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Clinical Trials List

Protocol NumberEMR 100070-008

2015-10-01 - 2017-02-15

Phase III

Terminated5

Study ended1

ICD-10C16.0

Malignant neoplasm of cardia

ICD-10C16

Malignant neoplasm of stomach

ICD-9151.0

Malignant neoplasm of cardia of stomach

A Phase III open-label, multicenter trial of avelumab (MSB0010718C) as a third-line treatment of unresectable, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma

Trial Applicant

IQVIA RDS Taiwan Ltd.
Sponsor

Merck KGaA
Trial scale

Multi-Regional Multi-Center
Update

2025/08/20

Investigators and Locations

Principal Investigator Yee Chao 無

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

CRO

Principal Investigator 陳彥仰無

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Kun-Huei Yeh 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Principal Investigator Chia-Jui Yen 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Principal Investigator Chang-Fang Chiu 未分科

China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator Jen-Shi Chen 無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Principal Investigator Chang-Fang Chiu 無

China Medical University Hospital

Co-Principal Investigator

Che-Hung Lin 無
Li-Yuan Bai 無

Condition/Disease

unresectable, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma

Objectives

Primary objective The primary objective is to demonstrate superiority with regard to overall survival (OS) of avelumab plus best supportive care (BSC) versus physician’s choice (chosen from a pre-specified list of therapeutic options) plus BSC. Secondary objectives Secondary objectives are as follows:  To compare avelumab plus BSC versus physician’s choice plus BSC in regard to the following:  Progression-free survival (PFS) based on an Independent Review Committee (IRC) assessment  Objective response rate (ORR) based on IRC assessment  Subject-reported outcomes/quality of life (QoL) using the European Quality of Life (EuroQOL) 5-dimensions and 5-levels questionnaire (EQ-5D-5L), and the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and module QLQ-STO22.  To determine the safety and tolerability of avelumab.

Test Drug

Avelumab

Active Ingredient

Avelumab

Dosage Form

Injection

Dosage

Endpoints

Primary endpoints: The primary endpoint of the trial is OS, defined as the time (in months)
from randomization to the date of death, regardless of the actual cause of the subject’s death.
Secondary endpoints: The secondary endpoints include PFS according to RECIST v1.1 and
as adjudicated by the IRC, BOR as adjudicated by the IRC, subject-reported outcomes/QoL
(assessed by the EQ-5D-5L, EORTC QLQ-C30, and EORTC module QLQ-STO22
questionnaires) and safety endpoints (including AEs, physical examination findings, clinical
laboratory assessments, 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 slides (preferably 10) unstained tumor slides suitable for PD-L1 expression
assessment, and with histologically confirmed unresectable, recurrent, or metastatic,
adenocarcinoma of the stomach or the gastroesophageal junction and 2 prior courses of
systemic treatment for unresectable, recurrent, or metastatic gastric cancer. Subjects must have
progressed after the second line.
First-line therapy must consist of any of the following:
 Fluoropyrimidine-platinum-based doublet
 Fluoropyrimidine components can consist of S1, 5-fluorouracil, or capecitabine
 Platinum component can consist of either oxaliplatin or cisplatin
 Fluoropyrimidine-platinum-based triplets consisting of the addition of docetaxel to a
fluoropyrimidine-platinum-based doublet
 FOLFIRI, which consists of the administration of fluorouracil, leucovorin, and irinotecan
 Adjuvant or neo-adjuvant fluoropyrimidine-platinum-containing doublets will be
considered as a first-line if relapse occurs within 6 months after the last administration of
the platinum salt.
Second-line therapy is defined as any of the following:
 Another line of a platinum doublet or FOLFIRI if the disease has progressed more than
6 months after completion of the first-line combination therapy
 Ramucirumab (as a single agent or in combination)
 Docetaxel (as a single agent or in combination)
 Paclitaxel (as a single agent or in combination)
 Irinotecan (as a single agent or in combination)

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), brain
metastases (except those treated locally, have not been progressing at least 2 months after
completion of therapy, those with no steroid maintenance therapy required, and no ongoing
neurological symptoms related to brain localization of the disease), any history of anaphylaxis,
or uncontrolled asthma (that is, 3 or more features of partially controlled asthma) and persisting
toxicity related to prior therapy of Grade > 2 NCI-CTCAE v4.03 (except neuropathy and
alopecia).

The Estimated Number of Participants

Taiwan

15 participants
Global

330 participants