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

June 9, 2019 updated by: Kyowa Kirin Co., Ltd.

Phase 1 Study of Combination Therapy With Mogamulizumab (KW-0761) and Nivolumab (ONO-4538/BMS-936558) in Subjects With Advanced Solid Tumors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chiba, Japan
      • Tokyo, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From the first dose of study medications until 90 days after the last dose of study medication
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
From the first dose of study medications until 90 days after the last dose of study medication
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
From the first dose of study medications until 90 days after the last dose of study medication
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
From the first dose of study medications until 90 days after the last dose of study medication
Number of subjects experiencing dose-limiting toxicity
Time Frame: For 28 days from the first dose of study medications
For 28 days from the first dose of study medications

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin Co., Ltd.

Collaborators

Ono Pharmaceutical Co. Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

February 7, 2018

Study Completion (Actual)

December 21, 2018

Study Registration Dates

First Submitted

June 10, 2015

First Submitted That Met QC Criteria

June 16, 2015

First Posted (Estimate)

June 19, 2015

Study Record Updates

Last Update Posted (Actual)

June 11, 2019

Last Update Submitted That Met QC Criteria

June 9, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0761-013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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