Tutkimus avelumabin eri yhdistelmien turvallisuudesta ja tehokkuudesta paikallisesti edenneen tai metastaattisen virtsaputken karsinooman hoitona (JAVELIN Bladder Medley)
maanantai 10. elokuuta 2026 päivittänyt: EMD Serono Research & Development Institute, Inc.
Vaiheen II, monikeskus, satunnaistettu, avoin, rinnakkaishaarainen, sateenvarjotutkimus avelumabista (MSB0010718C) yhdistelmänä muiden kasvainten vastaisten aineiden kanssa ylläpitohoitona osallistujille, joilla on paikallisesti edennyt tai metastaattinen virtsaputken karsinooma, jonka tauti ei ensin levinnyt. -Sisältää kemoterapiaa (JAVELIN Bladder Medley)
Tämän tutkimuksen tarkoituksena on arvioida avelumabin turvallisuutta ja tehoa yhdessä muiden kasvainlääkkeiden kanssa ylläpitohoitona virtsarakon syöpää sairastavilla potilailla.
Tutkimuksen yleiskatsaus
Tila
Aktiivinen, ei rekrytointi
Interventio / Hoito
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
256
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Bedford Park, Australia
- Flinders Medical Centre
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Footscray, Australia
- Sunshine Hospital - PARENT
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Kurralta Park, Australia
- Ashford Cancer Centre Research
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Liverpool, Australia
- Liverpool Hospital - PARENT
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Newcastle, Australia
- Calvary Mater Newcastle - PARENT
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Southport, Australia
- Tasman Oncology Research Ltd - Oncology
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Sydney, Australia
- Macquarie University Hospital - PARENT
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Westmead, Australia
- The Kinghorn Can Cen
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Antwerp, Belgia
- ZNA Middelheim - Middelheim - account 2
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Brasschaat, Belgia
- AZ Klina - PARENT
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Brussels, Belgia
- Institut Jules Bordet - Medical Oncology
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Ghent, Belgia
- Universitair Ziekenhuis Gent - Medical Oncology
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Kortrijk, Belgia
- AZ Groeninge - Campus Kennedylaan - account 2
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Libramont, Belgia
- Centre Hospitalier de l'Ardenne - PARENT
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Liège, Belgia
- CHU de Liège - PARENT
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Wuerzburg, Belgia
- Universitaetsklinikum Wuerzburg - Klinik u. Poliklinik f. Urologie u. Kinderurologie
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Badajoz, Espanja
- Hospital Infanta Cristina - Unidad de Fase I
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Barcelona, Espanja
- Hospital del Mar - Servicio de Oncologia
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Barcelona, Espanja
- Hospital de la Santa Creu i Sant Pau - Dept of Oncology
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Barcelona, Espanja
- Hospital Clinic de Barcelona - Servicio de Oncologia
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Barcelona, Espanja
- Hospital Universitario Virgen del Rocio - Oncology Service
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Córdoba, Espanja
- Hospital Universitario Reina Sofia - Dept of Oncology
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Elche, Espanja
- Hospital General Universitario de Elche - Servicio de Oncologia
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Lugo, Espanja
- Hospital Universitario Lucus Augusti - Oncology
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Madrid, Espanja
- Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica
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Manresa, Espanja
- ALTHAIA, Xarxa assistencial Universitaria de Manresa - Oncology Dept
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Daejeon, Etelä -Korea
- Chungnam National University Hospital - Department of Internal Medicine (Rheumatology)
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Gyeonggi-do, Etelä -Korea
- National Cancer Center
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Seongnam-si, Etelä -Korea
- Seoul National University Bundang Hospital
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Seoul, Etelä -Korea
- Asan Medical Center
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Seoul, Etelä -Korea
- Samsung Medical Center
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Seoul, Etelä -Korea
- Seoul National University Hospital
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Seoul, Etelä -Korea
- Severance Hospital, Yonsei University Health System
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Seoul, Etelä -Korea
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Bologna, Italia
- Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS - Oncologia Medica
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Florence, Italia
- Azienda Ospedaliera Universitaria Careggi - S.O.D. di Oncologia Medica
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Forlì, Italia
- IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST - Oncologia
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Milan, Italia
- Ospedale San Raffaele - U.O. di Oncologia Medica
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Milan, Italia
- Fondazione IRCCS Istituto Nazionale dei Tumori - S.S. Oncologia Medica Genitourinaria
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Misterbianco, Italia
- Humanitas Istituto Clinico Catanese - Oncologia Medica
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Naples, Italia
- Istituto Nazionale Tumori Fondazione G. Pascale - Oncologia Medica A
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Naples, Italia
- Istituto Nazionale Tumori Regina Elena IRCCS - Urologia
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Padova, Italia
