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



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/3/2018
Start Date:November 26, 2014
End Date:March 5, 2018

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Phase 1 Study of Mogamulizumab (KW-0761) in Combination With MEDI4736 (Durvalumab) and Mogamulizumab in Combination With Tremelimumab in Subjects With Advanced Solid Tumors

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


Inclusion Criteria:

- 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;

Exclusion Criteria:

- 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.
We found this trial at
7
sites
333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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New Haven, CT
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1410 Laney Walker Boulevard
Augusta, Georgia 30912
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Augusta, GA
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Houston, Texas 77030
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Houston, TX
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Los Angeles, California 90025
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Los Angeles, CA
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Los Angeles, California 90095
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Los Angeles, CA
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Tampa, Florida 33612
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Tampa, FL
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