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

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02301130
• Other study ID #: 0761-012
• Status: Completed
• Phase: Phase 1
• Start date: November 26, 2014
• Est. completion date: March 5, 2018

Study information

• Verified date: April 2024
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 5, 2018
• Est. primary completion date: December 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Biological:
• mogamulizumab
Mogamulizumab will be administered intravenously (IV).
• MEDI4736 (Durvalumab)
MEDI4736 will be administered intravenously (IV).
• tremelimumab
Tremelimumab will be administered intravenously (IV).

Locations

Country	Name	City	State
United States	Georgia Cancer Center	Augusta	Georgia
United States	MD Anderson Cancer Center	Houston	Texas
United States	The Angeles Clinic	Los Angeles	California
United States	UCLA Hematology & Oncology Clinic	Los Angeles	California
United States	Yale Cancer Center	New Haven	Connecticut
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	H. Lee Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Kyowa Kirin, Inc.	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects reporting adverse events		Screening through 90 days after the last dose of study medication
Primary	Number of subjects reporting serious adverse events		Screening through 90 days after the last dose of study medication
Primary	Percentage of subjects reporting serious adverse events		Screening through 90 days after the last dose of study medication
Primary	Percentage of subjects reporting adverse events		Screening through 90 days after the last dose of study medication
Primary	Number of subjects experiencing dose-limiting toxicity		First dose of study medications through 4 weeks after the last dose of study medication