Study of Pre-operative Combination Therapy With Mogamulizumab and Nivolumab Against Solid Cancer Patients
Phase I Study of Pre-operative Combination Therapy With Mogamulizumab (Anti-CCR4) and Nivolumab (Anti-PD-1) Against Solid Cancer Patients
1 other identifier
interventional
16
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 gastric-cancer
Started Mar 2016
Typical duration for phase_1 gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 5, 2016
CompletedFirst Posted
Study publicly available on registry
October 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedMarch 6, 2020
March 1, 2020
4 years
October 5, 2016
March 4, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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
from baseline until standard operation, an average of 7 weeks
Secondary Outcomes (2)
Objective tumor response rate according to RECIST v1.1
from baseline to 6 weeks after the first administration
Rate of Treg decrease in peripheral blood mononuclear cell (PBMC)
from baseline to 60 days after the final administration or to 30 days after the standard operation
Study Arms (3)
Cohort 1
EXPERIMENTALKW-0761 (Mogamulizumab): 0.1 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times
Cohort 2
EXPERIMENTALKW-0761 (Mogamulizumab): 0.3 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times
Cohort 3
EXPERIMENTALKW-0761 (Mogamulizumab): 1.0 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times
Interventions
Mogamulizumab (0.1, 0.3 or 1.0 mg/kg) is administered.
Nivolumab (3.0 mg/kg) is administered.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Osaka Universitylead
- Kyowa Kirin Co., Ltd.collaborator
- Ono Pharmaceutical Co. Ltdcollaborator
- Clinical Study Support, Inc.collaborator
- Fiverings Co., Ltd.collaborator
Study Sites (1)
Osaka University
Suita, Osaka, 5650871, Japan
Related Publications (1)
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.
PMID: 40180420DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hisashi Wada, M.D., Ph.D
Department of Clinical Research in Tumor Immunology, Graduate School of Medicine, Osaka University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 5, 2016
First Posted
October 27, 2016
Study Start
March 1, 2016
Primary Completion
March 1, 2020
Study Completion
March 1, 2020
Last Updated
March 6, 2020
Record last verified: 2020-03