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Study of Combination Therapy With Mogamulizumab (KW-0761) and Nivolumab (ONO-4538/BMS-936558) in Subjects With Advanced Solid Tumors

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: NCT02476123
Recruitment Status : Completed
First Posted : June 19, 2015
Last Update Posted : June 11, 2019
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Kyowa Kirin Co., Ltd.

Study Description
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Brief Summary:
The purpose of this study is to characterize the safety and tolerability and determine the maximum tolerated dose (MTD) or the recommended fixed dose of the combinations of Mogamulizumab and Nivolumab in subjects with locally advanced or metastatic solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumor Biological: Mogamulizumab: KW-0761, Nivolumab: (ONO-4538/BMS-936558) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Combination Therapy With Mogamulizumab (KW-0761) and Nivolumab (ONO-4538/BMS-936558) in Subjects With Advanced Solid Tumors
Study Start Date : June 2015
Actual Primary Completion Date : February 7, 2018
Actual Study Completion Date : December 21, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Mogamulizumab+Nivolumab

During parts 1 and 2, Mogamulizumab and Nivolumab are administered at appropriate intervals.

Part 1 (Dose Escalation Part) During Cohort 1 to 2, Mogamulizumab and Nivolumab are administered in combination.

Part 2 (Expansion Part) Patients will be treated with maximum tolerated dose established in the dose escalation part for each combination.

 Biological: Mogamulizumab: KW-0761, Nivolumab: (ONO-4538/BMS-936558)
i.v. administration


Outcome Measures
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Primary Outcome Measures :
  1. Number of subjects reporting adverse events [ Time Frame: From the first dose of study medications until 90 days after the last dose of study medication ]
  2. Number of subjects reporting serious adverse events [ Time Frame: From the first dose of study medications until 90 days after the last dose of study medication ]
  3. Percentage of subjects reporting serious adverse events [ Time Frame: From the first dose of study medications until 90 days after the last dose of study medication ]
  4. Percentage of subjects reporting adverse events [ Time Frame: From the first dose of study medications until 90 days after the last dose of study medication ]
  5. Number of subjects experiencing dose-limiting toxicity [ Time Frame: For 28 days from the first dose of study medications ]

Eligibility Criteria
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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:

  • Subjects who voluntarily signed and dated Institutional Review Board approved informed consent form in accordance with regulatory and institutional guidelines.
  • Subjects who have progressed or have been intolerant to any standard treatment regimen or refused standard treatment, or for which adequate standard therapy does not exist.
  • Subjects who have evaluable lesion per guideline of Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Subjects with life expectancy > 12 weeks.
  • Subjects with Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
  • Potential child-bearing female who has agreed with contraception and not breast-feeding. For male who also has agreed with contraception.
  • Subjects who have adequate hematological, renal, hepatic and respiratory functions defined.
  • Must agree to present archival tumor tissues to sponsor or be willing to undergo a pre-treatment biopsy.
  • Histologically or cytologically confirmed locally advanced or metastatic solid tumors.

Exclusion Criteria:

  • Female subjects who are pregnant or breast-feeding.
  • Subjects with uncontrolled and significant inter-current illness.
  • Subjects with known central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Subjects who have been previously treated with an anti-programmed death 1 (PD-1), anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
  • Subjects who have been previously treated with Mogamulizumab.
  • Subjects with any prior Grade ≥ 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE.
  • Subjects with a history of severe hypersensitivity reactions to drugs.
  • Subjects who have been received chemotherapies, immunotherapy, biologic or hormonal therapies, another investigational drug, radiation or major surgery for cancer treatment within 28 days or 42 days (for nitrosourea or mitomycin C) prior to Cycle 1 Day 1.
  • Subjects who have known active autoimmune disease or syndrome.
  • Subjects who have active inflammatory bowel disease, irritable bowel disease, celiac disease, or other serious GI chronic conditions associated with diarrhea.
Contacts and Locations
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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): NCT02476123


Locations
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Japan
Chiba, Japan
Tokyo, Japan
Sponsors and Collaborators
Kyowa Kirin Co., Ltd.
Ono Pharmaceutical Co. Ltd
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kyowa Kirin Co., Ltd.
ClinicalTrials.gov Identifier: NCT02476123    
Other Study ID Numbers: 0761-013
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Neoplasms
Nivolumab
Mogamulizumab
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action