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Study of Mogamulizumab + Nivolumab in Subjects w/Locally Advanced or Metastatic Solid Tumors

Cancer Clinical Trial

Official title:
Open-label, Multicenter, Phase 1/2 Study of Mogamulizumab in Combination With Nivolumab in Subjects With Locally Advanced or Metastatic Solid Tumors

Clinical Trial 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.

Clinical Trial Description

This is a multicenter, Phase 1/2 open-label, dose-finding and cohort expansion study of the anti-CCR4 antibody mogamulizumab in combination therapy with the anti-PD-1 antibody nivolumab in adult subjects with locally advanced or metastatic solid tumors. Phase 1 will identify the maximum tolerated dose (MTD) or the highest protocol-defined dose in absence of exceeding the MTD, of the combination regimen of mogamulizumab and nivolumab subjects. Phase 1 will enroll up to 12 subjects. Phase 2 will explore the safety, efficacy and anti-tumor activity of the highest tolerated dose of the combination regimen. Phase 2 will enroll up to 184 subjects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02705105
Study type Interventional
Source Kyowa Kirin Co., Ltd.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date February 2016
Completion date October 10, 2018
View Details
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