Clinical trial NCT02301130: Study of Mogamulizumab + MEDI4736 (Durvalumab) and Mogamulizumab + Tremelimumab in Subjects w/ Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: advanced solid tumors
solid tumors
mogamulizumab
MEDI4736 (Durvalumab)
Tremelimumab
POTELIGEO®
KW-0761
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2014-11-25
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of subjects reporting adverse events
timeFrame: Screening through 90 days after the last dose of study medication
measure: Number of subjects reporting serious adverse events
timeFrame: Screening through 90 days after the last dose of study medication
measure: Percentage of subjects reporting serious adverse events
timeFrame: Screening through 90 days after the last dose of study medication
measure: Percentage of subjects reporting adverse events
timeFrame: Screening through 90 days after the last dose of study medication
measure: Number of subjects experiencing dose-limiting toxicity
timeFrame: First dose of study medications through 4 weeks after the last dose of study medication
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: The Angeles Clinic
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology & Oncology Clinic
state: California
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Augusta
country: United States
facility: Georgia Cancer Center
state: Georgia
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
References:
citation: Zamarin D, Hamid O, Nayak-Kapoor A, Sahebjam S, Sznol M, Collaku A, Fox FE, Marshall MA, Hong DS. Mogamulizumab in Combination with Durvalumab or Tremelimumab in Patients with Advanced Solid Tumors: A Phase I Study. Clin Cancer Res. 2020 Sep 1;26(17):4531-4541. doi: 10.1158/1078-0432.CCR-20-0328. Epub 2020 Jun 25.