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局所進行性または転移性尿路上皮がんにおける治療法としてのアベルマブのさまざまな組み合わせの安全性と有効性に関する研究 (JAVELIN Bladder Medley)

2026年8月10日 更新者：EMD Serono Research & Development Institute, Inc.

第 II 相、多施設、無作為化、非盲検、平行アーム、アンブレラ試験、一次治療で進行しなかった局所進行性または転移性尿路上皮がんの参加者における維持療法として、他の抗腫瘍薬と組み合わせたアベルマブ (MSB0010718C) (MSB0010718C) -化学療法（JAVELIN Bladder Medley）を含む

この研究の目的は、膀胱がん患者の維持療法として、アベルマブを他の抗腫瘍薬と併用した場合の安全性と有効性を評価することです。

調査の概要

状態

積極的、募集していない

条件

介入・治療

研究の種類

介入

入学 (実際)

256

段階

  • フェーズ2

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

  • アメリカ
    • Idaho
      • Coeur d'Alene、Idaho、アメリカ、83814
        • Beacon Cancer Care
    • Kansas
      • Kansas City、Kansas、アメリカ、66205
        • University of Kansas Medical Center Research Institute, Inc. - 3901 Rainbow (MAIN)
    • Maryland
      • Baltimore、Maryland、アメリカ、21287
        • The Johns Hopkins Hospital
      • Baltimore、Maryland、アメリカ、21287-7049
        • Johns Hopkins University
    • Missouri
      • Kansas City、Missouri、アメリカ、66204
        • AMR Kansas City, Formerly Center for Pharmaceutical Research, an AMR company - Kansas City, MO at St. Joseph Medical Center
    • Washington
      • Seattle、Washington、アメリカ、98109
        • Seattle Cancer Care Alliance
      • Tacoma、Washington、アメリカ、98405
        • Multicare Health System Tacoma General Hospital
    • Wisconsin
      • Madison、Wisconsin、アメリカ、53706
        • University of Wisconsin Cancer Center
  • イギリス
      • Manchester、イギリス
        • The Christie Hospital - Dept of Oncology
      • Preston、イギリス
        • Royal Preston Hospital - Rosemere Cancer Centre
    • Greater London
      • London、Greater London、イギリス、0024514
        • Barts Hospital - Dept of Medical Oncology
  • イタリア
      • Bologna、イタリア
        • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS - Oncologia Medica
      • Florence、イタリア
        • Azienda Ospedaliera Universitaria Careggi - S.O.D. di Oncologia Medica
      • Forlì、イタリア
        • IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST - Oncologia
      • Milan、イタリア
        • Ospedale San Raffaele - U.O. di Oncologia Medica
      • Milan、イタリア
        • Fondazione IRCCS Istituto Nazionale dei Tumori - S.S. Oncologia Medica Genitourinaria
      • Misterbianco、イタリア
        • Humanitas Istituto Clinico Catanese - Oncologia Medica
      • Naples、イタリア
        • Istituto Nazionale Tumori Fondazione G. Pascale - Oncologia Medica A
      • Naples、イタリア
        • Istituto Nazionale Tumori Regina Elena IRCCS - Urologia
      • Padova、イタリア
        • IOV - Istituto Oncologico Veneto IRCCS - U.O. Oncologia Medica 1
      • Pisa、イタリア
        • Azienda Ospedaliero Universitaria Pisana - U.O. Oncologia
      • Ravenna、イタリア
        • Ospedale Santa Maria Delle Croci
      • Rome、イタリア
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
      • San Giovanni Rotondo、イタリア
        • IRCCS Ospedale Casa Sollievo della Sofferenza - Dipartimento di Oncologia Medica
      • Terni、イタリア
        • Azienda Ospedaliera S. Maria Di Terni - S.C. Oncologia Medica
  • オーストラリア
      • Bedford Park、オーストラリア
        • Flinders Medical Centre
      • Footscray、オーストラリア
        • Sunshine Hospital - PARENT
      • Kurralta Park、オーストラリア
        • Ashford Cancer Centre Research
      • Liverpool、オーストラリア
        • Liverpool Hospital - PARENT
      • Newcastle、オーストラリア
        • Calvary Mater Newcastle - PARENT
      • Southport、オーストラリア
        • Tasman Oncology Research Ltd - Oncology
      • Sydney、オーストラリア
        • Macquarie University Hospital - PARENT
      • Westmead、オーストラリア
        • The Kinghorn Can Cen
  • カナダ
      • Brampton、カナダ
        • William Osler Health System - Brampton Civic Hospital
      • Greenfield Park、カナダ
        • CISSS de la Monteregie-Centre - Hospital Charles Le Moyne
      • Montreal、カナダ
        • CHUM Centre de Recherche
      • Ottawa、カナダ
        • The Ottawa Hospital Cancer Centre
  • ギリシャ
      • Athens、ギリシャ
        • General Hospital of Athens "Alexandra"
      • Athens、ギリシャ
        • University General Hospital "Attikon"
      • Athens、ギリシャ
        • Athens Medical Center
      • Thessaloniki、ギリシャ
        • Euromedica General Clinic of Thessaloniki
  • スペイン
      • Badajoz、スペイン
        • Hospital Infanta Cristina - Unidad de Fase I
      • Barcelona、スペイン
        • Hospital del Mar - Servicio de Oncologia
      • Barcelona、スペイン
        • Hospital de la Santa Creu i Sant Pau - Dept of Oncology
      • Barcelona、スペイン