- IOV - Istituto Oncologico Veneto IRCCS - U.O. Oncologia Medica 1
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Pisa, Italia
- Azienda Ospedaliero Universitaria Pisana - U.O. Oncologia
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Ravenna, Italia
- Ospedale Santa Maria Delle Croci
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Rome, Italia
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
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San Giovanni Rotondo, Italia
- IRCCS Ospedale Casa Sollievo della Sofferenza - Dipartimento di Oncologia Medica
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Terni, Italia
- Azienda Ospedaliera S. Maria Di Terni - S.C. Oncologia Medica
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Brampton, Kanada
- William Osler Health System - Brampton Civic Hospital
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Greenfield Park, Kanada
- CISSS de la Monteregie-Centre - Hospital Charles Le Moyne
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Montreal, Kanada
- CHUM Centre de Recherche
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Ottawa, Kanada
- The Ottawa Hospital Cancer Centre
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Athens, Kreikka
- General Hospital of Athens "Alexandra"
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Athens, Kreikka
- University General Hospital "Attikon"
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Athens, Kreikka
- Athens Medical Center
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Thessaloniki, Kreikka
- Euromedica General Clinic of Thessaloniki
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Angers, Ranska
- ICO - Site Paul Papin - service d'oncologie medicale
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Bordeaux, Ranska
- Institut Bergonié - Service d'Oncologie Médicale
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Caen, Ranska
- Centre François Baclesse - Pathologies Gynecologiques
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Créteil, Ranska
- Hôpital Henri Mondor - Service d'Oncologie Médicale
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Le Mans, Ranska
- Clinique Victor Hugo - Centre Jean Bernard - Service d'Oncologie Médical
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Lyon, Ranska
- Centre Leon Berard - Service d'Oncologie Medicale
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Marseille, Ranska
- Hôpital de la Timone - service d'urologie
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Nîmes, Ranska
- Hopital Caremeau - Service Hématologie Clinique/Oncologie Médicale
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Paris, Ranska
- Hôpital Cochin - Hematologie et Oncologie Médicale
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Poitiers, Ranska
- CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale
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Rennes, Ranska
- CRLCC Eugene Marquis - Service d'Oncologie médicale
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Saint-Herblain, Ranska
- ICO - Site René Gauducheau - Service d'Oncologie medicale
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Strasbourg, Ranska
- Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale
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Strasbourg, Ranska
- Clinique Sainte-Anne - Service d'Oncologie Médicale
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Hauts De Seine
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Suresnes, Hauts De Seine, Ranska, 92151
- Hôpital Foch - Service d'Oncologie Médicale
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Essen, Saksa
- Universitaetsklinikum Essen - Westdeutsches Tumorzentrum
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Frankfurt, Saksa
- Universitaetsklinikum Frankfurt Goethe-Universitaet - Urologie und Kinderurologie2
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Halle, Saksa
- Universitaetsklinikum Wuerzburg - Klinik u. Poliklinik f. Urologie u. Kinderurologie
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Mönchengladbach, Saksa
- Kliniken Maria Hilf GmbH - Klinik fuer Urologie
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Münster, Saksa
- Universitaetsklinikum Muenster - Klinik und Poliklinik fuer Urologie
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Tübingen, Saksa
- Universitaetsklinikum Tuebingen - Klinik fuer Urologie
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North Rhine-Westphalia
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Muenchen, North Rhine-Westphalia, Saksa, 41063
- Kliniken Maria Hilf GmbH - Klinik fuer Urologie
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Saxony-Anhalt
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Halle, Saxony-Anhalt, Saksa, 0044384
- Universitaetsklinikum Halle (Saale) - Universitaetsklinik und Poliklinik fuer Urologie
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Kaohsiung City, Taiwan
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung City, Taiwan
- Kaohsiung Chang Gung Memorial Hospital
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Taichung, Taiwan
- China Medical University Hospital
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Tainan, Taiwan
- Chi Mei Hospital, Liouying
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Taipei, Taiwan
- National Taiwan University Hospital
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Taipei, Taiwan
- Taipei Veterans General Hospital
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Taoyuan, Taiwan
- Chang Gung Memorial Hospital,Linkou
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Manchester, Yhdistynyt kuningaskunta
- The Christie Hospital - Dept of Oncology
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Preston, Yhdistynyt kuningaskunta
- Royal Preston Hospital - Rosemere Cancer Centre
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Greater London
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London, Greater London, Yhdistynyt kuningaskunta, 0024514
