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切除不能な局所進行性、切除不能な再発性、または転移性食道癌の参加者における一次治療としてのパクリタキセルおよびシスプラチンと比較したパクリタキセルおよびシスプラチンとの併用におけるアテゾリズマブとチラゴルマブの研究 (SKYSCRAPER-08)

2026年8月4日 更新者：Hoffmann-La Roche

切除不能な局所進行性、切除不能な再発性、または転移性食道扁平上皮癌患者における第一選択治療としてのパクリタキセルおよびシスプラチンと比較した、アテゾリズマブとパクリタキセルおよびシスプラチンの併用によるアテゾリズマブとチラゴルマブの無作為化二重盲検プラセボ対照試験

この研究の目的は、アテゾリズマブとパクリタキセルおよびシスプラチン（PC）を組み合わせたアテゾリズマブとチラゴルマブの併用の有効性と安全性を、切除不能な局所進行性および切除不能な再発の参加者の第一選択治療として、アテゾリズマブと一致するプラセボとチラゴルマブと一致するプラセボと PC を比較して評価することです。 、または転移性食道癌（EC）。 参加者は 1:1 の比率で無作為化され、導入段階で次のいずれかの治療レジメンを受けます。

アーム A: アテゾリズマブ + ティラゴルマブおよび PC アーム B: アテゾリズマブ プラセボ + ティラゴルマブ プラセボおよび PC 導入段階の後、参加者は、アテゾリズマブ + チラゴルマブ (アーム A) またはアテゾリズマブ マッチング プラセボ + チラゴルマブ マッチング プラセボ (アーム B) のいずれかによる維持療法を継続します。

