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

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ClinicalTrials.gov Identifier: NCT02476123
Recruitment Status : Active, not recruiting
First Posted : June 19, 2015
Last Update Posted : July 25, 2018
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Kyowa Hakko 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)
Estimated Enrollment : 108 participants
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
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

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
Japan
Chiba, Japan
Tokyo, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd
Ono Pharmaceutical Co. Ltd
More Information
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Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT02476123     History of Changes
Other Study ID Numbers: 0761-013
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs