Solid TumorPhase 1NCT02476123
Study of Combination Therapy With Mogamulizumab (KW-0761) and Nivolumab (ONO-4538/BMS-936558) in Subjects With Advanced Solid Tumors
A Phase 1 study testing Mogamulizumab: KW-0761, Nivolumab: (ONO-4538/BMS-936558) in people with Solid Tumor, run by Kyowa Kirin Co., Ltd. at 2 sites in Japan.
Trial summary
The purpose of this study is to characterize the safety and tolerability and determine the maximum tolerated dose (MTD) or the recommended fixed dose of the combinations of Mogamulizumab and Nivolumab in subjects with locally advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Mogamulizumab: KW-0761, Nivolumab: (ONO-4538/BMS-936558)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 2 sitesJapan
- Study dates
- Jun 2015to 21 Dec 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who voluntarily signed and dated Institutional Review Board approved informed consent form in accordance with regulatory and institutional guidelines.
- Subjects who have progressed or have been intolerant to any standard treatment regimen or refused standard treatment, or for which adequate standard therapy does not exist.
- Subjects who have evaluable lesion per guideline of Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Subjects with life expectancy > 12 weeks.
- Subjects with Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
- Potential child-bearing female who has agreed with contraception and not breast-feeding. For male who also has agreed with contraception.
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- Subjects who have adequate hematological, renal, hepatic and respiratory functions defined.
- Must agree to present archival tumor tissues to sponsor or be willing to undergo a pre-treatment biopsy.
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors.
Who cannot join
- Female subjects who are pregnant or breast-feeding.
- Subjects with uncontrolled and significant inter-current illness.
- Subjects with known central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Subjects who have been previously treated with an anti-programmed death 1 (PD-1), anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- Subjects who have been previously treated with Mogamulizumab.
- Subjects with any prior Grade ≥ 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE.
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- Subjects with a history of severe hypersensitivity reactions to drugs.
- Subjects who have been received chemotherapies, immunotherapy, biologic or hormonal therapies, another investigational drug, radiation or major surgery for cancer treatment within 28 days or 42 days (for nitrosourea or mitomycin C) prior to Cycle 1 Day 1.
- Subjects who have known active autoimmune disease or syndrome.
- Subjects who have active inflammatory bowel disease, irritable bowel disease, celiac disease, or other serious GI chronic conditions associated with diarrhea.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Phase 1 Study of Combination Therapy With Mogamulizumab (KW-0761) and Nivolumab (ONO-4538/BMS-936558) in Subjects With Advanced Solid Tumors
The purpose of this study is to characterize the safety and tolerability and determine the maximum tolerated dose (MTD) or the recommended fixed dose of the combinations of Mogamulizumab and Nivolumab in subjects with locally advanced or metastatic solid tumors.
- Conditions
- Solid Tumor
- Being tested
- Mogamulizumab: KW-0761, Nivolumab: (ONO-4538/BMS-936558)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mogamulizumab: KW-0761, Nivolumab: (ONO-4538/BMS-936558)Biological
i.v. administration
| Study group | Role | What they receive |
|---|---|---|
| Mogamulizumab+Nivolumab | Experimental | During parts 1 and 2, Mogamulizumab and Nivolumab are administered at appropriate intervals.
Part 1 (Dose Escalation Part) During Cohort 1 to 2, Mogamulizumab and Nivolumab are administered in combination.
Part 2 (Expansion Part) Patients will be treated with maximum tolerated dose established in the dose escalation part for each combination. Receives: Biological: Mogamulizumab: KW-0761, Nivolumab: (ONO-4538/BMS-936558) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects reporting adverse events
Measured: From the first dose of study medications until 90 days after the last dose of study medication
Number of subjects reporting serious adverse events
Measured: From the first dose of study medications until 90 days after the last dose of study medication
Percentage of subjects reporting serious adverse events
Measured: From the first dose of study medications until 90 days after the last dose of study medication
Percentage of subjects reporting adverse events
Measured: From the first dose of study medications until 90 days after the last dose of study medication
Number of subjects experiencing dose-limiting toxicity
Measured: For 28 days from the first dose of study medications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startJun 2015
- Primary completion7 Feb 2018
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476123
- Sponsor's protocol ID
- 0761-013
- Status last verified
- Jun 2019
- First submitted
- 10 Jun 2015
- Last updated
- 11 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Doi T, Muro K, Ishii H, Kato T, Tsushima T, Takenoyama M, Oizumi S, Gemmoto K, Suna H, Enokitani K, Kawakami T, Nishikawa H, Yamamoto N. A Phase I Study of the Anti-CC Chemokine Receptor 4 Antibody, Mogamulizumab, in Combination with Nivolumab in Patients with Advanced or Metastatic Solid Tumors. Clin Cancer Res. 2019 Nov 15;25(22):6614-6622. doi: 10.1158/1078-0432.CCR-19-1090. Epub 2019 Aug 27.