        • Hospital Clinic de Barcelona - Servicio de Oncologia
      • Barcelona、スペイン
        • Hospital Universitario Virgen del Rocio - Oncology Service
      • Córdoba、スペイン
        • Hospital Universitario Reina Sofia - Dept of Oncology
      • Elche、スペイン
        • Hospital General Universitario de Elche - Servicio de Oncologia
      • Lugo、スペイン
        • Hospital Universitario Lucus Augusti - Oncology
      • Madrid、スペイン
        • Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica
      • Manresa、スペイン
        • ALTHAIA, Xarxa assistencial Universitaria de Manresa - Oncology Dept
  • ドイツ
      • Essen、ドイツ
        • Universitaetsklinikum Essen - Westdeutsches Tumorzentrum
      • Frankfurt、ドイツ
        • Universitaetsklinikum Frankfurt Goethe-Universitaet - Urologie und Kinderurologie2
      • Halle、ドイツ
        • Universitaetsklinikum Wuerzburg - Klinik u. Poliklinik f. Urologie u. Kinderurologie
      • Mönchengladbach、ドイツ
        • Kliniken Maria Hilf GmbH - Klinik fuer Urologie
      • Münster、ドイツ
        • Universitaetsklinikum Muenster - Klinik und Poliklinik fuer Urologie
      • Tübingen、ドイツ
        • Universitaetsklinikum Tuebingen - Klinik fuer Urologie
    • North Rhine-Westphalia
      • Muenchen、North Rhine-Westphalia、ドイツ、41063
        • Kliniken Maria Hilf GmbH - Klinik fuer Urologie
    • Saxony-Anhalt
      • Halle、Saxony-Anhalt、ドイツ、0044384
        • Universitaetsklinikum Halle (Saale) - Universitaetsklinik und Poliklinik fuer Urologie
  • フランス
      • Angers、フランス
        • ICO - Site Paul Papin - service d'oncologie medicale
      • Bordeaux、フランス
        • Institut Bergonié - Service d'Oncologie Médicale
      • Caen、フランス
        • Centre François Baclesse - Pathologies Gynecologiques
      • Créteil、フランス
        • Hôpital Henri Mondor - Service d'Oncologie Médicale
      • Le Mans、フランス
        • Clinique Victor Hugo - Centre Jean Bernard - Service d'Oncologie Médical
      • Lyon、フランス
        • Centre Leon Berard - Service d'Oncologie Medicale
      • Marseille、フランス
        • Hôpital de la Timone - service d'urologie
      • Nîmes、フランス
        • Hopital Caremeau - Service Hématologie Clinique/Oncologie Médicale
      • Paris、フランス
        • Hôpital Cochin - Hematologie et Oncologie Médicale
      • Poitiers、フランス
        • CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale
      • Rennes、フランス
        • CRLCC Eugene Marquis - Service d'Oncologie médicale
      • Saint-Herblain、フランス
        • ICO - Site René Gauducheau - Service d'Oncologie medicale
      • Strasbourg、フランス
        • Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale
      • Strasbourg、フランス
        • Clinique Sainte-Anne - Service d'Oncologie Médicale
    • Hauts De Seine
      • Suresnes、Hauts De Seine、フランス、92151
        • Hôpital Foch - Service d'Oncologie Médicale
  • ベルギー
      • Antwerp、ベルギー
        • ZNA Middelheim - Middelheim - account 2
      • Brasschaat、ベルギー
        • AZ Klina - PARENT
      • Brussels、ベルギー
        • Institut Jules Bordet - Medical Oncology
      • Ghent、ベルギー
        • Universitair Ziekenhuis Gent - Medical Oncology
      • Kortrijk、ベルギー
        • AZ Groeninge - Campus Kennedylaan - account 2
      • Libramont、ベルギー
        • Centre Hospitalier de l'Ardenne - PARENT
      • Liège、ベルギー
        • CHU de Liège - PARENT
      • Wuerzburg、ベルギー
        • Universitaetsklinikum Wuerzburg - Klinik u. Poliklinik f. Urologie u. Kinderurologie
  • 台湾
      • Kaohsiung City、台湾
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Kaohsiung City、台湾
        • Kaohsiung Chang Gung Memorial Hospital
      • Taichung、台湾
        • China Medical University Hospital
      • Tainan、台湾
        • Chi Mei Hospital, Liouying
      • Taipei、台湾
        • National Taiwan University Hospital
      • Taipei、台湾
        • Taipei Veterans General Hospital
      • Taoyuan、台湾
        • Chang Gung Memorial Hospital,Linkou
  • 韓国
      • Daejeon、韓国
        • Chungnam National University Hospital - Department of Internal Medicine (Rheumatology)
      • Gyeonggi-do、韓国
        • National Cancer Center
      • Seongnam-si、韓国
        • Seoul National University Bundang Hospital
      • Seoul、韓国
        • Asan Medical Center
      • Seoul、韓国
        • Samsung Medical Center
      • Seoul、韓国
        • Seoul National University Hospital
      • Seoul、韓国
        • Severance Hospital, Yonsei University Health System
      • Seoul、韓国
        • The Catholic University of Korea, Seoul St. Mary's Hospital