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

461

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • タイ
      • Bangkok、タイ、10700
        • Siriraj Hospital
      • Bangkok、タイ、10400
        • Rajavithi Hospital
      • Bangkok、タイ、10330
        • Chulalongkorn Hospital
      • Bangkok、タイ、10400
        • Ramathibodi Hospital
      • Songkhla、タイ、90110
        • Songklanagarind Hospital
  • 中国
      • Anhui、中国、230001
        • Anhui Provincial Hospital
      • Anyang、中国、455000
        • Anyang Tumor Hosptial
      • Beijing、中国
        • Beijing Luhe Hospital Capital Medical University
      • Changchun、中国、130021
        • The First Hospital of Jilin University
      • Changchun、中国、132013
        • Jilin cancer hospital
      • Changsha、中国、410013
        • Hunan Cancer Hospital
      • Chengde、中国、067020
        • Affiliated Hospital of Chengde Medical University
      • Chengdu、中国、610041
        • West China Hospital, Sichuan University
      • Chengdu、中国、610041
        • Sichuan Provincial Cancer Hospital
      • Chongqing、中国、404000
        • Chongqing Sanxia Central Hospital
      • Foshan、中国、510000
        • The First People's Hospital of Foshan
      • Fuzhou、中国、350014
        • Fujian Cancer Hospital
      • Fuzhou、中国
        • Fujian Provincial Hospital
      • Guangdong Province Guangzhou City、中国、510515
        • Southern medical university Nanfang hospital
      • Hangzhou、中国、310022
        • Zhejiang Cancer Hospital
      • Harbin、中国、150081
        • Harbin Medical University Cancer Hospital
      • Hefei、中国、230601
        • The Second Affiliated Hospital of Anhui Medical University
      • Hefei、中国、12345
        • Anhui Province Cancer Hospital
      • Huai'an、中国
        • Huai'an first people's hospital
      • Huai'an、中国
        • The Second People's Hospital of Huai'an
      • Jining、中国
        • Affiliated Hopsital of Jining Medical University
      • Lanzhou、中国、730000
        • Gansu Province People Hospital
      • Lianyungang、中国、222002
        • The First People's Hospital of Lian Yun Gang
      • Linyi、中国、276034
        • Linyishi Cancer Hospital
      • Luoyang、中国、471003
        • The First Affiliated Hospital to Henan University of Science and Technology
      • Nanjing、中国、211100
        • Jiangsu Cancer Hospital
      • Nanjing、中国、210029
        • Jiangsu Province Hospital of Chinese Medicine
      • Nantong、中国、226361
        • Nan Tong Tumor Hospital
      • Shanghai、中国、200000
        • Shanghai Chest Hospital
      • Shanghai、中国、200032
        • Zhongshan Hospital Fudan University
      • Shanghai、中国、200120
        • Fudan University Shanghai Cancer Center
      • Shantou、中国、515041
        • Cancer Hospital of Shantou University Medical College
      • Shengyang、中国、110042
        • Liaoning Provincial Cancer Hospital
      • Suining、中国、629000
        • Suining Central Hospital
      • Tianjin、中国、300060
        • Tianjin Cancer Hospital
      • Weifang、中国
        • Weifang People's Hospital
      • Wuhan、中国、430079
        • Hubei Cancer Hospital
      • Wuhan、中国、430022
        • Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
      • Wuxi、中国、214122
        • Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital )
      • Xi'an、中国、710061
        • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
      • Xi'an、中国、710038
        • The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
      • Xiamen、中国、361003
        • The First Affiliated Hospital of Xiamen University
      • Xiamen、中国、361004
        • Zhongshan Hospital Xiamen University
      • Xiangyang、中国
        • Xiangyang Central Hospital
      • Xinxiang、中国
        • The First Affiliated Hospital of Xinxiang Medical University
      • Xuzhou、中国
        • Xuzhou Central Hospital
      • Yangzhou、中国、225001
        • Northern Jangsu People's Hospital
      • Zhengzhou、中国、450008
        • Henan Cancer Hospital
      • Zhengzhou、中国、450052
        • The First Affiliated Hospital of Zhengzhou University
  • 台湾
      • Kaohisung、台湾
        • Chang Gung Medical Foundation - Kaohsiung
      • Tainan、台湾、00704
        • National Cheng Kung University Hospital
      • Taipei、台湾、112201
        • Taipei Veterans General Hospital
      • Zhongzheng Dist.、台湾、10048
        • National Taiwan University Hospital
  • 韓国
      • Daegu、韓国、41404
        • Kyungpook National University Chilgok Hospital
      • Goyang-si、韓国、10408
        • National Cancer Center
      • Seongnam-si、韓国、13605
        • Seoul National University Bundang Hospital
      • Seoul、韓国、05505
        • Asan Medical Center
      • Seoul、韓国、06351
        • Samsung Medical Center
      • Seoul、韓国、03722
        • Severance Hospital, Yonsei University Health System
      • Seoul、韓国、08308
        • Korea University Guro Hospital
  • 香港
      • Hong Kong、香港
        • Queen Mary Hospital
      • Shatin、香港
        • Prince of Wales Hosp

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

説明

主な採用基準:

  • 組織学的に確認されたEC
  • 切除不能な局所進行性、切除不能な再発性、または転移性疾患
  • 固形腫瘍バージョン 1.1 の応答評価基準 (RECIST v1.1) による測定可能な疾患
  • -東部共同腫瘍学グループ（ECOG）のパフォーマンスステータス0または1
  • -適切な血液学的および末端器官の機能
  • -女性の参加者は、妊娠を避け、治療期間中および最終投与後90日間は卵子提供を控えることをいとわない必要があります
  • -出産の可能性のあるパートナーを持つ男性参加者は、2つの避妊方法の使用にコミットする必要があり、研究期間中および最終投与後90日間精子を提供してはなりません

主な除外基準:

  • -試験治療開始前4週間以内のECに対する緩和放射線治療
  • -治療に適していない完全な食道閉塞の証拠
  • 症候性、未治療、または進行中の中枢神経系 (CNS) 転移
  • コントロールされていない腫瘍関連の痛み、コントロールされていない胸水、心嚢液、または繰り返しのドレナージ手順を必要とする腹水
  • -自己免疫疾患または免疫不全または軟髄膜疾患の活動性または病歴
  • -特発性肺線維症、器質化肺炎、薬剤性肺炎、または特発性肺炎の病歴、または活動性肺炎の証拠
  • -スクリーニング前の2年以内のEC以外の悪性腫瘍 転移または死亡のリスクが無視できる 期待される治癒結果で適切に治療された
  • -研究治療の開始前4週間以内の重度の感染症、または研究者の意見では、患者の安全に影響を与える可能性のある活動的な感染症
  • ヒト免疫不全ウイルス（HIV）の陽性検査結果
  • 活動性のB型肝炎またはC型肝炎
  • -CD137アゴニストまたは免疫チェックポイント遮断療法、抗CTLA-4、抗TIGIT、抗PD-1、および抗PD-L1治療抗体による以前の治療
  • -研究治療の開始前の治験療法による治療
  • 末梢静脈アクセス不良
  • -以前の同種幹細胞または固形臓器移植
  • 別の治療臨床試験への同時参加

