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

Sponsor

Kyowa Kirin, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02301130

Collaborator

AstraZeneca (Industry)

Enrollment

Locations

Arms

39.3

Actual Duration (Months)

9.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumors	Biological: mogamulizumab Biological: MEDI4736 (Durvalumab) Biological: tremelimumab	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 26, 2014

Actual Primary Completion Date :

Dec 8, 2017

Actual Study Completion Date :

Mar 5, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.	Biological: mogamulizumab Mogamulizumab will be administered intravenously (IV). Other Names: KW-0761 POTELIGEO® Biological: MEDI4736 (Durvalumab) MEDI4736 will be administered intravenously (IV). Other Names: Durvalumab
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.	Biological: mogamulizumab Mogamulizumab will be administered intravenously (IV). Other Names: KW-0761 POTELIGEO® Biological: tremelimumab Tremelimumab will be administered intravenously (IV). Other Names: ticilimumab CP-675,206

Arm

Intervention/Treatment

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.

Biological: mogamulizumab

Mogamulizumab will be administered intravenously (IV).

Other Names:

KW-0761

POTELIGEO®

Biological: MEDI4736 (Durvalumab)

MEDI4736 will be administered intravenously (IV).

Other Names:

Durvalumab

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.

Biological: mogamulizumab

Mogamulizumab will be administered intravenously (IV).

Other Names:

KW-0761

POTELIGEO®

Biological: tremelimumab

Tremelimumab will be administered intravenously (IV).

Other Names:

ticilimumab

CP-675,206

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Angeles Clinic	Los Angeles	California	United States	90025
2	UCLA Hematology & Oncology Clinic	Los Angeles	California	United States	90095
3	Yale Cancer Center	New Haven	Connecticut	United States	06520-8028
4	H. Lee Moffitt Cancer Center	Tampa	Florida	United States	33612
5	Georgia Cancer Center	Augusta	Georgia	United States	30912
6	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10065
7	MD Anderson Cancer Center	Houston	Texas	United States	77030