Study of Mogamulizumab + Nivolumab in Subjects w/Locally Advanced or Metastatic 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: NCT02705105|
Recruitment Status : Completed
First Posted : March 10, 2016
Last Update Posted : September 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor Cancer Carcinoma Hepatocellular Carcinoma HCC||Biological: Mogamulizumab + Nivolumab||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||114 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-label, Multicenter, Phase 1/2 Study of Mogamulizumab in Combination With Nivolumab in Subjects With Locally Advanced or Metastatic Solid Tumors|
|Study Start Date :||December 2015|
|Actual Primary Completion Date :||August 22, 2018|
|Actual Study Completion Date :||October 10, 2018|
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 + Nivolumab
Other Name: Mogamulizumab: KW-0761, Nivolumab: ONO-4538/BMS-936558
- Maximum Tolerated Dose (MTD) [ Time Frame: From the first dose of study medications until 14 days after the last dose of study medication ]combination regimen of mogamulizumab and nivolumab in subjects with locally advanced or metastatic solid tumors.
- Number of subjects experiencing dose-limiting toxicity [ Time Frame: From the first dose of study medications until 14 days after the last dose of study medication ]combination of mogamulizumab and nivolumab
- Objective tumor response rate according to RECIST [ Time Frame: From baseline to every 12 weeks, until data cut off ]combination of mogamulizumab and nivolumab
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): NCT02705105
|United States, Arizona|
|Gilbert, Arizona, United States, 85234|
|United States, California|
|Greenbrae, California, United States, 94904|
|Los Angeles, California, United States, 90033|
|United States, Florida|
|Jacksonville, Florida, United States, 32224|
|United States, Georgia|
|Augusta, Georgia, United States, 30912|
|United States, Illinois|
|Chicago, Illinois, United States, 60637|
|United States, Maryland|
|Baltimore, Maryland, United States, 21205|
|United States, Michigan|
|Kalamazoo, Michigan, United States, 49007|
|United States, New Jersey|
|Piscataway, New Jersey, United States, 08854|
|United States, New Mexico|
|Albuquerque, New Mexico, United States, 87106|
|United States, North Carolina|
|Goldsboro, North Carolina, United States, 27534|
|United States, Ohio|
|Columbus, Ohio, United States, 43210|
|United States, Oregon|
|Portland, Oregon, United States, 97213|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|United States, Texas|
|Houston, Texas, United States, 77030|