Pan-tumorPhase 2NCT04566380
ONO-4538 Phase II Rollover Study (ONO-4538-98)
A Phase 2 study testing ONO-4538, oxaliplatin and S-1 in people with Pan-tumor, run by Ono Pharmaceutical Co., Ltd. at 44 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pan-tumor
- What is being tested?
- ONO-4538, oxaliplatin and S-1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 44 sitesin 3 countries
- Study dates
- 10 Sep 2020to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
44 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
North America Clinical Trial Support Desk contact
International Clinical Trial Support Desk contact
44 sites in 3 countries
Japan23 sites, 13 recruiting
- Completed
Hyogo Clinical Site1
Akashi, Hyōgo
- Recruiting
Tokyo Clinical Site3
Bunkyo-ku, Tokyo
- Completed
Chiba Clinical Site2
Chiba, Chiba
- Recruiting
Tokyo Clinical Site2
Chuo-ku, Tokyo
- Completed
Fukuoka Clinical Site2
Fukuoka, Fukuoka
- Completed
Fukuoka Clinical Site3
Fukuoka, Fukuoka
- Recruiting
Saitama Clinical Site1
Hidaka, Saitama
- Recruiting
Hiroshima Clinical Site1
Hiroshima, Hiroshima
- Completed
Chiba Clinical Site1
Kashiwa, Chiba
- Completed
Saitama Clinical Site2
Kitaadachi-gun, Saitama
- Completed
Tokyo Clinical Site1
Koto-ku, Tokyo
- Recruiting
Tokyo Clinical Site5
Koto-Ku, Tokyo
- Completed
Fukuoka Clinical Site1
Kurume, Fukuoka
- Recruiting
Kyoto Clinical Site1
Kyoto, Kyoto
- Completed
Ehime Clinical Site1
Matsuyama, Ehime
- Recruiting
Okayama Clinical Site1
Okayama, Okayama-ken
- Recruiting
Osaka Clinical Site2
Osaka, Osaka
- Recruiting
Hokkaido Clinical Site1
Sapporo, Hokkaido
- Recruiting
Tokyo Clinical Site4
Shinjuku-ku, Tokyo
- Recruiting
Osaka Clinical Site1
Suita, Osaka
- Recruiting
Osaka Clinical Site3
Takatsuki, Osaka
- Completed
Kanagawa Clinical Site1
Yokohama, Kanagawa
- Recruiting
Oita Clinical Site1
Yufu, Oita Prefecture
South Korea13 sites, 11 recruiting
- Recruiting
Daegu Clinical Site1
Daegu, South Korea
- Recruiting
Daegu Clinical Site2
Daegu
- Recruiting
Daegu Clinical Site3
Daegu
- Recruiting
Gyeonggi-do Clinical site1
Gyeonggi-do
- Recruiting
Hwasun Clinical Site1
Hwasun
- Completed
Incheon Clinical Site1
Incheon
- Recruiting
Seoul Clinical Site1
Seoul
- Completed
Seoul Clinical Site2
Seoul
- Recruiting
Seoul Clinical Site3
Seoul
- Recruiting
Seoul Clinical Site4
Seoul
- Recruiting
Seoul Clinical Site5
Seoul
- Recruiting
Seoul Clinical Site6
Seoul
- Recruiting
Suwon Clinical Site1
Suwon
Taiwan8 sites, 6 recruiting
- Completed
Kaohsiung Clinical Site1
Kaohsiung City
- Completed
Kaohsiung Clinical Site2
Kaohsiung City
- Recruiting
New Taipei City Clinical Site1
New Taipei City
- Recruiting
Tainan Clinical Site1
Tainan
- Recruiting
Tainan Clinical Site2
Tainan
- Recruiting
Taipei Clinical Site1
Taipei
- Recruiting
Taipei Clinical Site2
Taipei
- Recruiting
Taoyuan Clinical Site1
Taoyuan, Taiwan
About this study
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)
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
- Being tested
- ONO-4538, oxaliplatin, S-1, capecitabine, bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-4538Drug
IV infusion over 30 minutes
oxaliplatinDrug
IV infusion over 2 hours
S-1Drug
Administered orally twice daily
capecitabineDrug
Administered orally twice daily
bevacizumabDrug
IV infusion over 30 minutes
temozolomideDrug
Administered orally once daily for 5 days every 28 days
IpilimumabDrug
IV infusion over 30 minutes
ONO-7703Drug
Administered orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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, Temozolomide, Ipilimumab + SOX therapy, Ipilimumab + CapeOX therapy or ONO-7703) selected by the principal investigator or subinvestigator in the Parent Study will be continued in this study. Receives: Drug: ONO-4538; Drug: oxaliplatin; Drug: S-1; Drug: capecitabine; Drug: bevacizumab; Drug: temozolomide; Drug: Ipilimumab; Drug: ONO-7703 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (Aes)
(non)
Measured: From Day 1 up to 28 days after the end of the treatment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start10 Sep 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pan-tumorStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Project Leader, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566380
- Sponsor's protocol ID
- ONO-4538-98
- Other IDs
- jRCT2080225345
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2020
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04566380
- Acronym / sponsor ID
- ONO-4538-98
- Conditions
- Pan-tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONO-4538 Monotherapy cohort | Experimental | Drug: ONO-4538480 mg of ONO-4538 IV Q4W or 240 mg of ONO-4538 IV Q2W per the investigator's choice |
| Combination therapy cohort | Experimental | Drug: ONO-4538, Drug: oxaliplatin, Drug: S-1, Drug: capecitabine, Drug: bevacizumab, Drug: temozolomide, Drug: Ipilimumab, Drug: ONO-7703ONO-4538 at 360 mg IV Q3W or 480 mg IV Q4W, and Combination therapies (S-1 + Oxaliplatin [SOX] therapy , Capecitabine + Oxaliplatin [CapeOX] therapy , Bevacizumab, Temozolomide, Ipilimumab + SOX therapy, Ipilimumab + CapeOX therapy or ONO-7703) selected by the principal investigator or subinvestigator in the Parent Study will be continued in this study. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONO-4538IV infusion over 30 minutes | Drug | Combination therapy cohort, ONO-4538 Monotherapy cohort |
| oxaliplatinIV infusion over 2 hours | Drug | Combination therapy cohort |
| S-1Administered orally twice daily | Drug | Combination therapy cohort |
| capecitabineAdministered orally twice daily | Drug | Combination therapy cohort |
| bevacizumabIV infusion over 30 minutes | Drug | Combination therapy cohort |
| temozolomideAdministered orally once daily for 5 days every 28 days | Drug | Combination therapy cohort |
| IpilimumabIV infusion over 30 minutes | Drug | Combination therapy cohort |
| ONO-7703Administered orally twice daily | Drug | Combination therapy cohort |
Primary outcome
Incidence of Adverse Events (Aes)
Time frame: From Day 1 up to 28 days after the end of the treatment phase
(non)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
North America Clinical Trial Support Desk contact
International Clinical Trial Support Desk contact
Project Leader study director
Ono Pharmaceutical Co., Ltd.
44 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ONO-4538, oxaliplatin and S-1 in people with Pan-tumor, run by Ono Pharmaceutical Co., Ltd. at 44 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in Japan, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact North America Clinical Trial Support Desk (+18665877745(Toll-Free), clinical_trial@ono-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (Aes) (time frame: From Day 1 up to 28 days after the end of the treatment phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.