PubMed 31455681
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Combination Therapy With Mogamulizumab (KW-0761) and Nivolumab (ONO-4538/BMS-936558) in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02476123
- Acronym / sponsor ID
- 0761-013
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Study start
- Jun 2015
- Primary completion
- 7 Feb 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 19 Jun 2015 (estimated)
- 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.
The purpose of this study is to characterize the safety and tolerability and determine the maximum tolerated dose (MTD) or the recommended fixed dose of the combinations of Mogamulizumab and Nivolumab in subjects with locally advanced or metastatic solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mogamulizumab+Nivolumab | Experimental | Biological: Mogamulizumab: KW-0761, Nivolumab: (ONO-4538/BMS-936558)During parts 1 and 2, Mogamulizumab and Nivolumab are administered at appropriate intervals. Part 1 (Dose Escalation Part) During Cohort 1 to 2, Mogamulizumab and Nivolumab are administered in combination. Part 2 (Expansion Part) Patients will be treated with maximum tolerated dose established in the dose escalation part for each combination. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects who voluntarily signed and dated Institutional Review Board approved informed consent form in accordance with regulatory and institutional guidelines.
- Subjects who have progressed or have been intolerant to any standard treatment regimen or refused standard treatment, or for which adequate standard therapy does not exist.
- Subjects who have evaluable lesion per guideline of Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Subjects with life expectancy > 12 weeks.
- Subjects with Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
Key exclusion criteria (10 listed)
- Female subjects who are pregnant or breast-feeding.
- Subjects with uncontrolled and significant inter-current illness.
- Subjects with known central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Subjects who have been previously treated with an anti-programmed death 1 (PD-1), anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- Subjects who have been previously treated with Mogamulizumab.
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 |
|---|---|---|
| Mogamulizumab: KW-0761, Nivolumab: (ONO-4538/BMS-936558)i.v. administration | Biological | Mogamulizumab+Nivolumab |
Primary outcome
Number of subjects reporting adverse events
Time frame: From the first dose of study medications until 90 days after the last dose of study medication
Number of subjects reporting serious adverse events
Time frame: From the first dose of study medications until 90 days after the last dose of study medication
Percentage of subjects reporting serious adverse events
Time frame: From the first dose of study medications until 90 days after the last dose of study medication
Percentage of subjects reporting adverse events
Time frame: From the first dose of study medications until 90 days after the last dose of study medication
Number of subjects experiencing dose-limiting toxicity
Time frame: For 28 days from the first dose of study medications
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Derived from this study: PubMed 31455681Doi T, Muro K, Ishii H, Kato T, Tsushima T, Takenoyama M, Oizumi S, Gemmoto K, Suna H, Enokitani K, Kawakami T, Nishikawa H, Yamamoto N. A Phase I Study of the Anti-CC Chemokine Receptor 4 Antibody, Mogamulizumab, in Combination with Nivolumab in Patients with Advanced or Metastatic Solid Tumors. Clin Cancer Res. 2019 Nov 15;25(22):6614-6622. doi: 10.1158/1078-0432.CCR-19-1090. Epub 2019 Aug 27.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mogamulizumab: KW-0761, Nivolumab: (ONO-4538/BMS-936558) in people with Solid Tumor, run by Kyowa Kirin Co., Ltd. at 2 sites in Japan.
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 9 inclusion and 10 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: finished, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects reporting adverse events (time frame: From the first dose of study medications until 90 days after the last dose of study medication). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02476123, which also lists 1 linked publication.
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 11 Jun 2019.