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

Sponsor
Kyowa Kirin Co., Ltd.
Study ID
NCT02476123
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 30, 2015
Status verified
Jun 2019
Primary completion
Feb 7, 2018
Completion
Dec 21, 2018

Study Design

Enrollment
118 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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 ]

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