan
      • Recruiting
      • Tokyo Clinical Site1
    • Shinjuku-ku, Tokyo, Japan
      • Recruiting
      • Tokyo Clinical Site4
• Korea, Republic of
  • Daegu, Korea, Republic of
    • Recruiting
    • Daegu Clinical Site1
  • Gyeonggi-do, Korea, Republic of
    • Recruiting
    • Gyeonggi-do Clinical site1
  • Incheon, Korea, Republic of
    • Recruiting
    • Incheon Clinical Site1
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul Clinical Site1
  • Seoul, Korea, Republic of
    • Completed
    • Seoul Clinical Site2
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul Clinical Site3
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul Clinical Site4
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul Clinical Site5
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul Clinical Site6
• Taiwan
  • Kaohsiung, Taiwan
    • Completed
    • Kaohsiung Clinical Site1
  • Kaohsiung, Taiwan
    • Completed
    • Kaohsiung Clinical Site2
  • Tainan, Taiwan
    • Recruiting
    • Tainan Clinical Site1
  • Tainan, Taiwan
    • Recruiting
    • Tainan Clinical Site2
  • Taipei, Taiwan
    • Recruiting
    • Taipei Clinical Site1
  • Taipei, Taiwan
    • Recruiting
    • Taipei Clinical Site2
  • Taoyuan, Taiwan
    • Recruiting
    • Taoyuan Clinical Site1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participant who is being treated with ONO-4538 as monotherapy or in Combination with Other Therapies in clinical trials
2. Participant who is eligible for ONO-4538 monotherapy or in combination with other therapies as per the clinical trials, and/or investigator-assessed clinical benefit

Exclusion Criteria:

1. Participant judged to be incapable of providing consent for reasons such as concurrent dementia
2. Participant judged by the investigator to be inappropriate as participants of this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ONO-4538 Monotherapy cohort; 480 mg of ONO-4538 IV Q4W or 240 mg of ONO-4538 IV Q2W per the investigator's choice	Drug: ONO-4538; IV infusion over 30 minutes
Experimental: Combination therapy cohort; ONO-4538 at 360 mg IV Q3W or 480 mg IV Q4W, and Combination therapies (S-1 + Oxaliplatin [SOX] therapy , Capecitabine + Oxaliplatin [CapeOX] therapy , Bevacizumab or Temozolomide) selected by the principal investigator or subinvestigator in the Parent Study will be continued in this study.	Drug: ONO-4538; IV infusion over 30 minutes; Drug: oxaliplatin; IV infusion over 2 hours; Drug: S-1; Administered orally twice daily; Drug: capecitabine; Administered orally twice daily; Drug: bevacizumab; IV infusion over 30 minutes; Drug: temozolomide; Administered orally once daily for 5 days every 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events (Aes)	(non)	From Day 1 up to 28 days after the end of the treatment phase

Collaborators and Investigators

• Sponsor: Ono Pharmaceutical Co. Ltd
• Investigators: Study Director: Project Leader, Ono Pharmaceutical Co. Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: June 1, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents, Alkylating; Alkylating Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Temozolomide; Capecitabine; Oxaliplatin; Nivolumab; Bevacizumab
• Other Study ID Numbers: ONO-4538-98; jRCT2080225345 (Registry Identifier: Japan Registry of Clinical Trials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No