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Clinical Trials List

Protocol NumberONO-4538-98
NCT Number(ClinicalTrials.gov Identfier)NCT04566380
Active

2020-09-01 - 2026-12-31

Phase II

Not yet recruiting1

Recruiting3

Terminated3

A Multicenter, Open-label, Single-arm, Phase II Pan-Tumor Study in Patients Who Have Participated in Trials to Investigate Efficacy and Safety of ONO-4538 and Are Continuing ONO-4538 Treatment

  • Sponsor

    Ono Pharmaceutical Co., Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 李和昇 Division of Thoracic Medicine

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yuh-Min Chen Division of Thoracic Medicine

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator Li-Tzong Chen Division of General Internal Medicine

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator I-CHEN WU Digestive System Department

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator Kun-Huei Yeh Division of Hematology & Oncology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 林建良 Division of Hematology & Oncology

Co-Principal Investigator

  • 林正耀 Division of Hematology & Oncology

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Ta Yang Division of Thoracic Medicine

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Pan-Tumor

Objectives

Long-term safety of participants receiving ONO-4538 treatment

Test Drug

ONO-4538 (Nivolumab)

Active Ingredient

Nivolumab

Dosage Form

Solution for injection

Dosage

240mg/24mL

Endpoints

Incidence rate of adverse events

Inclution Criteria

Main inclusion criteria:
1) Sex: Male and female
2) Age (at the time of consent): 20 years and older
3) Participant who is eligible for ONO-4538 treatment as per the Parent Study, and/or investigator-assessed clinical benefit
4) Participant who is being treated with ONO-4538 as monotherapy in the Parent Study
5) Women of childbearing potential (WOCBP) must agree to use a double-barrier contraceptive method and avoid breastfeeding during the stipulated period
6) Men must agree to use a contraceptive method during the stipulated period

Exclusion Criteria

Main 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

The Estimated Number of Participants

  • Taiwan

    9 participants

  • Global

    16 participants