Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

956

Participants

Timeline

Start Date

January 24, 2024

Primary Completion Date

December 31, 2030

Study Completion Date

December 31, 2030

Conditions
Metastatic Urothelial Cancer
Interventions
DRUG

BT8009

Participants will receive BT8009 on Days 1, 8, and 15 of every 21-day cycle.

DRUG

BT8009

Participants will receive BT8009 on Days 1 and 8 of every 21-day cycle.

DRUG

BT8009

Participants will receive BT8009 on days 1, 8 +/- 15 schedule of every 21-day cycle.

DRUG

Pembrolizumab

Participants will receive Pembrolizumab on Day 1 of every 21-day cycle. Pembrolizumab infusion will be started 30 minutes following the completion of the BT8009 infusion.

DRUG

Gemcitabine + cisplatin Or carboplatin

Participants will receive Gemcitabine on Days 1 and 8 of every 21-day cycle plus cisplatin Or carboplatin on Day 1 of every 21-day cycle.

DRUG

Avelumab

After 4-6 cycles of Gemcitabine + Cisplatin or Carboplatin participants will receive maintenance Avelumab, if clinically indicated, on Days 1 and 15 each 28-day cycle.

Trial Locations (172)

333

RECRUITING

Linkou Chang Gung Memorial Hospital (CGMHLK), Taoyuan

704

RECRUITING

National Cheng Kung University Hospital, Tainan City

710

RECRUITING

Chi Mei Medical Center, Tainan City

807

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

1020

RECRUITING

Krankenhaus der Barmherzigen Brüder Wien, Vienna

1090

RECRUITING

Medizinische Universitaet Wien, Vienna

2031

RECRUITING

Prince of Wales Hospital, Randwick

2148

RECRUITING

Blacktown Hospital, New South Wales

2310

RECRUITING

Calvary Mater Newcastle, Hunter

3000

RECRUITING

Universitaire Ziekenhuizen Leuven, Leuven

3220

RECRUITING

Barwon Health, Geelong

3722

RECRUITING

Severance Hospital, Yonsei University Health System, Seoul

4020

RECRUITING

Urologie und Andrologie Ordensklinikum Linz GmbH Elisabethinen, Linz

4066

RECRUITING

Icon Cancer Centre, South Brisbane

4101

RECRUITING

Mater Misericordiae Ltd, South Brisbane, Brisbane

4102

RECRUITING

Princess Alexandra Hospital, Woolloongabba

4215

RECRUITING

Gold Coast University Hospital, Southport

4814

RECRUITING

Townsville Hospital and Health Service, Douglas

5000

RECRUITING

Cancer Research SA, Adelaide

5100

RECRUITING

Azienda Ospedaliera Santa Maria di Terni, Terni

5300

RECRUITING

Fundación CORI para la investigación y Prevención del Cancer, La Rioja

6000

RECRUITING

LTD High Technology Hospital Medcenter, Batumi

6009

RECRUITING

Sir Charles Gairdner Hospital, Nedlands

6060

RECRUITING

ASBL Grand Hôpital de Charleroi (GHdC), Site Notre Dame, Charleroi

7400

RECRUITING

Somogy Varmegyei Kaposi Mor Oktato Korhaz, Kaposvár

8500

RECRUITING

Clinica Viedma S.A., Viedma

9000

RECRUITING

General Hospital Maria Middelares, Ghent

RECRUITING

University Hospital Gent, Ghent

RECRUITING

Aalborg University Hospital, Aalborg

10002

RECRUITING

National Taiwan University Hospital, Taipei

10032

WITHDRAWN

Columbia University Irving Medical Center, New York

10408

RECRUITING

National Cancer Center, Goyang

10461

RECRUITING

Montefiore Medical Center, The Bronx

11000

RECRUITING

University Clinical Center of Serbia, Clinic of Urology, Belgrade

13273

RECRUITING

Institut Paoli-Calmettes, Marseille

