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

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ClinicalTrials.gov Identifier: NCT02946671
Recruitment Status : Recruiting
First Posted : October 27, 2016
Last Update Posted : January 8, 2019
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

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.


Condition or disease Intervention/treatment Phase
Gastric Cancer Esophageal Cancer Lung Cancer Renal Cancer Oral Cancer Biological: Mogamulizumab Biological: Nivolumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Pre-operative Combination Therapy With Mogamulizumab (Anti-CCR4) and Nivolumab (Anti-PD-1) Against Solid Cancer Patients
Study Start Date : March 2016
Estimated Primary Completion Date : March 2020


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 Name: KW-0761

Biological: Nivolumab
Nivolumab (3.0 mg/kg) is administered.
Other Name: 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 Name: KW-0761

Biological: Nivolumab
Nivolumab (3.0 mg/kg) is administered.
Other Name: 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 Name: KW-0761

Biological: Nivolumab
Nivolumab (3.0 mg/kg) is administered.
Other Name: ONO-4538




Primary Outcome Measures :
  1. 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.

  2. Rate of Foxp3-positive patients in tumor by immunohistochemical analysis [ Time Frame: from baseline until standard operation, an average of 7 weeks ]

Secondary Outcome Measures :
  1. Objective tumor response rate according to RECIST v1.1 [ Time Frame: from baseline to 6 weeks after the first administration ]
  2. 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 ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02946671


Contacts
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Contact: Tatsushi Goto, Ph.D. +81-6-6358-7004 gotou@fiverings.co.jp

Locations
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Japan
Osaka University Recruiting
Suita, Osaka, Japan, 5650871
Contact: Hisashi Wada         
Sponsors and Collaborators
Osaka University
Kyowa Kirin Co., Ltd.
Ono Pharmaceutical Co. Ltd
Clinical Study Support, Inc.
Fiverings Co., Ltd.
Investigators
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Study Chair: Hisashi Wada, M.D., Ph.D Department of Clinical Research in Tumor Immunology, Graduate School of Medicine, Osaka University

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Responsible Party: Hisashi Wada, Professor, Osaka University
ClinicalTrials.gov Identifier: NCT02946671     History of Changes
Other Study ID Numbers: KW0761-IIT-02
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Kidney Neoplasms
Mouth Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Mouth Diseases
Stomatognathic Diseases
Nivolumab
Mogamulizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents