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

NCT04566380 | Recruiting Phase 2

• 2 other identifiers: ONO-4538-98jRCT2080225345
• Study Type: interventional
• Target: 59
• Locations: 3 countries
• Sites: 38

Brief Summary

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.

Conditions

Pan-tumor

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events (Aes)

  (non)

  From Day 1 up to 28 days after the end of the treatment phase

Study Arms (2)

ONO-4538 Monotherapy cohort

EXPERIMENTAL

480 mg of ONO-4538 IV Q4W or 240 mg of ONO-4538 IV Q2W per the investigator's choice

Drug: ONO-4538

Combination therapy cohort

EXPERIMENTAL

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; Drug: oxaliplatin; Drug: S-1; Drug: capecitabine; Drug: bevacizumab; Drug: temozolomide

Interventions

ONO-4538 DRUG

IV infusion over 30 minutes

Combination therapy cohort; ONO-4538 Monotherapy cohort

oxaliplatin DRUG

IV infusion over 2 hours

Combination therapy cohort

S-1 DRUG

Administered orally twice daily

Combination therapy cohort

capecitabine DRUG

Administered orally twice daily

Combination therapy cohort

bevacizumab DRUG

IV infusion over 30 minutes

Combination therapy cohort

temozolomide DRUG

Administered orally once daily for 5 days every 28 days

Combination therapy cohort

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant who is being treated with ONO-4538 as monotherapy or in Combination with Other Therapies in clinical trials
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ono Pharmaceutical Co. Ltd: lead

Study Sites (38)

Chiba Clinical Site1

Kashiwa, Chiba, Japan

RECRUITING

Ehime Clinical Site1

Matsuyama, Ehime, Japan

COMPLETED

Fukuoka Clinical Site1

Kurume, Fukuoka, Japan

RECRUITING

Hokkaido Clinical Site1

Sapporo, Hokkaido, Japan

RECRUITING

Hyogo Clinical Site1

Akashi, Hyōgo, Japan

RECRUITING

Kanagawa Clinical Site1

Yokohama, Kanagawa, Japan

RECRUITING

Oita Clinical Site1

Yufu, Oita Prefecture, Japan

RECRUITING

Osaka Clinical Site1

Suita, Osaka, Japan

RECRUITING

Osaka Clinical Site3

Takatsuki, Osaka, Japan

RECRUITING

Saitama Clinical Site1

Hidaka, Saitama, Japan

RECRUITING

Saitama Clinical Site2

Kitaadachi-gun, Saitama, Japan

RECRUITING

Tokyo Clinical Site3

Bunkyo-ku, Tokyo, Japan

RECRUITING

Tokyo Clinical Site2

Chuo-ku, Tokyo, Japan

RECRUITING

Tokyo Clinical Site1

Koto-ku, Tokyo, Japan

RECRUITING

Tokyo Clinical Site4

Shinjuku-ku, Tokyo, Japan

RECRUITING

Chiba Clinical Site2

Chiba, Japan

RECRUITING

Fukuoka Clinical Site2

Fukuoka, Japan

RECRUITING

Fukuoka Clinical Site3

Fukuoka, Japan

RECRUITING

Hiroshima Clinical Site1

Hiroshima, Japan

RECRUITING

Kyoto Clinical Site1

Kyoto, Japan

RECRUITING

Okayama Clinical Site1

Okayama, Japan

RECRUITING

Osaka Clinical Site2

Osaka, Japan

RECRUITING

Daegu Clinical Site1

Daegu, South Korea

RECRUITING

Gyeonggi-do Clinical site1

Gyeonggi-do, South Korea

RECRUITING

Incheon Clinical Site1

Incheon, South Korea

RECRUITING

Seoul Clinical Site1

Seoul, South Korea

RECRUITING

Seoul Clinical Site2

Seoul, South Korea

COMPLETED

Seoul Clinical Site3

Seoul, South Korea

RECRUITING

Seoul Clinical Site4

Seoul, South Korea

RECRUITING

Seoul Clinical Site5

Seoul, South Korea

RECRUITING

Seoul Clinical Site6

Seoul, South Korea

RECRUITING

Kaohsiung Clinical Site1

Kaohsiung City, Taiwan

COMPLETED

Kaohsiung Clinical Site2

Kaohsiung City, Taiwan

COMPLETED

Tainan Clinical Site1

Tainan, Taiwan

RECRUITING

Tainan Clinical Site2

Tainan, Taiwan

RECRUITING

Taipei Clinical Site1

Taipei, Taiwan

RECRUITING

Taipei Clinical Site2

Taipei, Taiwan

RECRUITING

Taoyuan Clinical Site1

Taoyuan District, Taiwan

RECRUITING

MeSH Terms

Interventions

Nivolumab; Oxaliplatin; S 1 (combination); Capecitabine; Bevacizumab; Temozolomide

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dacarbazine; Triazenes; Imidazoles; Azoles

Study Officials

• Project Leader

  Ono Pharmaceutical Co. Ltd

  STUDY DIRECTOR

Central Study Contacts

North America Clinical Trial Support Desk

CONTACT

+18665877745(Toll-Free); clinical_trial@ono-pharma.com

International Clinical Trial Support Desk

CONTACT

+17162141777(Standard); clinical_trial@ono-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 28, 2020
• Study Start: September 10, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (9); TW (7); JP (22)