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

March 4, 2020 updated by: Hisashi Wada, Osaka University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Osaka
      • Suita, Osaka, Japan, 5650871
        • Osaka University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
KW-0761 (Mogamulizumab): 0.1 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times
Biological: Mogamulizumab
Mogamulizumab (0.1, 0.3 or 1.0 mg/kg) is administered.
Other Names:
  • KW-0761
Biological: Nivolumab
Nivolumab (3.0 mg/kg) is administered.
Other Names:
  • ONO-4538
Experimental: Cohort 2
KW-0761 (Mogamulizumab): 0.3 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times
Biological: Mogamulizumab
Mogamulizumab (0.1, 0.3 or 1.0 mg/kg) is administered.
Other Names:
  • KW-0761
Biological: Nivolumab
Nivolumab (3.0 mg/kg) is administered.
Other Names:
  • ONO-4538
Experimental: Cohort 3
KW-0761 (Mogamulizumab): 1.0 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times
Biological: Mogamulizumab
Mogamulizumab (0.1, 0.3 or 1.0 mg/kg) is administered.
Other Names:
  • KW-0761
Biological: Nivolumab
Nivolumab (3.0 mg/kg) is administered.
Other Names:
  • ONO-4538

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: from baseline until standard operation, an average of 7 weeks
from baseline until standard operation, an average of 7 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective tumor response rate according to RECIST v1.1
Time Frame: from baseline to 6 weeks after the first administration
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
from baseline to 60 days after the final administration or to 30 days after the standard operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Osaka University

Collaborators

Ono Pharmaceutical Co. Ltd
Kyowa Kirin Co., Ltd.
Clinical Study Support, Inc.
Fiverings Co., Ltd.

Investigators

  • Study Chair: Hisashi Wada, M.D., Ph.D, Department of Clinical Research in Tumor Immunology, Graduate School of Medicine, Osaka University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

October 5, 2016

First Submitted That Met QC Criteria

October 25, 2016

First Posted (Estimate)

October 27, 2016

Study Record Updates

Last Update Posted (Actual)

March 6, 2020

Last Update Submitted That Met QC Criteria

March 4, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KW0761-IIT-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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