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

包含基準:

  • -組織学的に確認された切除不能な局所進行性または転移性尿路上皮がんの参加者。 移行細胞および移行細胞/非移行細胞混合の両方の組織型が許可されますが、移行細胞癌が優勢な組織型でなければなりません
  • 参加者は、一次化学療法の開始時に、ステージ IIIA/IIIB と N1-N3、またはステージ IV の疾患を記録しています (米国がん合同委員会/国際がん制御腫瘍節転移システム第 8 版による)。
  • -一次化学療法の最後の投与は、本研究の無作為化の前に、4週間以上、10週間以内に受けなければなりません
  • 推定余命は少なくとも 3 か月
  • -1L化学療法の4〜6サイクルの完了後、RECIST v1.1ガイドラインに従って進行性疾患のない参加者。 この基準に基づく適格性は、化学療法前および化学療法後の放射線評価（CT / MRIスキャン）の治験責任医師のレビューによって決定されます。
  • -Eastern Cooperative Oncology Group (ECOG) のパフォーマンス ステータス (PS) 0 または 1
  • -プロトコルで定義されている適切な血液学的、肝臓、および腎機能
  • 他のプロトコルで定義された包含基準が適用される可能性があります

除外基準:

  • -インターロイキン-2（IL-2）、IL-15、インターフェロンアルファ（IFN-α）、または抗プログラム死受容体-1（PD-1）、抗プログラム死リガンド1（PD-L1）による以前の免疫療法を受けた参加者)、抗 PD-L2、抗 CD137、または細胞傷害性 T 細胞リンパ球-4 (CTLA-4) 抗体 (イピリムマブを含む)、抗 TROP2、T 細胞共刺激または免疫チェックポイント経路を特異的に標的とするその他の抗体または薬剤、またはアベルマブと併用する治験薬。
  • -全身療法を必要とする無作為化の48時間前に活動性感染症のある参加者
  • -薬物またはその製剤中の成分を研究するための既知の以前または疑われる過敏症のある参加者
  • -以前のアジュバントまたはネオアジュバント全身療法を受けた参加者 無作為化から12か月以内
  • -研究治療の最初の投与から4週間以内にワクチン接種を受け、治験中の参加者は、不活化ワクチン（例えば、不活化インフルエンザワクチン）および地域の保健当局によって承認または認可された複製欠損コロナウイルスワクチンの投与を除いて禁止されています
  • 他のプロトコル定義の除外基準が適用される可能性があります

