Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)
NCT ID: NCT06225596
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
956 participants
INTERVENTIONAL
2024-01-24
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1: BT8009 Arm 1
Participants will receive BT8009 and a standard dose of pembrolizumab.
BT8009
Participants will receive BT8009 on Days 1, 8, and 15 of every 21-day cycle.
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.
Cohort 1: BT8009 Arm 2
Participants will receive BT8009 and a standard dose of pembrolizumab.
BT8009
Participants will receive BT8009 on Days 1 and 8 of every 21-day cycle.
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.
Cohort 1: Arm 3
Participants will receive Platinum-based combination chemotherapy +/- avelumab maintenance
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.
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.
Cohort 2: BT8009 Arm 1
Participants will receive BT8009.
BT8009
Participants will receive BT8009 on Days 1, 8, and 15 of every 21-day cycle.
Cohort 2: BT8009 Arm 2
Participants will receive BT8009.
BT8009
Participants will receive BT8009 on Days 1 and 8 of every 21-day cycle.
Cohort 2: Arm 3: BT8009 (Not Recruiting)
Participants will receive BT8009 and a standard dose of pembrolizumab.
BT8009
Participants will receive BT8009 on days 1, 8 +/- 15 schedule of every 21-day cycle.
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.
Interventions
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BT8009
Participants will receive BT8009 on Days 1, 8, and 15 of every 21-day cycle.
BT8009
Participants will receive BT8009 on Days 1 and 8 of every 21-day cycle.
BT8009
Participants will receive BT8009 on days 1, 8 +/- 15 schedule of every 21-day cycle.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Measurable disease as defined by RECIST v1.1.
* Histologically or cytologically confirmed locally advanced (unresectable) or metastatic UC of the renal pelvis, ureter, bladder, or urethra.
* Archival or fresh tumor tissue comprising muscle-invasive UC or locally advanced or metastatic UC should be available for submission to central laboratory.
* Negative pregnancy test for women of childbearing potential (WOCBP) (negative serum test at Screening and negative urine or serum test within 72 hours prior to the first dose).
* Cohort 1: Previously Untreated: Eligible to receive platinum-based chemotherapy (either cisplatin- or carboplatin-based chemotherapy based on Investigator decision.
* Cohort 1: Participants must not have received prior systemic therapy for locally advanced or metastatic UC with the following exceptions:
1. Prior local intravesical chemotherapy, local surgery when full resection is not achieved, local immunotherapy, and radiotherapy are permitted if completed at least 4 weeks prior to the initiation of study treatment and all acute toxicities have resolved.
2. Prior neoadjuvant/adjuvant chemotherapy or monomethyl auristatin E (MMAE)-based therapy with recurrence \>12 months from completion of therapy.
3. Prior neoadjuvant/adjuvant immune checkpoint inhibitor therapy with recurrence \>12 months from completion of therapy.
* Cohort 2: Previously Treated: Participants must have received ≥ 1 prior systemic treatment for locally advanced or metastatic UC. This includes neoadjuvant/adjuvant platinum-based chemotherapy if recurrence occurred within 12 months of completing therapy.
* Cohort 2: Progression or recurrence of UC during or following receipt of most recent therapy.
Exclusion Criteria
* Requirement, while on study, for treatment with strong inhibitors or strong inducers of human cytochrome P450 3A (CYP3A) or inhibitors of P-glycoprotein (P-gp) including herbal- or food-based inhibitors.
* Any condition requiring current treatment with high dose corticosteroids (\> 10 mg daily prednisone or equivalent).
* Known hypersensitivity or allergy to any of the ingredients of any of the study interventions, or to MMAE.
* Has not adequately recovered from recent major surgery (excluding placement of vascular access).
* Receipt of live or attenuated vaccine within 30 days of first dose.
* Cohort 1: Previously Untreated: Prior treatment with a checkpoint inhibitor (CPI) for any other malignancy within the last 12 months.
* Cohort 2: Previously Treated: Received more than 1 prior platinum-based chemotherapy regimen for locally advanced or metastatic UC. This includes neoadjuvant/adjuvant platinum-based chemotherapy if recurrence occurred within 12 months of completing therapy.
