Esophageal Cancer Clinical Trial
A Phase 1b/2 Study of MEDI4736 With Tremelimumab, MEDI4736 or Tremelimumab Monotherapy in Gastric or GEJ Adenocarcinoma
Summary
This is a randomized, multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI4736 in combination with tremelimumab, MEDI4736 monotherapy or tremelimumab monotherapy in participants with metastatic or recurrent gastric or gastroesophageal junction adenocarcinoma.
Eligibility Criteria
Inclusion Criteria:
Male and female participants
18 years and older
Histological or cytological confirmation of metastatic or recurrent gastric or gastroesophageal junction adenocarcinoma
Participants must have received and have progressed, or are refractory to standard regimens
Participants must have at least one lesion amenable to biospy
Exclusion Criteria:
Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
Previous immunotherapy
Concurrent or prior use of immunosuppressive medication with 14 days
Active or prior documented autoimmune or inflammatory disease within 3 years with some exceptions
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There are 28 Locations for this study
Los Angeles California, 90033, United States
Santa Monica California, 90404, United States
New Haven Connecticut, 06520, United States
Tampa Florida, 33612, United States
Chicago Illinois, 60637, United States
Baltimore Maryland, 21231, United States
New York New York, 10032, United States
New York New York, 10065, United States
New York New York, 10116, United States
Cleveland Ohio, 44106, United States
Portland Oregon, 97213, United States
Philadelphia Pennsylvania, 19111, United States
Greenville South Carolina, 29605, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
Montreal Quebec, H4A 3, Canada
Kawasaki-shi , 216-8, Japan
Koto-ku , 135-8, Japan
Osaka-shi , 541-8, Japan
Seongnam-si , 13620, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06351, Korea, Republic of
Singapore , 11908, Singapore
Singapore , 30843, Singapore
Taipei , 100, Taiwan
Taipei , 11217, Taiwan
Taoyuan , 333, Taiwan
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