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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-26

Study Completion Date

2018-03-05

Brief Summary

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

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Detailed Description

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Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

mogamulizumab

Intervention Type BIOLOGICAL

Mogamulizumab will be administered intravenously (IV).

MEDI4736 (Durvalumab)

Intervention Type BIOLOGICAL

MEDI4736 will be administered intravenously (IV).

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.

Group Type EXPERIMENTAL

mogamulizumab

Intervention Type BIOLOGICAL

Mogamulizumab will be administered intravenously (IV).

tremelimumab

Intervention Type BIOLOGICAL

Tremelimumab will be administered intravenously (IV).

Interventions

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mogamulizumab

Mogamulizumab will be administered intravenously (IV).

Intervention Type BIOLOGICAL

MEDI4736 (Durvalumab)

MEDI4736 will be administered intravenously (IV).

Intervention Type BIOLOGICAL

tremelimumab

Tremelimumab will be administered intravenously (IV).

Intervention Type BIOLOGICAL

Other Intervention Names

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KW-0761 POTELIGEO® Durvalumab ticilimumab CP-675,206

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No