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

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Kyowa Kirin, Inc.
Study ID
NCT02705105
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 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
Feb 29, 2016
Status verified
Apr 2024
Primary completion
Aug 22, 2018
Completion
Oct 10, 2018

Study Design

Enrollment
114 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose-Finding Cohort
    Cycle 1 Days 1, 8, 15, and 22: Dose Level 1 of Mogamulizumab + Nivolumab Subsequent Cycles Days 1 and 15: Dose Level 1 of Mogamulizumab + Nivolumab If \>1 patient has a DLT at first dose level, then the following cohort will be enrolled: Cycle 1 Days 1, 8, 15, and 22: Optional Dose Level of Mogamulizumab + Nivolumab Subsequent Cycles Days 1 and 15: Optional Dose Level of Mogamulizumab + Nivolumab
  • Experimental: Expansion Cohort
    Cycle 1 Days 1, 8, 15, and 22: Maximum Tolerated Dose of Mogamulizumab + Nivolumab Subsequent Cycles Days 1 and 15: Maximum Tolerated Dose of Mogamulizumab + Nivolumab Subjects will be separated further into cohorts by tumor type

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: From the first dose of study medications until 14 days after the last dose of study medication ]

Locations (15)

FacilityCityStateZIPSite coordinators
-GilbertArizona85234-
-GreenbraeCalifornia94904-
-Los AngelesCalifornia90033-
-JacksonvilleFlorida32224-
-AugustaGeorgia30912-
-ChicagoIllinois60637-
-BaltimoreMaryland21205-
-KalamazooMichigan49007-
-PiscatawayNew Jersey08854-
-AlbuquerqueNew Mexico87106-
-GoldsboroNorth Carolina27534-
-ColumbusOhio43210-
-PortlandOregon97213-
-PhiladelphiaPennsylvania19111-2497-
-HoustonTexas77030-

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