Gastric CancerPhase 1NCT02946671
Study of Pre-operative Combination Therapy With Mogamulizumab and Nivolumab Against Solid Cancer Patients
A Phase 1 study testing Mogamulizumab and Nivolumab in people with Gastric Cancer and Esophageal Cancer, run by Osaka University at 1 site in Japan.
Trial summary
To assess the safety of preoperative combination therapy with KW-0761 (anti-CCR4) and ONO-4538 (anti-PD-1). To assess the behavior of immune cells in peripheral blood and tumor. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Cancer, Esophageal Cancer, Lung Cancer
- What is being tested?
- Mogamulizumab and Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2016to Mar 2020
- 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
- Patients who enable to have standard operation
- Patients who refuse standard preoperative chemotherapy and are diagnosed with following cancers; gastric adenocarcinoma, esophageal squamous cell carcinoma, non-small-cell lung carcinoma, renal cell carcinoma or oral squamous cell carcinoma
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Patients with no serious disorder of major organs (born marrow, heart, lung, liver and kidney)
- Patients with written informed consent
- Patients who have measurable target lesion
- Patients who are enable to undergo biopsy for sampling tumor tissue
Who cannot join
- Known or previous autoimmune disease
- Known or suspected interstitial lung disease (ILD)
- Patients with history of serious anaphylaxis induced by antibody preparation
- Uncontrollable hypertension
- Uncontrollable endocrine disease
- Patients who have active inflammatory bowel disease or other serious GI chronic conditions associated with diarrhea
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- Uncontrollable diabetes
- Prior therapy with sustained anticancer agents, radiotherapy or surgery for primary disease
- Pregnant or lactating females, female and male patients who cannot agree to practice the adequate birth control after the consent during the study
- Known or suspected infection or inflammatory disease
- Prior therapy with hematopoietic stem cell transplantation
- Known or suspected central nervous system (CNS) involvement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of Pre-operative Combination Therapy With Mogamulizumab (Anti-CCR4) and Nivolumab (Anti-PD-1) Against Solid Cancer Patients
To assess the safety of preoperative combination therapy with KW-0761 (anti-CCR4) and ONO-4538 (anti-PD-1).
To assess the behavior of immune cells in peripheral blood and tumor.
- Conditions
- Gastric Cancer, Esophageal Cancer, Lung Cancer, Renal Cancer, Oral Cancer
- Being tested
- Mogamulizumab, Nivolumab
- Medical subject headings
- Stomach Neoplasms, Esophageal Neoplasms, Lung Neoplasms, Kidney Neoplasms, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MogamulizumabBiological
Also called KW-0761
Mogamulizumab (0.1, 0.3 or 1.0 mg/kg) is administered.
NivolumabBiological
Also called ONO-4538
Nivolumab (3.0 mg/kg) is administered.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | KW-0761 (Mogamulizumab): 0.1 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times Receives: Biological: Mogamulizumab; Biological: Nivolumab |
| Cohort 2 | Experimental | KW-0761 (Mogamulizumab): 0.3 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times Receives: Biological: Mogamulizumab; Biological: Nivolumab |
| Cohort 3 | Experimental | KW-0761 (Mogamulizumab): 1.0 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times Receives: Biological: Mogamulizumab; Biological: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events including intraoperative and postoperative complications
Confirm the toxicity profile, which is measured by the degree of grade and seriousness, duration, causality, classification, etc. of the adverse events.
Measured: from first administration to 60 days after the final administration or to 30 days after the standard operation
Rate of Foxp3-positive patients in tumor by immunohistochemical analysis
Measured: from baseline until standard operation, an average of 7 weeks
Secondary outcomes (2)
Objective tumor response rate according to RECIST v1.1
Measured: from baseline to 6 weeks after the first administration
Rate of Treg decrease in peripheral blood mononuclear cell (PBMC)
Measured: from baseline to 60 days after the final administration or to 30 days after the standard operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2020
- Study completionMar 2020
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 Gastric CancerStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osaka University
- Sponsor type
- University, hospital or other
- Collaborators
- Kyowa Kirin Co., Ltd., Ono Pharmaceutical Co., Ltd., Clinical Study Support, Inc., Fiverings Co., Ltd.