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：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Avelumab
Participants received intravenous infusion of Avelumab at a dose of 800 mg once every 2 weeks until unacceptable toxicity, withdraw consent or initiation of a new treatment.
薬：Avelumab
Participants received intravenous infusion of Avelumab at a dose of 800 mg once every 2 weeks until unacceptable toxicity, withdraw consent or initiation of a new treatment.
他の名前：
  • MSB0010718C
実験的：Avelumab + Sacituzumab Govitecan (SG)
Participants received intravenous infusion of Avelumab at a dose of 800 milligrams (mg) once every 2 weeks in combination with intravenous infusion of SG at dose of 10 milligrams per kilogram (mg/kg) of bodyweight once a week on Day 1 and 8 of each 21-daytreatment cycles until unacceptable toxicity, withdraw consent or initiation of a new treatment.
薬：Avelumab
Participants received intravenous infusion of Avelumab at a dose of 800 mg once every 2 weeks until unacceptable toxicity, withdraw consent or initiation of a new treatment.
他の名前：
  • MSB0010718C
薬：Sacituzumab Govitecan (SG)
Participants received intravenous infusion SG at dose of 10 mg/kg of bodyweight once a week on Day 1 and 8 of each 21-daytreatment cycles until unacceptable toxicity, withdraw consent or initiation of a new treatment.
他の名前：
  • IMMU-132
  • GS-0132
  • トロデルビー™
実験的：Avelumab + M6223
Participants received intravenous infusion of Avelumab at a dose of 800 mg once every 2 weeks in combination with intravenous infusion of M6223 at dose of 1600 mg once every 2 weeks until unacceptable toxicity, withdraw consent or initiation of a new treatment.
薬：Avelumab
Participants received intravenous infusion of Avelumab at a dose of 800 mg once every 2 weeks until unacceptable toxicity, withdraw consent or initiation of a new treatment.
他の名前：
  • MSB0010718C
薬：M6223
Participants intravenous infusion of M6223 at dose of 1600 mg once every 2 weeks until unacceptable toxicity, withdraw consent or initiation of a new treatment.
実験的：Group D: Avelumab + NKTR-255
Participants received intravenous infusion of Avelumab at a dose of 800 mg once every 2 weeks in combination with intravenous infusion of NKTR-255 at a dose of 3 micrograms per kilogram (mcg/kg) of body weight once every 4 weeks until unacceptable toxicity, withdraw consent or initiation of a new treatment.
薬：Avelumab
Participants received intravenous infusion of Avelumab at a dose of 800 mg once every 2 weeks until unacceptable toxicity, withdraw consent or initiation of a new treatment.
他の名前：
  • MSB0010718C
薬：NKTR-255
Participants intravenous infusion of NKTR-255 at a dose of 3 mcg/kg of body weight once every 4 weeks until unacceptable toxicity, withdraw consent or initiation of a new treatment.
他の：JB100 (NCT02603432)
As per the Clinical Study Protocol, the control group (avelumab alone) was extended by data from an external control, i.e. the JAVELIN Bladder 100 study (JB100) (NCT02603432). Participants received an intravenous infusion of 10 mg/kg of Avelumab along with best supportive care (BSC), on Day 1 and 15 of each 28 days treatment cycle, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. BSC was administered asper the treating physician. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anticancer therapy.
薬：JB100
As per the Clinical Study Protocol, the control group (avelumab alone) was extended by data from an external control, i.e. the JAVELIN Bladder 100 study (JB100) (NCT02603432). Participants received an intravenous infusion of 10 mg/kg of Avelumab along with best supportive care (BSC), on Day 1 and 15 of each 28 days treatment cycle, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. BSC was administered asper the treating physician. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anticancer therapy.

