Clinical Trials List
2016-05-01 - 2018-09-30
Phase III
Terminated9
ICD-10C16.0
Malignant neoplasm of cardia
ICD-10C16
Malignant neoplasm of stomach
A Phase III open-label, multicenter trial of maintenance therapy with avelumab (MSB0010718C) versus continuation of first-line chemotherapy in subjects with unresectable, locally advanced or metastatic, adenocarcinoma of the stomach, or of the gastro esophageal junction
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
Merck KGaA
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Yan-Shen Shan 無
- Nai-Jung Chiang 未分科
- Shang-Yin Wu 無
- 姜乃榕 無
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
1 Stop recruiting
Audit
CRO
Co-Principal Investigator
- Huey-En Tzeng 無
- 鄭紹斌 無
- 楊陽生 無
- 簡榮生 無
- TENG-YU LEE 無
- 吳誠中 無
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Yu-Li Su 無
- Meng-Jer Hsieh 無
- 陳彥豪 無
- 饒坤銘 無
- Shau-Hsuan Li 無
- 劉建廷 無
- Tai-Jan Chiu 無
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
Audit
None
Taiwan National PI
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
6 Stop recruiting
Audit
None
Co-Principal Investigator
- Chiun Hsu 無
- Ying-Chun Shen 無
- Hsiang-Fong Kao 無
- 林育麟 無
- SUNG-HSIN KUO 無
- 張端瑩 無
- 陳國興 無
- Chih-Hung Hsu 無
- 林宗哲 無
- 呂理駿 無
- JHE-CYUAN GUO 無
- Ann-Lii Cheng 無
- Chia-Chi Lin 無
- TA-CHEN HUANG 無
- Wei-Wu Chen 無
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
The primary endpoints of the trial are:
OS, defined as the time (in months) from randomization to the date of death, regardless
of the actual cause of the subject’s death; or
PFS, defined as the time (in months) from randomization to the date of the first
documentation of disease progression (per RECIST v1.1 and as adjudicated by the IRC)
or death due to any cause (whichever occurs first).
Secondary endpoints:
The key secondary endpoint is Best Overall Response (BOR) according to RECIST v1.1 as
adjudicated by the IRC. Other secondary endpoints include subject-reported outcomes/quality
of life (assessed by the EQ-5D-5L, EORTC QLQ-C30, and EORTC module QLQ-STO22
questionnaires).
Exploratory endpoints:
Tumor shrinkage in target lesions at each time point from baseline
PD-L1 expression levels in tumor cells and cells of the tumor microenvironment at baseline
with their relation to selected clinical response parameters
Molecular, cellular and soluble markers in peripheral blood and/or tumor tissue that may
be relevant to the mechanism of action of, or response/resistance to avelumab
Duration of response of avelumab
Time to response of avelumab
Population PK of avelumab and individual drug exposures based on sparse PK sampling
Exposure response (exposure safety and exposure efficacy) for avelumab with respect to
selected safety and efficacy endpoints
Immunogenicity of avelumab
Safety endpoints:
Safety endpoints include adverse events (AEs), assessed throughout the trial and evaluated
using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events
(CTCAE) v4.03, physical examinations, clinical laboratory assessments, concomitant
medications, vital signs, electrocardiogram parameters, and ECOG PS.
Inclution Criteria
Male or female subjects aged ≥ 18 years, with an ECOG PS of 0 to 1 at trial entry, with the
availability of a formalin-fixed, paraffin-embedded block containing tumor tissue or a
minimum of 7 (preferably 10) unstained tumor slides suitable for PD-L1 expression
assessment, at least 1 measurable tumor lesion, and with histologically confirmed unresectable,
locally advanced or metastatic, adenocarcinoma of the stomach or the GEJ.
Exclusion Criteria
Prior therapy with any antibody or drug targeting T-cell coregulatory proteins, concurrent
anticancer treatment, or immunosuppressive agents. Other exclusion criteria include severe
hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCI-CTCAE v4.03), any
history of anaphylaxis or uncontrolled asthma (that is, 3 or more features of partially controlled
asthma), persisting toxicity related to prior therapy of Grade ≥ 2 NCI-CTCAE v4.03 and prior
chemotherapy for unresectable locally advanced or metastatic adenocarcinoma of the stomach
or GEJ.
The Estimated Number of Participants
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Taiwan
39 participants
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Global
666 participants
