Study of Mogamulizumab + MEDI4736 (Durvalumab) and Mogamulizumab + Tremelimumab in Subjects w/ Advanced Solid Tumors
April 23, 2024 updated by: Kyowa Kirin, Inc.
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90095
- UCLA Hematology & Oncology Clinic
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Los Angeles, California, United States, 90025
- The Angeles Clinic
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Connecticut
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New Haven, Connecticut, United States, 06520-8028
- Yale Cancer Center
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Florida
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Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center
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Georgia
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Augusta, Georgia, United States, 30912
- Georgia Cancer Center
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New York
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
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Texas
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Houston, Texas, United States, 77030
- MD Anderson Cancer Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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)
|
Mogamulizumab will be administered intravenously (IV).
Other Names:
MEDI4736 will be administered intravenously (IV).
Other Names:
|
|
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)
|
Mogamulizumab will be administered intravenously (IV).
Other Names:
Tremelimumab will be administered intravenously (IV).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of subjects reporting adverse events
Time Frame: Screening through 90 days after the last dose of study medication
|
Screening through 90 days after the last dose of study medication
|
|
Number of subjects reporting serious adverse events
Time Frame: Screening through 90 days after the last dose of study medication
|
Screening through 90 days after the last dose of study medication
|
|
Percentage of subjects reporting serious adverse events
Time Frame: Screening through 90 days after the last dose of study medication
|
Screening through 90 days after the last dose of study medication
|
|
Percentage of subjects reporting adverse events
Time Frame: Screening through 90 days after the last dose of study medication
|
Screening through 90 days after the last dose of study medication
|
|
Number of subjects experiencing dose-limiting toxicity
Time Frame: First dose of study medications through 4 weeks after the last dose of study medication
|
First dose of study medications through 4 weeks after the last dose of study medication
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 26, 2014
Primary Completion (Actual)
December 8, 2017
Study Completion (Actual)
March 5, 2018
Study Registration Dates
First Submitted
November 21, 2014
First Submitted That Met QC Criteria
November 21, 2014
First Posted (Estimated)
November 25, 2014
Study Record Updates
Last Update Posted (Actual)
April 25, 2024
Last Update Submitted That Met QC Criteria
April 23, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0761-012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.