* Cohort 2: Prior treatment with enfortumab vedotin or any other MMAE-based therapy
18 Years
ALL
No
Sponsors
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BicycleTx Limited
INDUSTRY
Responsible Party
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Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Virginia K. Crosson Cancer Center at St. Jude Medical Center
Fullerton, California, United States
University of California - Irvine Medical Center
Orange, California, United States
University of California, San Francisco (UCSF)
San Francisco, California, United States
Adventist Health St. Helena
St. Helena, California, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
Yale University School of Medicine - Yale Cancer Center
New Haven, Connecticut, United States
Medical Oncology Hematology Consultants
Newark, Delaware, United States
Cancer Specialists of North Florida
Jacksonville, Florida, United States
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States
AP Medical Research
Miami, Florida, United States
Mount Sinai Medical Center of Florida, Inc.
Miami Beach, Florida, United States
Moffitt
Tampa, Florida, United States
Southern Illinois University (SIU) - Simmons Cancer Institute
Springfield, Illinois, United States
Mission Cancer + Blood
Des Moines, Iowa, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
UofL Health Brown Cancer Center
Louisville, Kentucky, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Corewell Health
Grand Rapids, Michigan, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
XCancer Omaha/Urology Cancer Center
Omaha, Nebraska, United States
Astera Cancer Care
East Brunswick, New Jersey, United States
Summit Health (New Jersey Urology)
Voorhees Township, New Jersey, United States
Columbia University Irving Medical Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Medical University of South Carolina (MUSC) - Hollings Cancer Center
Charleston, South Carolina, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Centro de Diagnostico Urologico S.R.L.
Buenos Aires, , Argentina
Hospital Britanico de Buenos Aires
Buenos Aires, , Argentina
Hospital Sirio Libanes de Buenos Aires
Buenos Aires, , Argentina
Instituto Alexander Fleming
Buenos Aires, , Argentina
Fundacion Medica Rio Negro y Neuquen
Cipolletti, , Argentina
Centro Medico Privado (CEMAIC)
Córdoba, , Argentina
Fundación CORI para la investigación y Prevención del Cancer
La Rioja, , Argentina
Centro De Investigacion Pergamino S.A.
Pergamino, , Argentina
Instituto de Oncologia de Rosario
Santa Fe, , Argentina
Clinica Viedma S.A.
Viedma, , Argentina
Cancer Research SA
Adelaide, , Australia
Mater Misericordiae Ltd, South Brisbane
Brisbane, , Australia
Townsville Hospital and Health Service
Douglas, , Australia
Barwon Health
Geelong, , Australia
Calvary Mater Newcastle
Hunter, , Australia
Sir Charles Gairdner Hospital
Nedlands, , Australia
Blacktown Hospital
New South Wales, , Australia
Prince of Wales Hospital
Randwick, , Australia
Icon Cancer Centre
South Brisbane, , Australia
Gold Coast University Hospital
Southport, , Australia
Princess Alexandra Hospital
Woolloongabba, , Australia
Urologie und Andrologie Ordensklinikum Linz GmbH Elisabethinen
Linz, , Austria
Krankenhaus der Barmherzigen Brüder Wien
Vienna, , Austria
Medizinische Universitaet Wien
Vienna, , Austria
ASBL Grand Hôpital de Charleroi (GHdC), Site Notre Dame
Charleroi, , Belgium
General Hospital Maria Middelares
Ghent, , Belgium
University Hospital Gent
Ghent, , Belgium
Universitaire Ziekenhuizen Leuven
Leuven, , Belgium
Fundacao PIO XII - Hospital de Amor
Barretos, , Brazil
CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina
Florianópolis, , Brazil
Oncosite - Centro de Pesquisa Clinica Em Oncologia
Ijuí, , Brazil
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa
Porto Alegre, , Brazil
Hospital Sao Lucas - Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS)
Porto Alegre, , Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, , Brazil
Hospital A.C. Camargo Cancer Center
São Paulo, , Brazil
British Columbia Cancer Agency- Centre for the Southern Interior
Kelowna, , Canada
McGill University Health Center
Québec, , Canada
Princess Margaret Hospital
Toronto, , Canada
Cancer Care Manitoba
Winnipeg, , Canada
Fundación Arturo López Pérez (FALP)
Santiago, , Chile
Centro de Investigacion Clinica Bradford Hill