15706

RECRUITING

Hospital Clinico Universitario de Santiago, Santiago de Compostela

16132

RECRUITING

Ospedale Policlinico San Martino IRCCS, Genova

19713

RECRUITING

Medical Oncology Hematology Consultants, Newark

20014

RECRUITING

Hospital Universitario Donostia, San Sebastián

20141

RECRUITING

Istituto Europeo di Oncologia, Milan

22030

RECRUITING

Trakya University Medical Faculty, Edirne

25000

RECRUITING

Service d'Oncologie Medicale - CHRU Besancon, Besançon

28007

RECRUITING

Hospital General Universitario Gregorio Maranon, Madrid

28027

RECRUITING

Clinica Universidad de Navarra - Madrid, Madrid

28040

RECRUITING

Hospital Fundacion Jimenez Diaz, Madrid

28041

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

28046

RECRUITING

Hospital Universitario La Paz, Madrid

29425

RECRUITING

Medical University of South Carolina (MUSC) - Hollings Cancer Center, Charleston

29572

RECRUITING

Carolina Urologic Research Center, Myrtle Beach

31008

RECRUITING

Clinica Universidad de Navarra - Pamplona, Pamplona

32266

RECRUITING

Cancer Specialists of North Florida, Jacksonville

33000

RECRUITING

CHU Bordeaux - Hopital Saint-Andre, Bordeaux

33076

RECRUITING

Institut Bergonie, Bordeaux

33081

RECRUITING

Centro Riferimento Oncologico - Aviano, Aviano

33136

RECRUITING

University of Miami - Sylvester Comprehensive Cancer Center, Miami

33140

RECRUITING

Mount Sinai Medical Center of Florida, Inc., Miami Beach

33165

WITHDRAWN

AP Medical Research, Miami

33612

RECRUITING

Moffitt, Tampa

34000

RECRUITING

Goztepe Prof. Dr. Suleyman Yalcin City Hospital, Istanbul

34298

RECRUITING

ICM - Institut Regional du Cancer de Montpellier, Montpellier

34899

RECRUITING

Istinye Universitesi VM Medical Park Pendik Hastanesi, Istanbul

35015

RECRUITING

Chungnam National University Hospital, Daejeon

35016

RECRUITING

Hospital Universitario Insular de Gran Canaria, Las Palmas de Gran Canaria

35575

RECRUITING

Medical Point Izmir Hospital, Izmir

37075

RECRUITING

Georg-August-Universitaet Goettingen Stiftung oeffentlichen Rechts Universitaetsmedizin Goettingen, Göttingen

37203

RECRUITING

SCRI Oncology Partners, Nashville

39008

RECRUITING

Hospital Universitario Marques de Valdecilla, Santander

40202

RECRUITING

UofL Health Brown Cancer Center, Louisville

40447

RECRUITING

China Medical University Hospital, Taichung

41380

RECRUITING

Kocaeli University Faculty of Medicine, Kocaeli

44106

WITHDRAWN

University Hospitals Cleveland Medical Center, Cleveland

44625

RECRUITING

Marien Hospital Herne - Universitaetsklinikum der Ruhr-Universitaet Bochum, Herne

45147

RECRUITING

Universitaetsklinikum Essen, Essen

46009

RECRUITING

Instituto Valenciano de Oncologia, Valencia

48149

RECRUITING

Universitaetsklinikum Muenster, Münster

49013

WITHDRAWN

Universitaetsklinikum Freiburg, Freiburg im Breisgau

49503

WITHDRAWN

Corewell Health, Grand Rapids

50309

RECRUITING

Mission Cancer + Blood, Des Moines

54100

RECRUITING

Centre d'Oncologie de Gentilly, Nancy

58128

RECRUITING

Chonnam National University Hwasun Hospital, Gwangju

60488

RECRUITING

Krankenhaus Nordwest GmbH, Frankfurt

60590

RECRUITING

Universitaetsklinikum Frankfurt - Klinikum der Johann Wolfgang Goethe Universitaet, Frankfurt