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：アテゾリズマブ + ティラゴルマブ + PC
参加者は、研究中の各 21 日サイクルの 1 日目にアテゾリズマブとチラゴルマブを投与され、続いて各 21 日サイクルの 1 日目にパクリタキセルとシスプラチンが投与されます。これは、導入治療段階で、疾患の進行、臨床的利益の喪失、または許容できない毒性が生じるまで続きます。
薬：アテゾリズマブ
各 21 日サイクルの 1 日目に、3 週間ごと (Q3W) に静脈内 (IV) 注入によって投与される 1200 ミリグラム (mg) の固定用量のアテゾリズマブ。
他の名前：
  • テセントリク
薬：ティラゴルマブ
各 21 日サイクルの 1 日目に、Q3W ごとに IV 注入により 600 mg の固定用量で投与されるチラゴルマブ。
他の名前：
  • MTIG7192A
薬：パクリタキセル
パクリタキセル 175 mg/m^2 を 6 サイクルの各 21 日サイクルの 1 日目に IV 注入により投与。
薬：シスプラチン
シスプラチン 60-80 mg/m^2 を 6 サイクルの各 21 日サイクルの 1 日目に IV 注入により投与。
プラセボコンパレーター：プラセボ + PC
参加者は、研究中の各 21 日サイクルの 1 日目にアテゾリズマブ マッチング プラセボおよびチラゴルマブ マッチング プラセボを受け取り、続いて各 21 日サイクルの 1 日目にパクリタキセルおよびシスプラチンを受け取ります。導入治療段階。
薬：パクリタキセル
パクリタキセル 175 mg/m^2 を 6 サイクルの各 21 日サイクルの 1 日目に IV 注入により投与。
薬：シスプラチン
シスプラチン 60-80 mg/m^2 を 6 サイクルの各 21 日サイクルの 1 日目に IV 注入により投与。
薬：アテゾリズマブ マッチング プラセボ
各 21 日サイクルの 1 日目に Q3W に IV 注入によって投与されるアテゾリズマブ マッチング プラセボ。
薬：ティラゴルマブ マッチング プラセボ
各 21 日サイクルの 1 日目に Q3W で IV 注入により投与された Tiragolumab に一致するプラセボ。

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Independent Review Facility (IRF)-Assessed Progression-free Survival (PFS)
時間枠：From randomization to the first occurrence of PD or death from any cause, whichever occurred first (up to approximately 19 months)
PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause (whichever occurred first), as determined by an IRF according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 millimeters (mm) or unequivocal progression of existing non-target lesions. Kaplan-Meier (KM) method was used to estimate median PFS.
From randomization to the first occurrence of PD or death from any cause, whichever occurred first (up to approximately 19 months)
Overall Survival (OS)
時間枠：From randomization to death from any cause (up to approximately 27.5 months)
OS was defined as the time from randomization to death from any cause. K-M method was used to estimate median OS.
From randomization to death from any cause (up to approximately 27.5 months)