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
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator - Avelumab + Sacituzumab Govitecan Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])
時間枠：Time from date of randomization to first documentation of progressive disease (PD) or death, assessed up to 32 months and 12 days (current study) and 41 months (JB100 extended control group)
PFS:defined as time from date of randomization to first documentation of progressive disease (PD) or death, occurring within 2 scheduled tumor assessments after last evaluable assessment or randomization. PD:at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline/ appearance of 1/more new lesions. The propensity score (PS)-based weighted Kaplan-Meier estimated median PFS times. PS were used as weights to minimize impact of confounding factors on estimation of causal treatment effects. Each participant from randomized study was assigned a weight of 1, while participants from external control received a PS-based weight with sum of weights adding up to number of participants in randomized control arm. PFS Efficacy analysis was prespecified to use a pooled control population comprising the avelumab control arm and JB100 external control cohort; therefore, results are reported for combined control population.
Time from date of randomization to first documentation of progressive disease (PD) or death, assessed up to 32 months and 12 days (current study) and 41 months (JB100 extended control group)
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator - Avelumab + M6223 Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])
時間枠：Time from date of randomization to first documentation of progressive disease (PD) or death, assessed up to 32 months and 12 days (current study) and 41 months (JB100 extended control group)
PFS:defined as time from date of randomization to first documentation of progressive disease (PD) or death, occurring within 2 scheduled tumor assessments after last evaluable assessment or randomization. PD:at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline/ appearance of 1/more new lesions. The propensity score (PS)-based weighted Kaplan-Meier estimated median PFS times. PS were used as weights to minimize impact of confounding factors on estimation of causal treatment effects. Each participant from randomized study was assigned a weight of 1, while participants from external control received a PS-based weight with sum of weights adding up to number of participants in randomized control arm. PFS Efficacy analysis was prespecified to use a pooled control population comprising the avelumab control arm and JB100 external control cohort; therefore, results are reported for combined control population.
Time from date of randomization to first documentation of progressive disease (PD) or death, assessed up to 32 months and 12 days (current study) and 41 months (JB100 extended control group)
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator - Avelumab + NKTR-255 Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])
時間枠：Time from date of randomization to first documentation of progressive disease (PD) or death, assessed up to 32 months and 12 days (current study) and 41 months (JB100 extended control group)
PFS:defined as time from date of randomization to first documentation of progressive disease (PD) or death, occurring within 2 scheduled tumor assessments after last evaluable assessment or randomization. PD:at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline/ appearance of 1/more new lesions. The propensity score (PS)-based weighted Kaplan-Meier estimated median PFS times. PS were used as weights to minimize impact of confounding factors on estimation of causal treatment effects. Each participant from randomized study was assigned a weight of 1, while participants from external control received a PS-based weight with sum of weights adding up to number of participants in randomized control arm. PFS Efficacy analysis was prespecified to use a pooled control population comprising the avelumab control arm and JB100 external control cohort; therefore, results are reported for combined control population.
Time from date of randomization to first documentation of progressive disease (PD) or death, assessed up to 32 months and 12 days (current study) and 41 months (JB100 extended control group)
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events, and AEs of Special Interest (AESIs)
時間枠：Up to 32 months and 12 days (Current study) and 61 months and 11 days (JB100 extended control group)
Adverse Event (AE): any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE: AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as events with onset date or worsening during the on-treatment period, defined as the time from the first dose of study intervention administration days to the last administration day + 30 days, or the start day of subsequent anticancer therapy - 1 day, whichever occurred first. TEAEs included serious AEs and non- serous AEs. AESIs included Infusion-related reactions (IRRs), Immune-related AEs (irAEs), Thromboembolic events, Cytokine release syndrome, QT interval prolongation.
Up to 32 months and 12 days (Current study) and 61 months and 11 days (JB100 extended control group)