- Barts Hospital - Dept of Medical Oncology
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Idaho
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Coeur d'Alene, Idaho, Yhdysvallat, 83814
- Beacon Cancer Care
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Kansas
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Kansas City, Kansas, Yhdysvallat, 66205
- University of Kansas Medical Center Research Institute, Inc. - 3901 Rainbow (MAIN)
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Maryland
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Baltimore, Maryland, Yhdysvallat, 21287
- The Johns Hopkins Hospital
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Baltimore, Maryland, Yhdysvallat, 21287-7049
- Johns Hopkins University
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Missouri
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Kansas City, Missouri, Yhdysvallat, 66204
- AMR Kansas City, Formerly Center for Pharmaceutical Research, an AMR company - Kansas City, MO at St. Joseph Medical Center
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Washington
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Seattle, Washington, Yhdysvallat, 98109
- Seattle Cancer Care Alliance
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Tacoma, Washington, Yhdysvallat, 98405
- Multicare Health System Tacoma General Hospital
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Wisconsin
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Madison, Wisconsin, Yhdysvallat, 53706
- University of Wisconsin Cancer Center
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
Sisällyttämiskriteerit:
- Osallistujat, joilla on histologisesti vahvistettu, ei-leikkauskykyinen paikallisesti edennyt tai metastaattinen uroteelisyövä. Sekä siirtymäsolujen että sekamuotoiset siirtymävaiheen/ei-siirtymäsolujen histologiat ovat sallittuja, mutta siirtymäsolukarsinooman on oltava vallitseva histologia
- Osallistujat ovat dokumentoineet vaiheen IIIA/IIIB N1-N3-taudin tai vaiheen IV taudin (American Joint Committee on Cancer/International Union for Cancer Control Tumor Node Metastasis System, 8. painos) mukaan ensimmäisen linjan kemoterapian alussa.
- Ensimmäisen linjan kemoterapian viimeinen annos on täytynyt saada vähintään 4 viikkoa ja enintään 10 viikkoa ennen satunnaistamista tässä tutkimuksessa
- Arvioitu elinajanodote vähintään 3 kuukautta
- Osallistujat, joilla ei ole etenevää sairautta RECIST v1.1 -ohjeiden mukaisesti 4–6 1 litran kemoterapiasyklin jälkeen. Tähän kriteeriin perustuva kelpoisuus määräytyy kemoterapiaa edeltävien ja kemoterapian jälkeisten radiologisten arvioiden (CT/MRI-skannaukset) perusteella.
- Eastern Cooperative Oncology Groupin (ECOG) suorituskykytila (PS) 0 tai 1
- Riittävä hematologinen, maksan ja munuaisten toiminta protokollan mukaisesti
- Muita protokollassa määriteltyjä sisällyttämiskriteerejä voidaan soveltaa
Poissulkemiskriteerit:
- Osallistujat, jotka ovat saaneet aikaisempaa immunoterapiaa interleukiini-2:lla (IL-2), IL-15:llä, interferoni alfalla (IFN-α) tai anti-ohjelmoidulla kuolemanreseptorilla 1 (PD-1), anti-ohjelmoidulla kuoleman ligandilla 1 (PD-L1) ), anti-PD-L2-, anti-CD137- tai sytotoksinen T-solulymfosyytti-4 (CTLA-4) -vasta-aine (mukaan lukien ipilimumabi), anti-TROP2, mikä tahansa muu vasta-aine tai lääke, joka kohdistuu spesifisesti T-solujen kostimulaatio- tai immuunitarkastuspistereitteihin, tai mikä tahansa tutkimuslääkkeitä, joita käytetään yhdessä avelumabin kanssa.
- Osallistujat, joilla on aktiivinen infektio 48 tuntia ennen satunnaistamista, jotka vaativat systeemistä hoitoa
- Osallistujat, joiden tiedetään aiemmin tai epäillään olevan yliherkkiä tutkimuslääkkeille tai jollekin niiden formulaatioiden aineosalle
- Osallistujat, jotka ovat saaneet systeemistä adjuvantti- tai neoadjuvanttihoitoa 12 kuukauden sisällä satunnaistamisesta
- Osallistujat, jotka on rokotettu 4 viikon kuluessa ensimmäisestä tutkimushoidon annoksesta ja tutkimuksen aikana, ovat kiellettyjä paitsi inaktivoitujen rokotteiden (esimerkiksi inaktivoitujen influenssarokotteiden) ja paikallisten terveysviranomaisten hyväksymien tai hyväksymien koronavirusrokotteiden, joiden replikaatiokyky on puutteellinen.
- Muita protokollan määrittelemiä poissulkemiskriteerejä voidaan soveltaa
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: 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.
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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.
Muut nimet:
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Kokeellinen: 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.
|
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.
Muut nimet:
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.
Muut nimet:
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Kokeellinen: 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.
|
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.
Muut nimet:
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.
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Kokeellinen: 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.
|
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.
Muut nimet:
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.
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Muut: 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.
|
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.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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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])
Aikaikkuna: 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)
|
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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])
Aikaikkuna: 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])
Aikaikkuna: 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)
Aikaikkuna: 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.
