Study of Mogamulizumab + MEDI4736 (Durvalumab) and Mogamulizumab + Tremelimumab in Subjects w/ Advanced Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
Kyowa Kirin, Inc.
Study ID
NCT02301130
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

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

Interventions

  • mogamulizumab — BIOLOGICAL
    Mogamulizumab will be administered intravenously (IV).
  • MEDI4736 (Durvalumab) — BIOLOGICAL
    MEDI4736 will be administered intravenously (IV).
  • tremelimumab — BIOLOGICAL
    Tremelimumab will be administered intravenously (IV).

Study Details

Mogamulizumab in Combination with MEDI4736 (Durvalumab) and Mogamulizumab in Combination with Tremelimumab in Subjects with Advanced Solid Tumors

Key Dates

Start date
Nov 26, 2014
Status verified
Apr 2024
Primary completion
Dec 8, 2017
Completion
Mar 5, 2018

Study Design

Enrollment
64 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: mogamulizumab + MEDI4736 (Durvalumab)
    During Parts 1 and 2, mogamulizumab and MEDI4736 (Durvalumab) are administered at appropriate intervals. Part 1 (Dose Escalation Phase) \- During Cohort 1A to 4A, increased doses of mogamulizumab and MEDI4736 (Durvalumab) are administered. Part 2 (Cohort Expansion Phase) * Patients will be treated with maximum tolerated dose established in the Dose Escalation Phase for each combination.
  • Experimental: mogamulizumab + tremelimumab
    During Parts 1 and 2, mogamulizumab and tremelimumab are administered at appropriate intervals. Part 1 (Dose Escalation Phase) \- During Cohort 1B to 4B, increased doses of mogamulizumab and tremelimumab are administered. Part 2 (Cohort Expansion Phase) * Patients will be treated with maximum tolerated dose established in the Dose Escalation Phase for each combination.

Primary Outcome Measure

Number of subjects reporting adverse events [ Time Frame: Screening through 90 days after the last dose of study medication ]

Locations (7)

FacilityCityStateZIPSite coordinators
The Angeles ClinicLos AngelesCalifornia90025-
UCLA Hematology & Oncology ClinicLos AngelesCalifornia90095-
Yale Cancer CenterNew HavenConnecticut06520-8028-
H. Lee Moffitt Cancer CenterTampaFlorida33612-
Georgia Cancer CenterAugustaGeorgia30912-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Los Angeles, CA

By research site
The Angeles Clinic· Los Angeles, CAUCLA Hematology & Oncology Clinic· Los Angeles, CAYale Cancer Center· New Haven, CTH. Lee Moffitt Cancer Center· Tampa, FLGeorgia Cancer Center· Augusta, GAMemorial Sloan-Kettering Cancer Center· New York, NY

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