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

• Sponsor: Ono Pharmaceutical Co. Ltd (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04566380
• Collaborator: (none)
• Enrollment: 33
• Locations: 22
• Arms: 2
• Anticipated Duration (Months): 60.6
• Patients Per Site: 1.5
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pan-tumor	Drug: ONO-4538; Drug: oxaliplatin; Drug: S-1; Drug: capecitabine	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 33 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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)
• Actual Study Start Date: Sep 10, 2020
• Anticipated Primary Completion Date: Sep 30, 2025
• Anticipated Study Completion Date: Sep 30, 2025

Arms and Interventions

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, and Chemotherapies (S-1 + Oxaliplatin [SOX] therapy or Capecitabine + Oxaliplatin [CapeOX] therapy) 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

Outcome Measures

Primary Outcome Measures

1. Incidence of Adverse Events (Aes) [From Day 1 up to 28 days after the end of the treatment phase]

   (non)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ehime Clinical Site1	Matsuyama	Ehime	Japan
2	Fukuoka Clinical Site1	Kurume	Fukuoka	Japan
3	Saitama Clinical Site1	Hidaka	Saitama	Japan
4	Tokyo Clinical Site3	Bunkyo-ku	Tokyo	Japan
5	Tokyo Clinical Site2	Chuo-ku	Tokyo	Japan
6	Tokyo Clinical Site1	Koto-ku	Tokyo	Japan
7	Kyoto Clinical Site1	Kyoto		Japan
8	Okayama Clinical Site1	Okayama		Japan
9	Gyeonggi-do Clinical site1	Gyeonggi-do		Korea, Republic of
10	Incheon Clinical Site1	Incheon		Korea, Republic of
11	Seoul Clinical Site1	Seoul		Korea, Republic of
12	Seoul Clinical Site2	Seoul		Korea, Republic of
13	Seoul Clinical Site3	Seoul		Korea, Republic of
14	Seoul Clinical Site4	Seoul		Korea, Republic of
15	Seoul Clinical Site5	Seoul		Korea, Republic of
16	Seoul Clinical Site6	Seoul		Korea, Republic of
17	Kaohsiung Clinical Site1	Kaohsiung		Taiwan
18	Kaohsiung Clinical Site2	Kaohsiung		Taiwan
19	Tainan Clinical Site1	Tainan		Taiwan
20	Tainan Clinical Site2	Tainan		Taiwan
21	Taipei Clinical Site1	Taipei		Taiwan
22	Taipei Clinical Site2	Taipei		Taiwan

Sponsors and Collaborators

• Ono Pharmaceutical Co. Ltd

Investigators

• Study Director: Yuma Tano, Ono Pharmaceutical Co. Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ono Pharmaceutical Co. Ltd
• ClinicalTrials.gov Identifier: NCT04566380
• Other Study ID Numbers: ONO-4538-98
• First Posted: Sep 28, 2020
• Last Update Posted: Mar 14, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Capecitabine; Oxaliplatin; Nivolumab

Study Results

No Results Posted as of Mar 14, 2022