二次結果の測定

結果測定
メジャーの説明
時間枠
Investigator-assessed PFS
時間枠：From randomization to the first occurrence of PD or death from any cause, whichever occurs first (up to approximately 19 months)
PFS was defined as the time from randomization to the first occurrence of PD or death from any cause (whichever occurred first), as determined by the investigator according to RECIST v1.1. PD was defined at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median PFS.
From randomization to the first occurrence of PD or death from any cause, whichever occurs first (up to approximately 19 months)
IRF-assessed Confirmed Objective Response Rate (ORR)
時間枠：Up to approximately 19 months
IRF-assessed confirmed ORR was defined as the percentage of participants with an objective response (OR), characterized by a complete response (CR) or partial response (PR) on 2 consecutive occasions ≥ 4 weeks apart, as determined by an IRF according to RECIST v1.1. CR was defined as disappearance of all target lesions. & normalization of tumor marker level. Additionally, any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
Up to approximately 19 months
Investigator-assessed Confirmed ORR
時間枠：Up to approximately 19 months
Investigator-assessed confirmed ORR was defined as the percentage of participants with an OR, characterized by a CR or a PR on 2 consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target lesions. & normalization of tumor marker level. Additionally, any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
Up to approximately 19 months
IRF-assessed Duration of Objective Response (DOR)
時間枠：From the first occurrence of a of a confirmed OR to PD or death from any cause, whichever occurred first (up to approximately 19 months)
DOR was defined as the time from the first occurrence of a confirmed OR to PD or death from any cause (whichever occurred first), as determined by an IRF according to RECIST v1.1. OR was defined as either a CR or a PR on 2 consecutive occasions ≥ 4 weeks apart. CR was defined as disappearance of all target lesions. & normalization of tumor marker level. Additionally, any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median DOR.
From the first occurrence of a of a confirmed OR to PD or death from any cause, whichever occurred first (up to approximately 19 months)
Investigator-assessed DOR
時間枠：From the first occurrence of a of a confirmed OR to PD or death from any cause, whichever occurred first (up to approximately 19 months)
DOR was defined as the time from the first occurrence of a confirmed OR to PD or death from any cause (whichever occurred first), as determined by an IRF according to RECIST v1.1. OR was defined as either a CR or a PR on 2 consecutive occasions ≥ 4 weeks apart. CR was defined as disappearance of all target lesions. & normalization of tumor marker level. Additionally, any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median DOR.
From the first occurrence of a of a confirmed OR to PD or death from any cause, whichever occurred first (up to approximately 19 months)
Time to Confirmed Deterioration (TTCD) in Participant-reported Physical Functioning, as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)
時間枠：Up to approximately 27 months
Clinically meaningful changes in physical functioning as measured by the EORTC QLQ-C30. EORTC QLQ-C30 is a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), global health status/quality of life (GHS/QoL), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) within the previous week. Physical functioning was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better functioning. Participants were considered "Worsened" if their baseline score decreased by ≥10 points. K-M method was used to estimate median TTCD.
Up to approximately 27 months
TTCD in Participant-reported Role Functioning (RF), as Measured by EORTC QLQ-C30
時間枠：Up to approximately 27 months
Clinically meaningful changes in role functioning as measured by the EORTC QLQ-C30. EORTC QLQ-C30 is a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) within the previous week. Role functioning was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better functioning. Participants were considered "Worsened" if their baseline score decreased by ≥10 points. K-M method was used to estimate median TTCD.
Up to approximately 27 months
TTCD in Participant-Reported GHS/QoL, as Measured by EORTC QLQ-C30
時間枠：Up to approximately 27 months
Clinically meaningful changes in GHS/QoL as measured by the EORTC QLQ-C30. EORTC QLQ-C30 is a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) within the previous week. GHS and QoL items were scored on a 7-point scale, with scores ranging from 1=Very poor to 7=Excellent. Scores were linearly transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better GHS/QoL. Participants were considered "Worsened" if their baseline score decreased by ≥10 points. K-M method was used to estimate median TTCD.
Up to approximately 27 months
TTCD in Participant-reported Dysphagia, as Measured by European Organisation for Research and Treatment of Cancer Quality-of-life Esophageal Cancer, Module 18 Questionnaire (EORTC QLQ-OES18)