62702

RECRUITING

Southern Illinois University (SIU) - Simmons Cancer Institute, Springfield

66205

RECRUITING

University of Kansas Cancer Center, Westwood

68130

RECRUITING

Nebraska Cancer Specialists, Omaha

WITHDRAWN

XCancer Omaha/Urology Cancer Center, Omaha

68167

RECRUITING

Universitaetsmedizin Mannheim, Mannheim

69008

RECRUITING

Centre Leon Berard, Lyon

69495

RECRUITING

HCL Centre Hospitalier Lyon Sud, Pierre-Bénite

70809

RECRUITING

Mary Bird Perkins Cancer Center, Baton Rouge

72000

RECRUITING

Groupement de Cooperation Sanitaire (GCS) ELSAN - Clinique Victor Hugo, Le Mans

72076

RECRUITING

Universitaetsklinikum Tuebingen, Tübingen

72205

RECRUITING

University of Arkansas for Medical Sciences, Little Rock

75014

RECRUITING

Institut Mutualiste Montsouris, Paris

75015

RECRUITING

AP-HP Hopital Europeen Georges Pompidou, Paris

76104

RECRUITING

The Center for Cancer and Blood Disorders, Fort Worth

77030

RECRUITING

MD Anderson Cancer Center, Houston

78229

RECRUITING

University of Texas Health Science Center at San Antonio, San Antonio

79110

RECRUITING

Universitaetsklinikum Freiburg, Freiburg im Breisgau

80131

RECRUITING

"Istituto Nazionale Tumori IRCCS Fondazione G. Pascale", Napoli

80218

RECRUITING

Rocky Mountain Cancer Center, Denver

86000

RECRUITING

CHU Poitiers - Pole Regional de Cancerologie de Poitiers (PRC), Poitiers

87042

RECRUITING

CHU de Limoges - Hopital Dupuytren 1, Limoges

92835

RECRUITING

Virginia K. Crosson Cancer Center at St. Jude Medical Center, Fullerton

92868

RECRUITING

University of California - Irvine Medical Center, Orange

94158

RECRUITING

University of California, San Francisco (UCSF), San Francisco

94574

RECRUITING

Adventist Health St. Helena, St. Helena

94805

RECRUITING

Institut Gustave Roussy, Villejuif

119228

RECRUITING

National University Hospital, Singapore

168583

RECRUITING

National Cancer Centre Singapore, Singapore

2520598

RECRUITING

Oncocentro APYS, Viña del Mar

3109601

RECRUITING

Rambam Health Care Campus, Haifa

4428164

RECRUITING

Meir Medical Center, Kfar Saba

4941492

RECRUITING

Rabin Medical Center - Beilinson Hospital, Petah Tikva

6423906

RECRUITING

Sourasky Medical Center, Tel Aviv

7030001

RECRUITING

Shamir Medical Center, Be’er Ya‘aqov

7500921

RECRUITING

Fundación Arturo López Pérez (FALP), Santiago

8420000

RECRUITING

Centro de Investigacion Clinica Bradford Hill, Santiago

9112001

RECRUITING

Hadassah Hebrew University Medical Center, Jerusalem

06520-8028

RECRUITING

Yale University School of Medicine - Yale Cancer Center, New Haven

08816

RECRUITING

Astera Cancer Care, East Brunswick

01009

WITHDRAWN

Summit Health (New Jersey Urology), Voorhees Township

08043

WITHDRAWN

Summit Health (New Jersey Urology), Voorhees Township

C1120AAT

RECRUITING

Centro de Diagnostico Urologico S.R.L., Buenos Aires

C1280AEB

RECRUITING

Hospital Britanico de Buenos Aires, Buenos Aires

C1419AHN

RECRUITING

Hospital Sirio Libanes de Buenos Aires, Buenos Aires

C1426ANZ

RECRUITING

