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Study of Pre-operative Combination Therapy With Mogamulizumab and Nivolumab Against Solid Cancer Patients

Primary Purpose

Gastric Cancer, Esophageal Cancer, Lung Cancer

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Mogamulizumab
Nivolumab
Sponsored by
Osaka University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Osaka University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

KW-0761 (Mogamulizumab): 0.1 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times

KW-0761 (Mogamulizumab): 0.3 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times

KW-0761 (Mogamulizumab): 1.0 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times

Outcomes

Primary Outcome Measures

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.
Rate of Foxp3-positive patients in tumor by immunohistochemical analysis

Secondary Outcome Measures

Objective tumor response rate according to RECIST v1.1
Rate of Treg decrease in peripheral blood mononuclear cell (PBMC)

Full Information

First Posted
October 5, 2016
Last Updated
March 4, 2020
Sponsor
Osaka University
Collaborators
Kyowa Kirin Co., Ltd., Ono Pharmaceutical Co. Ltd, Clinical Study Support, Inc., Fiverings Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02946671
Brief Title
Study of Pre-operative Combination Therapy With Mogamulizumab and Nivolumab Against Solid Cancer Patients
Official Title
Phase I Study of Pre-operative Combination Therapy With Mogamulizumab (Anti-CCR4) and Nivolumab (Anti-PD-1) Against Solid Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
March 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Osaka University
Collaborators
Kyowa Kirin Co., Ltd., Ono Pharmaceutical Co. Ltd, Clinical Study Support, Inc., Fiverings Co., Ltd.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Esophageal Cancer, Lung Cancer, Renal Cancer, Oral Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
KW-0761 (Mogamulizumab): 0.1 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
KW-0761 (Mogamulizumab): 0.3 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
KW-0761 (Mogamulizumab): 1.0 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times
Intervention Type
Biological
Intervention Name(s)
Mogamulizumab
Other Intervention Name(s)
KW-0761
Intervention Description
Mogamulizumab (0.1, 0.3 or 1.0 mg/kg) is administered.
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
ONO-4538
Intervention Description
Nivolumab (3.0 mg/kg) is administered.
Primary Outcome Measure Information:
Title
Number of patients with adverse events including intraoperative and postoperative complications
Description
Confirm the toxicity profile, which is measured by the degree of grade and seriousness, duration, causality, classification, etc. of the adverse events.
Time Frame
from first administration to 60 days after the final administration or to 30 days after the standard operation
Title
Rate of Foxp3-positive patients in tumor by immunohistochemical analysis
Time Frame
from baseline until standard operation, an average of 7 weeks
Secondary Outcome Measure Information:
Title
Objective tumor response rate according to RECIST v1.1
Time Frame
from baseline to 6 weeks after the first administration
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hisashi Wada, M.D., Ph.D
Organizational Affiliation
Department of Clinical Research in Tumor Immunology, Graduate School of Medicine, Osaka University
Official's Role
Study Chair
Facility Information:
Facility Name
Osaka University
City
Suita
State/Province
Osaka
ZIP/Postal Code
5650871
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Study of Pre-operative Combination Therapy With Mogamulizumab and Nivolumab Against Solid Cancer Patients

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