이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

국소 진행성 또는 전이성 요로상피암에서 치료로서 Avelumab의 다양한 조합의 안전성 및 효능에 관한 연구(JAVELIN Bladder Medley)

2026년 8월 10일 업데이트: EMD Serono Research & Development Institute, Inc.

1차 백금으로 질병이 진행되지 않은 국소 진행성 또는 전이성 요로상피암 참가자의 유지 치료로서 다른 항종양제와 병용한 Avelumab(MSB0010718C)의 II상, 다기관, 무작위, 공개, 평행 암, 엄브렐러 연구 -화학 요법 포함(JAVELIN Bladder Medley)

이 연구의 목적은 방광암 참가자의 유지 치료로서 다른 항종양제와 조합된 아벨루맙의 안전성과 효능을 평가하는 것입니다.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

256

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

설명

포함 기준:

  • 조직학적으로 확인되고 절제 불가능한 국소 진행성 또는 전이성 요로상피암이 있는 참가자. 이행 세포 및 혼합 이행/비 이행 세포 조직학 모두 허용되지만 이행 세포 암종이 우세한 조직학이어야 합니다.
  • 참가자는 1차 화학요법을 시작할 때 N1-N3 또는 IV기 질병이 있는 IIIA/IIIB기(미국 암 합동 위원회/암 통제 종양 노드 전이 시스템을 위한 국제 연합, 8판)를 기록했습니다.
  • 1차 화학요법의 마지막 용량은 본 연구에서 무작위화되기 4주 이상 10주 이전에 받아야 합니다.
  • 예상 수명 최소 3개월
  • 1L 화학요법의 4~6주기 완료 후 RECIST v1.1 지침에 따른 진행성 질환이 없는 참가자. 이 기준에 기초한 적격성은 화학요법 전 및 화학요법 후 방사선학적 평가(CT/MRI 스캔)의 조사관 검토에 의해 결정될 것입니다.
  • Eastern Cooperative Oncology Group(ECOG) 수행 상태(PS) 0 또는 1
  • 프로토콜에 정의된 적절한 혈액, 간 및 신장 기능
  • 다른 프로토콜 정의 포함 기준이 적용될 수 있음

제외 기준:

  • 이전에 인터루킨-2(IL-2), IL-15, 인터페론 알파(IFN-α) 또는 항 프로그램된 사망 수용체-1(PD-1), 항 프로그램된 사망 리간드 1(PD-L1)을 사용한 면역 요법을 받은 참가자 ), 항 PD-L2, 항 CD137 또는 세포독성 T 세포 림프구-4(CTLA-4) 항체(이필리무맙 포함), 항 TROP2, T 세포 공동자극 또는 면역 체크포인트 경로를 특이적으로 표적으로 하는 기타 항체 또는 약물, 또는 avelumab과 함께 사용되는 연구 약물.
  • 전신 요법이 필요한 무작위 배정 48시간 전에 활동성 감염이 있는 참가자
  • 이전에 알려졌거나 의심되는 과민성이 연구 약물 또는 제제의 구성 요소에 있는 참가자
  • 무작위 배정 후 12개월 이내에 선행 보조 또는 신보조 전신 요법을 받은 참가자
  • 연구 치료제 첫 투여 후 4주 이내에 백신 접종을 받은 참가자 및 시험 기간 동안 비활성화 백신(예: 비활성화 인플루엔자 백신) 및 지역 보건 당국에서 승인 또는 승인한 복제 결함 코로나바이러스 백신의 투여를 제외하고는 참가자가 금지됩니다.
  • 다른 프로토콜 정의 제외 기준이 적용될 수 있음

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: 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.
다른 이름들:
  • MSB0010718C
실험적: 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.
의약품: 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.
다른 이름들:
  • MSB0010718C
의약품: 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.
다른 이름들:
  • IMMU-132
  • GS-0132
  • 트로델비™
실험적: 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.
의약품: 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.
다른 이름들:
  • MSB0010718C
의약품: 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.
실험적: 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.
의약품: 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.
다른 이름들:
  • MSB0010718C
의약품: 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.
다른: 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.
의약품: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
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])
기간: 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])
기간: 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])
기간: 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)
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Overall Survival (OS) -Avelumab + Sacituzumab Govitecan Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])
기간: 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])
기간: 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])
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

EMD Serono Research & Development Institute, Inc.

협력자

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

수사관

  • 연구 책임자: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2022년 8월 17일

기본 완료 (실제)

2025년 6월 20일

연구 완료 (추정된)

2027년 1월 22일

연구 등록 날짜

최초 제출

2022년 4월 5일

QC 기준을 충족하는 최초 제출

2022년 4월 13일

처음 게시됨 (실제)

2022년 4월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 10일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • MS100070_0119
  • 2023 (미국 NIH 보조금/계약: GRAMMY Museum Foundation)
  • 2021-003669-36 (EudraCT 번호)
  • 2023-510139-12-00 (씨티스)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

우리는 임상 시험 데이터의 책임 있는 공유를 통해 공중 보건을 향상시키기 위해 최선을 다하고 있습니다. 미국과 유럽 연합에서 신제품 또는 승인된 제품에 대한 새로운 적응증이 승인된 후, 연구 후원자 및/또는 계열사는 연구 프로토콜, 익명화된 환자 데이터 및 연구 수준 데이터, 편집된 임상 연구 보고서를 다음과 공유합니다. 적법한 연구를 수행하는 데 필요한 자격을 갖춘 과학 및 의학 연구원의 요청 시. 데이터 요청 방법에 대한 자세한 내용은 당사 웹사이트 bit.ly/IPD21에서 확인할 수 있습니다.

IPD 공유 기간

미국과 유럽 연합에서 승인된 제품에 대한 신제품 또는 새로운 적응증 승인 후 6개월 이내

IPD 공유 액세스 기준

자격을 갖춘 과학 및 의료 연구원이 데이터를 요청할 수 있습니다. 이러한 요청은 회사 포털에 서면으로 제출해야 하며 연구자 자격 기준 및 연구 제안의 적법성에 대해 내부적으로 검토합니다.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ANALYTIC_CODE
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다