Advanced Solid Tumors
Conditions
Keywords
advanced solid tumors, solid tumors, mogamulizumab, MEDI4736 (Durvalumab), Tremelimumab, POTELIGEO®, KW-0761
Brief summary
Mogamulizumab in Combination with MEDI4736 (Durvalumab) and Mogamulizumab in Combination with Tremelimumab in Subjects with Advanced Solid Tumors
Interventions
BIOLOGICALmogamulizumab
Mogamulizumab will be administered intravenously (IV).
BIOLOGICALMEDI4736 (Durvalumab)
MEDI4736 will be administered intravenously (IV).
BIOLOGICALtremelimumab
Tremelimumab will be administered intravenously (IV).
Sponsors
AstraZeneca
Kyowa Kirin, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed