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

Study Overview
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Brief Summary
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Mogamulizumab in Combination with MEDI4736 (Durvalumab) and Mogamulizumab in Combination with Tremelimumab in Subjects with Advanced Solid Tumors

Official Title
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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

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Biological: mogamulizumab
* Biological: MEDI4736 (Durvalumab)
* Biological: tremelimumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mogamulizumab + MEDI4736 (Durvalumab)<br>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. | Biological: mogamulizumab<br>* Mogamulizumab will be administered intravenously (IV).<br>* Other names: POTELIGEO®;Biological: MEDI4736 (Durvalumab)<br>* MEDI4736 will be administered intravenously (IV).<br>* Other names: Durvalumab;|
| Experimental: mogamulizumab + tremelimumab<br>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. | Biological: mogamulizumab<br>* Mogamulizumab will be administered intravenously (IV).<br>* Other names: POTELIGEO®;Biological: tremelimumab<br>* Tremelimumab will be administered intravenously (IV).<br>* Other names: CP-675,206;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects reporting adverse events |  | Screening through 90 days after the last dose of study medication | 
| Number of subjects reporting serious adverse events |  | Screening through 90 days after the last dose of study medication | 
| Percentage of subjects reporting serious adverse events |  | Screening through 90 days after the last dose of study medication | 
| Percentage of subjects reporting adverse events |  | Screening through 90 days after the last dose of study medication | 
| Number of subjects experiencing dose-limiting toxicity |  | First dose of study medications through 4 weeks after the last dose of study medication | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced solid tumors, solid tumors, mogamulizumab, MEDI4736 (Durvalumab), Tremelimumab, POTELIGEO®, KW-0761