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Up to 32 months and 12 days (Current study) and 61 months and 11 days (JB100 extended control group)
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Overall Survival (OS) -Avelumab + Sacituzumab Govitecan Versus Avelumab Monotherapy (Avelumab [Control Group] + JB 100 [External Control])
Aikaikkuna: 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])
Aikaikkuna: 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])
Aikaikkuna: 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
Aikaikkuna: Time from randomization to first observation of progression disease (PD), assessed up to 32 months and 12 days
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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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
|
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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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Yhteistyökumppanit
Tutkijat
- Opintojohtaja: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
- Naing A, McKean M, Tolcher A, Victor A, Hu P, Gao W, Nogueira Filho MAF, Kitzing T, Gleicher S, Holland D, Richter E, Tadjalli-Mehr K, Siu LL. TIGIT inhibitor M6223 as monotherapy or in combination with bintrafusp alfa in patients with advanced solid tumors: a first-in-human, phase 1, dose-escalation trial. J Immunother Cancer. 2025 Feb 10;13(2):e010584. doi: 10.1136/jitc-2024-010584.
- Hoffman-Censits J, Grivas P, Powles T, Hawley J, Tyroller K, Seeberger S, Guenther S, Jacob N, Mehr KT, Hahn NM. The JAVELIN Bladder Medley trial: avelumab-based combinations as first-line maintenance in advanced urothelial carcinoma. Future Oncol. 2024 Feb;20(4):179-190. doi: 10.2217/fon-2023-0492. Epub 2023 Sep 6.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Keskiviikko 17. elokuuta 2022
Ensisijainen valmistuminen (Todellinen)
Perjantai 20. kesäkuuta 2025
Opintojen valmistuminen (Arvioitu)
Perjantai 22. tammikuuta 2027
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Tiistai 5. huhtikuuta 2022
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Keskiviikko 13. huhtikuuta 2022
Ensimmäinen Lähetetty (Todellinen)
Torstai 14. huhtikuuta 2022
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Tiistai 1. syyskuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Maanantai 10. elokuuta 2026
Viimeksi vahvistettu
Lauantai 1. elokuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Urogenitaaliset sairaudet
- Urogenitaaliset kasvaimet
- Neoplasmat sivustoittain
- Neoplasmat
- Miesten urogenitaaliset sairaudet
- Urologiset sairaudet
- Naisten virtsa- ja sukupuolielinten sairaudet
- Naisten virtsa- ja sukupuolielinten sairaudet ja raskauden komplikaatiot
- Neoplasmat histologisen tyypin mukaan
- Kasvaimet, rauhas- ja epiteelikasvaimet
- Urologiset kasvaimet
- Karsinooma
- Virtsarakon sairaudet
- Virtsarakon kasvaimet
- Karsinooma, siirtymäsolu
- Antineoplastiset aineet, immunologiset
- Antineoplastiset aineet
- Immunologiset tekijät
- Huumeiden fysiologiset vaikutukset
- Immunokonjugaatit
- avelumabi
- sacituzumab Govitecan
- NKTR-255
Muut tutkimustunnusnumerot
- MS100070_0119
- 2023 (Yhdysvaltain NIH-apuraha/sopimus: GRAMMY Museum Foundation)
- 2021-003669-36 (EudraCT-numero)
- 2023-510139-12-00 (Ctis)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
Olemme sitoutuneet parantamaan kansanterveyttä jakamalla vastuullisesti kliinisiä tutkimuksia koskevia tietoja.
Kun uusi tuote tai uusi käyttöaihe hyväksytylle tuotteelle on hyväksytty sekä Yhdysvalloissa että Euroopan unionissa, tutkimuksen rahoittaja ja/tai sen tytäryhtiöt jakavat tutkimusprotokollat, anonymisoidut potilastiedot ja tutkimustason tiedot sekä muokatut kliiniset tutkimusraportit päteviä tieteellisiä ja lääketieteellisiä tutkijoita pyynnöstä, jos se on tarpeen laillisen tutkimuksen suorittamiseksi.
Lisätietoja tietojen pyytämisestä löytyy nettisivuiltamme bit.ly/IPD21
IPD-jaon aikakehys
Kuuden kuukauden kuluessa uuden tuotteen hyväksymisestä tai hyväksytyn tuotteen uudesta käyttöaiheesta sekä Yhdysvalloissa että Euroopan unionissa
IPD-jaon käyttöoikeuskriteerit
Pätevät tieteelliset ja lääketieteen tutkijat voivat pyytää tietoja.
Tällaiset pyynnöt tulee toimittaa kirjallisesti yrityksen portaaliin, ja ne käydään sisäisesti läpi tutkijan pätevyyskriteerien ja tutkimusehdotuksen oikeutuksen osalta.
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
- ANALYTIC_CODE
- CSR
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Joo
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .