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

Completed · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

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

Key facts

Study ID

NCT02301130

Run by

Kyowa Kirin, Inc.

People needed

64

Starts

2014-11-26

Expected to finish

2018-03-05

Last updated by the study team

2024-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years;
• Locally advanced or metastatic solid tumors;
• Histologically or cytologically confirmed disease;
• Failed or were intolerant to at least one prior systemic treatment regimen with oral or IV medications and have no additional therapy options known to prolong survival with the exception of PD-1 or PD-L1 blockade therapy for subjects who will be enrolled in treatment arm A. Subjects with non-small cell lung cancer must have received at least one platinum doublet regimen. Subjects with known epidermal growth factor receptor tyrosine kinase inhibitor activating mutations or anaplastic lymphoma kinase rearrangement must have also exhausted approved targeted therapy options;
• The subject has a tumor suitable for biopsy and is willing to undergo tumor biopsy, preferably of the primary tumor, within 28 days prior to Cycle 1/Visit Day 1;

You may not qualify if…

• Any concurrent chemotherapy, biologic, hormonal, radiation, or investigative therapy for cancer treatment within 21 days prior prior or within 6 weeks prior to Cycle 1/Visit Day 1 for nitrosoureas or mitomycin C;
• Concurrent or prior use of immunosuppressive medication within 28 days;
• Active or prior documented autoimmune, or inflammatory bowel disease, or inflammatory bowel disease. or systemic treatment for psoriasis within the past 5 years.;
• Prior hypersensitivity reaction to monoclonal antibodies, other therapeutic proteins, or immunotherapy.

Where it is running

• The Angeles Clinic — Los Angeles, California, United States
• UCLA Hematology & Oncology Clinic — Los Angeles, California, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• Georgia Cancer Center — Augusta, Georgia, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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