二次結果の測定

結果測定
メジャーの説明
時間枠
Overall Survival (OS) -Avelumab + Sacituzumab Govitecan Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])
時間枠：Time from date of randomization to death, assessed up to 32 months and 12 days (current study) and 41 months (JB100 extended control group)
OS: time from date of randomization to death. OS was analyzed by using PS-based weighted product-limit (Kaplan-Meier) estimates. PS were used as weights to minimize the impact of confounding factors on the estimation of causal treatment effects. Each participant from randomized study was assigned a weight of 1, while participants from external control received a PS-based weight with the sum of weights adding up to number of participants in randomized control arm. Pre-chosen baseline covariates with possible impact on OS outcome was used to calculate the preference score, i.e., a prevalence adjusted PS defined as the conditional probability of being a participant of the JB100 study in contrast to being a participant of current study given observed baseline covariates. OS efficacy analysis was prespecified to use a pooled control population comprising the avelumab control arm and JB100 external control cohort; therefore, results are reported for combined control population.
Time from date of randomization to death, assessed up to 32 months and 12 days (current study) and 41 months (JB100 extended control group)
Overall Survival (OS) - Avelumab + M6223 Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])
時間枠：Time from date of randomization to death, assessed up to 32 months and 12 days (current study) and 41 months (JB100 extended control group)
OS: time from date of randomization to death. OS was analyzed by using PS-based weighted product-limit (Kaplan-Meier) estimates. PS were used as weights to minimize the impact of confounding factors on the estimation of causal treatment effects. Each participant from randomized study was assigned a weight of 1, while participants from external control received a PS-based weight with the sum of weights adding up to number of participants in randomized control arm. Pre-chosen baseline covariates with possible impact on OS outcome was used to calculate the preference score, i.e., a prevalence adjusted PS defined as the conditional probability of being a participant of the JB100 study in contrast to being a participant of current study given observed baseline covariates. OS efficacy analysis was prespecified to use a pooled control population comprising the avelumab control arm and JB100 external control cohort; therefore, results are reported for combined control population.
Time from date of randomization to death, assessed up to 32 months and 12 days (current study) and 41 months (JB100 extended control group)
Overall Survival (OS) - Avelumab + NKTR-255 Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])
時間枠：Time from date of randomization to death, assessed up to 32 months and 12 days (current study) and 41 months (JB100 extended control group)
OS: time from date of randomization to death. OS was analyzed by using PS-based weighted product-limit (Kaplan-Meier) estimates. PS were used as weights to minimize the impact of confounding factors on the estimation of causal treatment effects. Each participant from randomized study was assigned a weight of 1, while participants from external control received a PS-based weight with the sum of weights adding up to number of participants in randomized control arm. Pre-chosen baseline covariates with possible impact on OS outcome was used to calculate the preference score, i.e., a prevalence adjusted PS defined as the conditional probability of being a participant of the JB100 study in contrast to being a participant of current study given observed baseline covariates. OS efficacy analysis was prespecified to use a pooled control population comprising the avelumab control arm and JB100 external control cohort; therefore, results are reported for combined control population.
Time from date of randomization to death, assessed up to 32 months and 12 days (current study) and 41 months (JB100 extended control group)
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 Assessed by Investigator- Avelumab + Sacituzumab Govitecan Versus Avelumab
時間枠：Time from randomization to first observation of progression disease (PD), assessed up to 32 months and 12 days
ORR is defined as percentage of participants who achieved either a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) according to RECIST v1.1 from randomization to first observation of progression disease (PD). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Time from randomization to first observation of progression disease (PD), assessed up to 32 months and 12 days
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 Assessed by Investigator - Avelumab + M6223 Versus Avelumab
時間枠：Time from randomization to first observation of progression disease (PD), assessed up to 32 months and 12 days
ORR is defined as percentage of participants who achieved either a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) according to RECIST v1.1 from randomization to first observation of progression disease (PD). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Time from randomization to first observation of progression disease (PD), assessed up to 32 months and 12 days
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 Assessed by Investigator - Avelumab + NKTR-255 Versus Avelumab
時間枠：Time from randomization to first observation of progression disease (PD), assessed up to 32 months and 12 days
ORR is defined as percentage of participants who achieved either a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) according to RECIST v1.1 from randomization to first observation of progression disease (PD). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Time from randomization to first observation of progression disease (PD), assessed up to 32 months and 12 days
Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 Assessed by Investigator - Avelumab + Sacituzumab Govitecan Versus Avelumab
時間枠：Time from first documented objective response to PD or death due to any cause, assessed up to 32 months and 12 days
DoR was defined as time from first documentation of objective response (Complete Response [CR] or Partial Response [PR]) to PD or death, occurring within 2 scheduled tumor assessments after last evaluable assessment or randomization. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Time from first documented objective response to PD or death due to any cause, assessed up to 32 months and 12 days
Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 Assessed by Investigator Avelumab + M6223 Versus Avelumab
時間枠：Time from first documented objective response to PD or death due to any cause, assessed up to 32 months and 12 days
DoR was defined as time from first documentation of objective response (Complete Response [CR] or Partial Response [PR]) to PD or death, occurring within 2 scheduled tumor assessments after last evaluable assessment or randomization. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Time from first documented objective response to PD or death due to any cause, assessed up to 32 months and 12 days
Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 Assessed by Investigator - Avelumab + NKTR-255 Versus Avelumab
時間枠：Time from first documented objective response to PD or death due to any cause, assessed up to 32 months and 12 days
DoR was defined as time from first documentation of objective response (Complete Response [CR] or Partial Response [PR]) to PD or death, occurring within 2 scheduled tumor assessments after last evaluable assessment or randomization. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Time from first documented objective response to PD or death due to any cause, assessed up to 32 months and 12 days
Serum Concentrations of Avelumab in Avelumab Monotherapy