Instituto Alexander Fleming, Buenos Aires

R8324

RECRUITING

Fundacion Medica Rio Negro y Neuquen, Cipolletti

X5008HHW

RECRUITING

Centro Medico Privado (CEMAIC), Córdoba

B2700CPM

RECRUITING

Centro De Investigacion Pergamino S.A., Pergamino

S2000KZE

RECRUITING

Instituto de Oncologia de Rosario, Santa Fe

14784-400

RECRUITING

Fundacao PIO XII - Hospital de Amor, Barretos

88020-210

RECRUITING

CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina, Florianópolis

98700-000

RECRUITING

Oncosite - Centro de Pesquisa Clinica Em Oncologia, Ijuí

90110-270

RECRUITING

Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa, Porto Alegre

90610-000

RECRUITING

Hospital Sao Lucas - Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS), Porto Alegre

01327-001

RECRUITING

Hospital Alemao Oswaldo Cruz, São Paulo

01509-010

RECRUITING

Hospital A.C. Camargo Cancer Center, São Paulo

V1Y 5L3

RECRUITING

British Columbia Cancer Agency- Centre for the Southern Interior, Kelowna

H4A 3J1

RECRUITING

McGill University Health Center, Québec

M5G 2M9

RECRUITING

Princess Margaret Hospital, Toronto

R3E 0V9

RECRUITING

Cancer Care Manitoba, Winnipeg

06189

RECRUITING

Centre Antoine-Lacassagne, Nice

0141

RECRUITING

The First University Clinic of Tbilisi State Medical University, Tbilisi

0159

RECRUITING

New Vision University Hospital, Tbilisi

0186

RECRUITING

Multiprofile Clinic Consilium Medulla LTD, Tbilisi

01307

RECRUITING

Universitaetsklinikum Carl Gustav Carus Dresden, Dresden

D-72622

RECRUITING

Studienpraxis Urologie, Nürtingen

H-1122

RECRUITING

Orszagos Onkologiai Intezet, Budapest

H-1145

RECRUITING

Budapesti Uzsoki Utcai Korhaz, Budapest

H-6000

RECRUITING

Bacs-Kiskun Varmegyei Oktatokorhaz, Kecskemét

80-210

RECRUITING

Copernicus PL Sp. z o.o., Wojewodzkie Centrum Onkologii, Gdansk

81-519

RECRUITING

Spitale Pomorskie Sp.z.o.o ODDZIAL ONKOLOGII KLINICZNEJ, Gdynia

31-559

RECRUITING

SCM Sp. z o.o., Krakow

05-135

RECRUITING

Mazowiecki Szpital Onkologiczny, Wieliszew

02841

RECRUITING

Korea University Anam Hospital, Seoul

03080

RECRUITING

Seoul National University Hospital, Seoul

05505

RECRUITING

Asan Medical Center, Seoul

06351

RECRUITING

Samsung Medical Center, Seoul

08026

RECRUITING

Hospital de la Santa Creu i Sant Pau, Barcelona

08036

RECRUITING

Hospital Clinic Barcelona, Barcelona

08908

RECRUITING

Institut Catala d'Oncologia - L'Hospitalet, Barcelona

06680

RECRUITING

Liv Hospital Ankara, Ankara

BS2 8ED

RECRUITING

Bristol Haematology and Oncology Centre, Bristol

CB2 0QQ

RECRUITING

Addenbrooke's Hospital, Cambridge

EC1A 7BE

RECRUITING

St. Bartholomew's Hospital, London

NW1 2PG

RECRUITING

University College London Hospital, London

NW3 2QG

RECRUITING

Royal Free London NHS Foundation Trust, London

W6 8RF

RECRUITING

Charing Cross Hospital, London

M20 4BX

RECRUITING

The Christie NHS Foundation Trust, Manchester

PL6 8DH

RECRUITING

Derriford Hospital, Plymouth

SM2 5PT

RECRUITING

The Royal Marsden Hospital, Sutton

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