- Responsible party
- Principal investigator, Hisashi Wada, Osaka University
- Investigators
- Hisashi Wada, M.D., Ph.D, Study chair, Department of Clinical Research in Tumor Immunology, Graduate School of Medicine, Osaka University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946671
- Sponsor's protocol ID
- KW0761-IIT-02
- Status last verified
- Mar 2020
- First submitted
- 5 Oct 2016
- Last updated
- 6 Mar 2020
- Results posted
- No
Publications
Jinushi K, Saito T, Kurose K, Suzuki S, Kojima T, Takahara T, Makino T, Ogawa T, Nishikawa H, Kakimi K, Iida S, Nakajima J, Doki Y, Oka M, Ueda R, Wada H. Phase I study on neoadjuvant combination immunotherapy with mogamulizumab and nivolumab for solid tumors. J Immunother Cancer. 2025 Apr 2;13(4):e010634. doi: 10.1136/jitc-2024-010634.
PubMed 40180420
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Pre-operative Combination Therapy With Mogamulizumab (Anti-CCR4) and Nivolumab (Anti-PD-1) Against Solid Cancer Patients
- ClinicalTrials.gov ID
- NCT02946671
- Acronym / sponsor ID
- KW0761-IIT-02
- Conditions
- Gastric Cancer, Esophageal Cancer, Lung Cancer, Renal Cancer, Oral Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Osaka UniversityUniversity, hospital or other
- Collaborators
- Kyowa Kirin Co., Ltd., Ono Pharmaceutical Co., Ltd., Clinical Study Support, Inc., Fiverings Co., Ltd.
- Study start
- Mar 2016
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 27 Oct 2016 (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.
To assess the safety of preoperative combination therapy with KW-0761 (anti-CCR4) and ONO-4538 (anti-PD-1).
To assess the behavior of immune cells in peripheral blood and tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: Mogamulizumab, Biological: NivolumabKW-0761 (Mogamulizumab): 0.1 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times |
| Cohort 2 | Experimental | Biological: Mogamulizumab, Biological: NivolumabKW-0761 (Mogamulizumab): 0.3 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times |
| Cohort 3 | Experimental | Biological: Mogamulizumab, Biological: NivolumabKW-0761 (Mogamulizumab): 1.0 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who enable to have standard operation
- Patients who refuse standard preoperative chemotherapy and are diagnosed with following cancers; gastric adenocarcinoma, esophageal squamous cell carcinoma, non-small-cell lung carcinoma, renal cell carcinoma or oral squamous cell carcinoma
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Patients with no serious disorder of major organs (born marrow, heart, lung, liver and kidney)
- Patients with written informed consent
Key exclusion criteria (12 listed)
- Known or previous autoimmune disease
- Known or suspected interstitial lung disease (ILD)
- Patients with history of serious anaphylaxis induced by antibody preparation
- Uncontrollable hypertension
- Uncontrollable endocrine disease
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 |
|---|---|---|
| MogamulizumabAlso: KW-0761Mogamulizumab (0.1, 0.3 or 1.0 mg/kg) is administered. | Biological | Cohort 1, Cohort 2, Cohort 3 |
| NivolumabAlso: ONO-4538Nivolumab (3.0 mg/kg) is administered. | Biological | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Number of patients with adverse events including intraoperative and postoperative complications
Time frame: from first administration to 60 days after the final administration or to 30 days after the standard operation
Confirm the toxicity profile, which is measured by the degree of grade and seriousness, duration, causality, classification, etc. of the adverse events.
Rate of Foxp3-positive patients in tumor by immunohistochemical analysis
Time frame: from baseline until standard operation, an average of 7 weeks
2 secondary outcomes
Objective tumor response rate according to RECIST v1.1
Time frame: from baseline to 6 weeks after the first administration
Rate of Treg decrease in peripheral blood mononuclear cell (PBMC)
Time frame: from baseline to 60 days after the final administration or to 30 days after the standard operation
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 6 Mar 2020.
- Derived from this study: PubMed 40180420Jinushi K, Saito T, Kurose K, Suzuki S, Kojima T, Takahara T, Makino T, Ogawa T, Nishikawa H, Kakimi K, Iida S, Nakajima J, Doki Y, Oka M, Ueda R, Wada H. Phase I study on neoadjuvant combination immunotherapy with mogamulizumab and nivolumab for solid tumors. J Immunother Cancer. 2025 Apr 2;13(4):e010634. doi: 10.1136/jitc-2024-010634.
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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.
Hisashi Wada, M.D., Ph.D study chair
Department of Clinical Research in Tumor Immunology, Graduate School of Medicine, Osaka University
1 site 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 and Nivolumab in people with Gastric Cancer and Esophageal Cancer, run by Osaka University at 1 site 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 7 inclusion and 12 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 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 patients with adverse events including intraoperative and postoperative complications (time frame: from first administration to 60 days after the final administration or to 30 days after the standard operation). The study lists 2 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 NCT02946671, 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 6 Mar 2020.