Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02946671
Recruitment Status : Completed
First Posted : October 27, 2016
Last Update Posted : March 6, 2020
Sponsor:
Collaborators:
Kyowa Kirin Co., Ltd.
Ono Pharmaceutical Co. Ltd
Clinical Study Support, Inc.
Fiverings Co., Ltd.
Information provided by (Responsible Party):
Hisashi Wada, Osaka University

Tracking Information
First Submitted Date  ICMJE October 5, 2016
First Posted Date  ICMJE October 27, 2016
Last Update Posted Date March 6, 2020
Study Start Date  ICMJE March 2016
Actual Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2016)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Pre-operative Combination Therapy With Mogamulizumab and Nivolumab Against Solid Cancer Patients
Official Title  ICMJE Phase I Study of Pre-operative Combination Therapy With Mogamulizumab (Anti-CCR4) and Nivolumab (Anti-PD-1) Against Solid Cancer Patients
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gastric Cancer
  • Esophageal Cancer
  • Lung Cancer
  • Renal Cancer
  • Oral Cancer
Intervention  ICMJE
  • Biological: Mogamulizumab
    Mogamulizumab (0.1, 0.3 or 1.0 mg/kg) is administered.
    Other Name: KW-0761
  • Biological: Nivolumab
    Nivolumab (3.0 mg/kg) is administered.
    Other Name: ONO-4538
Study Arms  ICMJE
  • 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
    Interventions:
    • Biological: Mogamulizumab
    • Biological: Nivolumab
  • 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
    Interventions:
    • Biological: Mogamulizumab
    • Biological: Nivolumab
  • 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
    Interventions:
    • Biological: Mogamulizumab
    • Biological: Nivolumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2020)
16
Original Estimated Enrollment  ICMJE
 (submitted: October 25, 2016)
18
Actual Study Completion Date  ICMJE March 2020
Actual Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02946671
Other Study ID Numbers  ICMJE KW0761-IIT-02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hisashi Wada, Osaka University
Study Sponsor  ICMJE Osaka University
Collaborators  ICMJE
  • Kyowa Kirin Co., Ltd.
  • Ono Pharmaceutical Co. Ltd
  • Clinical Study Support, Inc.
  • Fiverings Co., Ltd.
Investigators  ICMJE
Study Chair: Hisashi Wada, M.D., Ph.D Department of Clinical Research in Tumor Immunology, Graduate School of Medicine, Osaka University
PRS Account Osaka University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP