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

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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

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.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Number of patients with adverse events including intraoperative and postoperative complications

Secondary Outcome

 Objective tumor response rate according to RECIST v1.1

Condition

Gastric Cancer

Intervention

Mogamulizumab

Study Arms / Comparison Groups

 Cohort 1
Description:  KW-0761 (Mogamulizumab): 0.1 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

16

Start Date

March 2016

Completion Date

March 2020

Primary Completion Date

March 2020

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
      

Gender

All

Ages

20 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Hisashi Wada, M.D., Ph.D, , 

Location Countries

Japan

Location Countries

Japan

Administrative Informations


NCT ID

NCT02946671

Organization ID

KW0761-IIT-02


Responsible Party

Principal Investigator

Study Sponsor

Osaka University

Collaborators

 Kyowa Kirin Co., Ltd.

Study Sponsor

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


Verification Date

March 2020