時間枠：Up to approximately 27 months
Clinically meaningful changes in dysphagia as measured by the EORTC QLQ-OES18. EORTC QLQ-OES18 is a modular supplement to the EORTC QLQ-C30 questionnaire for use in participants with esophageal cancer. EORTC QLQ-OES18 consists of 4 multiple-item scale (dysphagia, eating, reflux, and pain) and 6 single items (trouble swallowing saliva, choked when swallowing, dry mouth, trouble with taste, trouble with coughing, and trouble talking) with a recall period of the previous week. Each symptom item was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to a range of 0 to 100, with higher transformed scores (i.e. closer to 100) reflecting worse symptoms. Participants were considered "Worsened" if their baseline score increased by ≥ 10 points. K-M method was used to estimate median TTCD.
Up to approximately 27 months
Number of Participants With Adverse Events (AEs)
時間枠：Up to approximately 49.6 months
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product, and which does not necessarily have a causal relationship with the treatment. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Up to approximately 49.6 months
Number of Participants With Cytokine-release Syndrome (CRS), With Severity Determined by the American Society for Transplantation and Cell Therapy (ASTCT) Consensus Grading Scale
時間枠：Up to approximately 49.6 months
CRS was defined as supraphysiologic response following administration of any immune therapy that results in activation/engagement of endogenous or infused T cells and/or other immune effector cells. Symptoms may be progressive, including fever at onset, and may also include hypotension, capillary leak (hypoxia), and end-organ dysfunction. Severity of CRS was determined per ASTCT Consensus Grading Criteria, which categorizes CRS into 5 grades: Grade 1: fever (≥38◦Celsius), with/without constitutional symptoms, in absence of hypotension & hypoxia; Grade 2: fever with hypotension not requiring vasopressors and/or hypoxia requiring low-flow oxygen; Grade 3: fever with hypotension requiring one vasopressor, with/without vasopressin, and/or hypoxia requiring high-flow oxygen; Grade 4: fever accompanied by hypotension requiring multiple vasopressors (excluding vasopressin) and/or hypoxia requiring positive-pressure ventilation; Grade 5: death due to CRS.
Up to approximately 49.6 months
Minimum Serum Concentration (Cmin) of Tiragolumab
時間枠：Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12, and 16 (1 Cycle=21 days)
Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12, and 16 (1 Cycle=21 days)
Maximum Serum Concentration (Cmax) of Tiragolumab
時間枠：30 minutes post-dose on Day 1 of Cycle 1 (1 Cycle=21 days)
30 minutes post-dose on Day 1 of Cycle 1 (1 Cycle=21 days)
Cmin of Atezolizumab
時間枠：Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12, and 16 (1 Cycle=21 days)
Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12, and 16 (1 Cycle=21 days)
Cmax of Atezolizumab
時間枠：30 minutes post-dose on Day 1 of Cycle 1 (1 Cycle=21 days)
30 minutes post-dose on Day 1 of Cycle 1 (1 Cycle=21 days)
Number of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab
時間枠：Up to approximately 27.5 months
Participants were considered to be ADA positive if they were ADA negative at baseline but developed an ADA response following tiragolumab administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 0.60 titer unit (t.u.) greater than the baseline titer result (treatment-enhanced ADA response). Participants with a positive post-baseline sample have been reported here.
Up to approximately 27.5 months
Number of Participants With ADAs to Atezolizumab
時間枠：Up to approximately 27.5 months
Participants were considered to be ADA positive if they were ADA negative at baseline but developed an ADA response following atezolizumab administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 0.60 t.u. greater than the baseline titer result (treatment-enhanced ADA response). Participants with a positive post-baseline sample have been reported here.
Up to approximately 27.5 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Hoffmann-La Roche

捜査官

  • スタディディレクター：Clinical Trials、Hoffmann-La Roche

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2020年10月30日

一次修了 (実際)

2023年2月13日

研究の完了 (実際)

2025年8月28日

試験登録日

最初に提出

2020年9月3日

QC基準を満たした最初の提出物

2020年9月3日

最初の投稿 (実際)

2020年9月7日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月27日

QC基準を満たした最後の更新が送信されました

2026年8月4日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • YO42138

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

有資格の研究者は、臨床研究データ要求プラットフォーム (www.vivli.org) を通じて、個々の患者レベルのデータへのアクセスを要求できます。 適格な研究に関するロシュの基準の詳細については、こちら (https://vivli.org/ourmember/roche/) をご覧ください。 臨床情報の共有に関するロシュのグローバル ポリシーおよび関連する臨床研究文書へのアクセスを要求する方法の詳細については、こちら (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm) を参照してください。

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

はい

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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