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Japanese to English: A Phase III, Unblinded, Multicenter Study for the Use of Avelumab (MSB0010718C) as a Third-line Therapy in the Treatment of Inoperable, Relapsing or Metastatic Gastric or Gastroesophageal Junction Adenocarcinomas General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - Japanese 本治験は、北米、南米、アジア、オーストラリア、および欧州の約170の治験実施医療機関で世界的に実施される。
副次目的は次のとおり：
• 以下についてavelumab＋BSCと医師が選択する療法＋BSCを比較する。
• 独立レビュー委員会（IRC）評価に基づく無増悪生存期間（PFS）
• IRC評価に基づく客観的奏効率（ORR）
• European Quality of Life (EuroQOL) 5-dimensions and 5-levels questionnaire（EQ-5D-5L）、欧州がん研究・治療機構（EORTC）のQLQ-C30およびmodule QLQ-STO22を用いた被験者報告アウトカム／生活の質（QoL）
• avelumabの安全性および忍容性を評価する。
Translation - English This trial will be conducted worldwide in approximately 170 sites in North America, South America, Asia, Australia and Europe.
Enrollment of the first subject: 4th quarter of 2015
End of the clinical trial for the last subject: 3rd quarter of 2018
Objectives:
The primary objective is to demonstrate the superiority of avelumab + best supportive care (BSC) over the physician’s choice of treatment regime (chosen from a stipulated list of treatments) + BSC on the overall survival (OS).
The secondary objectives are as follows:
• To compare avelumab + BSC with physician’s choice of treatment regime + BSC in the following.
• Progression-free survival (PFS) based on the evaluation of independent review committee (IRC)
• Objective response rate (ORR) based on the evaluation of IRC
• Patient-reported outcome/ quality of life utilizing the European Quality of Life (EuroQOL) 5-dimensions and 5-levels questionnaire (EQ-5D-5L) and European Organization for Research and Treatment of Cancer (EORTC)’s QLQ-C30 as well as module QLQ-STO22.
• To evaluate the safety and tolerability of avelumab.
The exploratory objectives are as follows:
• To compare avelumab + BSC with physician’s choice of treatment regime + BSC with regards to the duration of response, based on IRC’s evaluation.
• To compare avelumab + BSC with physician’s choice of treatment regime + BSC with regards to the time to response, based on IRC’s evaluation.
• To evaluate tumor shrinkage from the baseline of targeted pathological changes at various time points, based on IRC’s evaluation.
• To evaluate the disease control rate (DCR).
• To evaluate programmed death ligand 1 (PD-L1) expression levels of tumor cells and cells of the tumor microenvironment (e.g., lymphocytes) as a predictive biomarker candidate, together with its relevance to specific clinical response parameters.
• To evaluate the clinical response parameters [Best overall response (BOR), DCR, PFS and OS] according to PD-L1 expression.
• To evaluate individual drug exposure from small sampling of pharmacokinetics (PK) samples and to carry out exposure-response analyses.
• To evaluate the exposure-response relationship (Exposure-safety and exposure-efficacy relationships) of avelumab with regards to specific safety and efficacy endpoints.
• To evaluate the immunogenicity of avelumab.
• To explore the mechanism of action of avelumab, molecular markers that maybe relevant to response/ resistance to avelumab which are found in peripheral blood and/ or tumor tissues, cellular markers as well as soluble markers (For example, gene expression profiles, microsatellite instability, tumor lymphocytes and also changes in cytokine levels)
Japanese to English: Clinical Trial Agreement General field: Medical Detailed field: Medical: Pharmaceuticals
Article 2 Party A and Party B shall comply with the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (hereinafter referred to as “Laws on Pharmaceuticals and Medical Devices,etc.”), the same Enforcement Order and Regulations, GCP Ordinance and notices pertaining to theGCP Ordinance (hereinafter collectively referred to as “GCP Ordinance, etc.”to conduct the Study.
2. Party A and Party B shall place the human rights and welfare of the subjects as the top priority and shall not engage in activities that may negatively affect the safety and privacy of the subjects when conducting the Study.
3. Party A shall comply with the study protocol of the previous article and conduct the Study in a prudent and proper manner.
4. Prior to the enrollment of the subject intothe Study, Party A shall have the Principal Investigator draft the explanatory materials and consent forms stipulated by the items in Article 51, Paragraph 1 and handing them over to the subject while fully explaining the details of the Study, etc., basedon said explanatory materials, after which obtain voluntary written consent for participation in the Study. After obtaining consent, a copy of the consent form shall be provided to the subject. In the event that obtaining consent from the subject is difficult, information is learned that will affect the subject's decision to participate or to continue participation in the Study, a non-therapeutic study is conducted, a life-saving study is carried during an emergency, or the subject is unable to read the consent form, etc., consent shall be obtained in a manner that is in accordance with the GCP Ordinance, etc.
5. Party A, the Principal Investigator and Party B must notify and report, as stipulated by the GCP Ordinance, in a timely and appropriate manner.
6. If continuing the Study will be difficult due to natural disasters or any unforeseen circumstances, Party A may consult Party B to terminate the Study or extending the study duration.
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