A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, PK and Preliminary Anti-tumor Activity when given as a monotherapy of Tremelimumab or Tremelimumab in combination with MEDI4736 in Japanese Patients with Advanced Solid Malignancies, and when given as a monotherapy of tremelimumab in Second- or Third-line Treatment of Japanese Subjects with Unresectable Pleural or Peritoneal Malignant Mesothelioma
Primary objectives Part A: To investigate the safety and tolerability of tremelimumab when given to Japanese patients with advanced solid malignancies and define the dose(s) for further clinical evaluation. Part B: To investigate the safety and tolerability of tremelimumab in combination with MEDI4736 when given to Japanese patients with advanced solid malignancies and to define the dose(s) for further clinical evaluation. Part C: To investigate the safety and tolerability of tremelimumab when given to Japanese patients with unresectable pleural or peritoneal malignant mesothelioma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
65
Tremelimumab administered intravenously
MEDI4736 administered intravenously.
Research Site
Bunkyō City, Japan
Research Site
Chūōku, Japan
Research Site
Hiroshima, Japan
Research Site
Nagoya, Japan
Adverse event
To investigate the safety and tolerability of tremelimumab and/ or MEDI4736 when given to Japanese patients
Time frame: From time of informed consent to 90 days after the last dose
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Research Site
Nishinomiya-shi, Japan
Research Site
Okayama, Japan
Research Site
Osaka, Japan
Research Site
Sapporo, Japan
Research Site
Sunto-gun, Japan
Research Site
Ube-shi, Japan
...and 1 more locations