Clinical Trials List
2015-09-01 - 2018-12-31
Phase II
Terminated3
ICD-10C16
Malignant neoplasm of stomach
A Phase 1b/2 Study of MEDI4736 in Combination with Tremelimumab, MEDI4736 Monotherapy, and Tremelimumab Monotherapy in Subjects with Metastatic or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma
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Trial Applicant
Pharmaceutical Research Associates Taiwan Inc.
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Sponsor
MedImmune, LLC
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Rheun-Chuan Lee Division of Hematology & Oncology
- Chung-Pin Li Division of Hematology & Oncology
- Yi-Ping Hung Division of Hematology & Oncology
- Ming-Huang Chen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
2 Stop recruiting
Audit
None
Co-Principal Investigator
- Wen-Chi Chou Division of Hematology & Oncology
- Yung-Chia Kao Division of Hematology & Oncology
- Hung-Chih Hsu Division of Hematology & Oncology
- Wen-Chi Shen Division of Hematology & Oncology
- 候明模 Division of Hematology & Oncology
- Tsai-Sheng Yang Division of Hematology & Oncology
- Chia-Hsun Hsieh Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
7 Stop recruiting
Audit
None
Co-Principal Investigator
- Chiun Hsu Division of Hematology & Oncology
- TA-CHEN HUANG Division of Hematology & Oncology
- Chih-Hung Hsu Division of Hematology & Oncology
- Ann-Lii Cheng Division of Hematology & Oncology
- 葉伸輝 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Tremelimumab
Dosage Form
solution
Dosage
400 mg/vial
Endpoints
1. For Phase 1b: Safety of MEDI4736 in combination with tremelimumab as assessed by the presence of
adverse events (AEs), serious adverse events (SAEs), DLTs, laboratory parameters, vital signs, physical
examination, and electrocardiogram (ECG) results.
2. For Phase 2: Clinical activity of MEDI4736 in combination with tremelimumab, MEDI4736 monotherapy,
and tremelimumab monotherapy as determined by ORR and PFS-6 based on RECIST v1.1.
Secondary Endpoints
1. For Phase 1b: Clinical activity of MEDI4736 in combination with tremelimumab as determined by ORR,
DCR at 16 weeks (DCR-16w), DCR at 24 weeks (DCR-24w), and PFS-6.
2. For Phase 2: Safety of MEDI4736 in combination with tremelimumab, MEDI4736 monotherapy, and
tremelimumab monotherapy as assessed by the presence of AEs, SAEs, laboratory parameters, vital signs,
physical examination, and ECG results.
3. For Phase 2: Clinical activity of MEDI4736 in combination with tremelimumab, MEDI4736 monotherapy,
and tremelimumab monotherapy as determined by DCR-16w, DCR-24w, DoR, PFS, and PFS at 9 months
(PFS-9) based on RECIST v1.1, and OS and 1-year survival.
4. For Phase 2: PD-L1 expression and localization (by immunohistochemistry or immunofluorescence) within
the tumor microenvironment and how it correlates with clinical activity for MEDI4736 in combination
with tremelimumab, MEDI4736 monotherapy, and tremelimumab monotherapy.
Inclution Criteria
1. Male and female participants
2. 18 years and older
3. Histological or cytological confirmation of metastatic or recurrent gastric or gastroesophageal junction adenocarcinoma
4. Participants must have received and have progressed, or are refractory to standard regimens
5. Participants must have at least one lesion amenable to biospy
Exclusion Criteria
1. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
2. Previous immunotherapy
3. Concurrent or prior use of immunosuppressive medication with 14 days
4. Active or prior documented autoimmune or inflammatory disease within 3 years with some exceptions
The Estimated Number of Participants
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Taiwan
35 participants
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Global
160 participants