時間枠：C1D1 and C3D29 (pre-dose and end of infusion); C2D15, C6D71, C9D113, C12D155, C18D239, C24D323, C30D407, C36D491, C42D575, C48D659, and C54D743 (pre-dose) (each cycle is of 2 weeks)
Serum concentrations of Avelumab were measured. "C" in the timeframe below refers to "Cycle" and D refers to "Day".
C1D1 and C3D29 (pre-dose and end of infusion); C2D15, C6D71, C9D113, C12D155, C18D239, C24D323, C30D407, C36D491, C42D575, C48D659, and C54D743 (pre-dose) (each cycle is of 2 weeks)
Serum Concentrations of Avelumab- Avelumab + Sacituzumab Govitecan (SG)
時間枠：C1D1 and C2D29 (pre-dose and end of infusion); C1D15, C3D43, C5D85, C7D127, C9D169, C13D253, C17D337, C21D421, C25D505, C29D589, C33D673, and C37D757 (pre-dose) (each cycle is of 4 weeks)
Serum concentrations of Avelumab in investigational arm (Avelumab + Sacituzumab Govitecan (SG) were measured. "C" in the timeframe below refers to "Cycle" and D refers to "Day".
C1D1 and C2D29 (pre-dose and end of infusion); C1D15, C3D43, C5D85, C7D127, C9D169, C13D253, C17D337, C21D421, C25D505, C29D589, C33D673, and C37D757 (pre-dose) (each cycle is of 4 weeks)
Serum Concentrations of Avelumab- Avelumab + M6623
時間枠：C1D1, C2D15 and C3D29 (pre-dose and end of infusion); C1D2, C2D16 (24 hour) C1D8, C2D22 (168 hours); C6D71, C9D113, C12D155, C18D239, C24D323, C30D407, C36D491, C42D575, C48D659 and C54D743 (Pre-dose) (each cycle is of 2 weeks)
Serum concentrations of Avelumab in investigational arm (Avelumab + M6623) were measured. "C" in the timeframe below refers to "Cycle" and D refers to "Day"
C1D1, C2D15 and C3D29 (pre-dose and end of infusion); C1D2, C2D16 (24 hour) C1D8, C2D22 (168 hours); C6D71, C9D113, C12D155, C18D239, C24D323, C30D407, C36D491, C42D575, C48D659 and C54D743 (Pre-dose) (each cycle is of 2 weeks)
Serum Concentrations of Avelumab- Avelumab + NKTR-255
時間枠：C1D1, C2D29, C3D57 and C5D113 (pre-dose and end of infusion); C1D2, C2D30 (24 hour) C1D8, C2D36 (168 hours); C7D169, C10D253, C13D337, C16D421, C19D505, C22D589, C25D673 and C28D757(Pre-dose) (each cycle is of 4 weeks)
Serum concentrations of Avelumab in investigational arm (Avelumab + NKTR-255) were measured. "C" in the timeframe below refers to "Cycle" and D refers to "Day".
C1D1, C2D29, C3D57 and C5D113 (pre-dose and end of infusion); C1D2, C2D30 (24 hour) C1D8, C2D36 (168 hours); C7D169, C10D253, C13D337, C16D421, C19D505, C22D589, C25D673 and C28D757(Pre-dose) (each cycle is of 4 weeks)
Serum Concentrations of Total Antibody of Sacituzumab Govitecan (SG)
時間枠：C1D1 and C2D22 (Pre-dose and end of infusion); C1D8, C2D29, C3D43, C5D85, C5D92, C7D127, C7D134, C9D169, C9D176, C13D253, C17D337, C21D421, C21D428, C25D505, C29D589 and C33D673 (Pre-dose) (each cycle is of 4 weeks)
Serum concentrations of SG were measured. "C" in the timeframe below refers to "Cycle" and D refers to "Day".
C1D1 and C2D22 (Pre-dose and end of infusion); C1D8, C2D29, C3D43, C5D85, C5D92, C7D127, C7D134, C9D169, C9D176, C13D253, C17D337, C21D421, C21D428, C25D505, C29D589 and C33D673 (Pre-dose) (each cycle is of 4 weeks)
Serum Concentrations of M6223
時間枠：C1D1, C2D15 and C3D29 (pre-dose and end of infusion); C1D2, C2D16 (24 hour) C1D8, C2D22 (168 hours); C6D71, C9D113, C12D155, C18D239, C24D323, C30D407, C36D491, C42D575, C48D659 and C54D743 (Pre-dose) (each cycle is of 2 weeks)
Serum concentrations of M6223 were measured. "C" in the timeframe below refers to "Cycle" and D refers to "Day".
C1D1, C2D15 and C3D29 (pre-dose and end of infusion); C1D2, C2D16 (24 hour) C1D8, C2D22 (168 hours); C6D71, C9D113, C12D155, C18D239, C24D323, C30D407, C36D491, C42D575, C48D659 and C54D743 (Pre-dose) (each cycle is of 2 weeks)
Serum Concentration of NKTR-255
時間枠：C1D1, C2D29, C3D57 and C5D113 (pre-dose and end of infusion); C1D2, C2D30 (24 hour) C1D8, C2D36 (168 hours); C7D169, C10D253, C13D337, C16D421, C19D505, C22D589, C25D673 and C28D757(Pre-dose) (each cycle is of 4 weeks)
Serum concentrations of NKTR-255 were measured. "C" in the timeframe below refers to "Cycle" and D refers to "Day".
C1D1, C2D29, C3D57 and C5D113 (pre-dose and end of infusion); C1D2, C2D30 (24 hour) C1D8, C2D36 (168 hours); C7D169, C10D253, C13D337, C16D421, C19D505, C22D589, C25D673 and C28D757(Pre-dose) (each cycle is of 4 weeks)
Number of Participants With Positive Anti-Drug Antibody (ADA) of Avelumab and Combination Drugs
時間枠：Up to 32 months and 12 days (current study) and 41 months (JB100 extended control group)
Number of participants with positive ADA of Avelumab and combination drugs (Sacituzumab Govitecan [SG], M6223 and NKTR-255) were reported.
Up to 32 months and 12 days (current study) and 41 months (JB100 extended control group)
Change From Baseline in National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy (NCCN-FACT) Bladder Symptom Index- 18 (FBlSI-18) Disease Related Symptoms-Physical Subscale (DRS-P) Scores at Week 13 - Avelumab + SG Versus Avelumab
時間枠：Baseline, Week 13
The NCCN FACT FBlSI-18 is designed to be a stand-alone instrument to measure symptoms and quality of life in participants with urothelial carcinoma and was created using inputs from participants and oncologists. The disease-related symptoms - physical (DRS-P) subscale uses a subset of physical symptoms which are specific to urothelial carcinoma, i.e., pain, weight loss, urination, weakness, dizziness, meeting family needs, appetite, erection in males, and sleep. Each question offers 5 answers: not at all (0), a little bit (1), somewhat (2), quite a bit (3), very much (4). The overall summary range is 0-36. The scores of negatively stated items (e.g., pain) are reversed and added together with the positively stated scores. The sum of these item scores are multiplied by the number of items in the subscale, i.e., by 9, and divided by the number of items answered. In general, higher scores are better than lower scores.
Baseline, Week 13
Change From Baseline in NCCN FACT FBlSI-18 DRS-P Scores at Week 13 - Avelumab + M6223 Versus Avelumab
時間枠：Baseline, Week 13
The NCCN FACT FBlSI-18 is designed to be a stand-alone instrument to measure symptoms and quality of life in participants with urothelial carcinoma and was created using inputs from participants and oncologists. The disease-related symptoms - physical (DRS-P) subscale uses a subset of physical symptoms which are specific to urothelial carcinoma, i.e., pain, weight loss, urination, weakness, dizziness, meeting family needs, appetite, erection in males, and sleep. Each question offers 5 answers: not at all (0), a little bit (1), somewhat (2), quite a bit (3), very much (4). The overall summary range is 0-36. The scores of negatively stated items (e.g., pain) are reversed and added together with the positively stated scores. The sum of these item scores are multiplied by the number of items in the subscale, i.e., by 9, and divided by the number of items answered. In general, higher scores are better than lower scores.
Baseline, Week 13
Change From NCCN FACT FBlSI-18 DRS-P Scores at Week 13 -Avelumab + NKTR-255 Versus Avelumab
時間枠：Baseline, Week 13
The NCCN FACT FBlSI-18 is designed to be a stand-alone instrument to measure symptoms and quality of life in participants with urothelial carcinoma and was created using inputs from participants and oncologists. The disease-related symptoms - physical (DRS-P) subscale uses a subset of physical symptoms which are specific to urothelial carcinoma, i.e., pain, weight loss, urination, weakness, dizziness, meeting family needs, appetite, erection in males, and sleep. Each question offers 5 answers: not at all (0), a little bit (1), somewhat (2), quite a bit (3), very much (4). The overall summary range is 0-36. The scores of negatively stated items (e.g., pain) are reversed and added together with the positively stated scores. The sum of these item scores are multiplied by the number of items in the subscale, i.e., by 9, and divided by the number of items answered. In general, higher scores are better than lower scores.
Baseline, Week 13

