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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04566380
Recruitment Status : Recruiting
First Posted : September 28, 2020
Last Update Posted : September 8, 2021
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

Study Description
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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 in clinical trials.

Condition or disease Intervention/treatment Phase
Pan-tumor Drug: ONO-4538 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 (ONO-4538-98)
Actual Study Start Date : September 10, 2020
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : September 30, 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: ONO-4538 group
Specified Dosage and Duration of Treatment
 Drug: ONO-4538
IV infusion over 30 minutes


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Adverse Events (Aes) [ Time Frame: From Day 1 up to 28 days after the end of the treatment phase ]
    (non)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participant who is being treated with ONO-4538 as monotherapy in clinical trials
  2. Participant who is eligible for ONO-4538 treatment 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04566380


Contacts
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Contact: Ono Pharmaceutical Co. Ltd Medical Information Center clinical_trial@ono.co.jp

Locations
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Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Yuma Tano Ono Pharmaceutical Co. Ltd
More Information
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Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT04566380    
Other Study ID Numbers: ONO-4538-98
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
URL: https://www.ono.co.jp/eng/rd/policy.html

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action