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

EMD Serono Research & Development Institute, Inc.

協力者

Merck KGaA, Darmstadt, Germany; Gilead Sciences; Nektar Therapeutics

捜査官

  • スタディディレクター：Medical Responsible、Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

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。

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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)

2022年8月17日

一次修了 (実際)

2025年6月20日

研究の完了 (推定)

2027年1月22日

試験登録日

最初に提出

2022年4月5日

QC基準を満たした最初の提出物

2022年4月13日

最初の投稿 (実際)

2022年4月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月1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10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

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • MS100070_0119
  • 2023 (米国 NIH グラント/契約：GRAMMY Museum Foundation)
  • 2021-003669-36 (EudraCT番号)
  • 2023-510139-12-00 (Ctis)

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

私たちは、臨床試験データの責任ある共有を通じて、公衆衛生の向上に取り組んでいます。 米国と欧州連合の両方で新製品または承認された製品の新しい適応症が承認された後、研究スポンサーおよび/またはその関連会社は、研究プロトコル、匿名化された患者データと研究レベルのデータ、および編集された臨床研究レポートを共有します。正当な研究を実施するために必要な、要求に応じた資格のある科学および医学研究者。 データを要求する方法の詳細については、当社の Web サイト bit.ly/IPD21 を参照してください。

IPD 共有時間枠

米国と欧州連合の両方で新製品または承認された製品の新しい適応症が承認されてから 6 か月以内

IPD 共有アクセス基準

有資格の科学および医学研究者は、データを要求できます。 そのような要求は、会社のポータルに書面で提出する必要があり、研究者の資格の基準と研究提案の正当性に関して内部で審査されます。

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

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

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