Santiago, , Chile
Oncocentro APYS
Viña del Mar, , Chile
Aalborg University Hospital
Aalborg, , Denmark
Service d'Oncologie Medicale - CHRU Besancon
Besançon, , France
CHU Bordeaux - Hopital Saint-Andre
Bordeaux, , France
Institut Bergonie
Bordeaux, , France
Groupement de Cooperation Sanitaire (GCS) ELSAN - Clinique Victor Hugo
Le Mans, , France
CHU de Limoges - Hopital Dupuytren 1
Limoges, , France
Centre Leon Berard
Lyon, , France
Institut Paoli-Calmettes
Marseille, , France
ICM - Institut Regional du Cancer de Montpellier
Montpellier, , France
Centre d'Oncologie de Gentilly
Nancy, , France
Centre Antoine-Lacassagne
Nice, , France
Institut Mutualiste Montsouris
Paris, , France
AP-HP Hopital Europeen Georges Pompidou
Paris, , France
HCL Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU Poitiers - Pole Regional de Cancerologie de Poitiers (PRC)
Poitiers, , France
Institut Gustave Roussy
Villejuif, , France
LTD High Technology Hospital Medcenter
Batumi, , Georgia
The First University Clinic of Tbilisi State Medical University
Tbilisi, , Georgia
New Vision University Hospital
Tbilisi, , Georgia
Multiprofile Clinic Consilium Medulla LTD
Tbilisi, , Georgia
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Krankenhaus Nordwest GmbH
Frankfurt, , Germany
Universitaetsklinikum Frankfurt - Klinikum der Johann Wolfgang Goethe Universitaet
Frankfurt, , Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, , Germany
Georg-August-Universitaet Goettingen Stiftung oeffentlichen Rechts Universitaetsmedizin Goettingen
Göttingen, , Germany
Marien Hospital Herne - Universitaetsklinikum der Ruhr-Universitaet Bochum
Herne, , Germany
Universitaetsmedizin Mannheim
Mannheim, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
Studienpraxis Urologie
Nürtingen, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Orszagos Onkologiai Intezet
Budapest, , Hungary
Budapesti Uzsoki Utcai Korhaz
Budapest, , Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár, , Hungary
Bacs-Kiskun Varmegyei Oktatokorhaz
Kecskemét, , Hungary
Shamir Medical Center
Be’er Ya‘aqov, , Israel
Rambam Health Care Campus
Haifa, , Israel
Hadassah Hebrew University Medical Center
Jerusalem, , Israel
Meir Medical Center
Kfar Saba, , Israel
Rabin Medical Center - Beilinson Hospital
Petah Tikva, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
Centro Riferimento Oncologico - Aviano
Aviano, , Italy
Ospedale Policlinico San Martino IRCCS
Genova, , Italy
Istituto Europeo di Oncologia
Milan, , Italy
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
Napoli, , Italy
Azienda Ospedaliera Santa Maria di Terni
Terni, , Italy
Copernicus PL Sp. z o.o., Wojewodzkie Centrum Onkologii
Gdansk, , Poland
Spitale Pomorskie Sp.z.o.o ODDZIAL ONKOLOGII KLINICZNEJ
Gdynia, , Poland
SCM Sp. z o.o.
Krakow, , Poland
Mazowiecki Szpital Onkologiczny
Wieliszew, , Poland
University Clinical Center of Serbia, Clinic of Urology
Belgrade, , Serbia
National University Hospital
Singapore, , Singapore
National Cancer Centre Singapore
Singapore, , Singapore
Chungnam National University Hospital
Daejeon, , South Korea
National Cancer Center
Goyang, , South Korea
Chonnam National University Hwasun Hospital
Gwangju, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Clinic Barcelona
Barcelona, , Spain
Institut Catala d'Oncologia - L'Hospitalet
Barcelona, , Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Clinica Universidad de Navarra - Madrid
Madrid, , Spain
Hospital Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Clinica Universidad de Navarra - Pamplona
Pamplona, , Spain
Hospital Universitario Donostia
San Sebastián, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, , Spain
Instituto Valenciano de Oncologia
Valencia, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
Chi Mei Medical Center
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital (CGMHLK)
Taoyuan, , Taiwan
Liv Hospital Ankara
Ankara, , Turkey (Türkiye)
Trakya University Medical Faculty
Edirne, , Turkey (Türkiye)
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul, , Turkey (Türkiye)
Istinye Universitesi VM Medical Park Pendik Hastanesi
Istanbul, , Turkey (Türkiye)
Medical Point Izmir Hospital
Izmir, , Turkey (Türkiye)
Kocaeli University Faculty of Medicine
Kocaeli, , Turkey (Türkiye)
Bristol Haematology and Oncology Centre
Bristol, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
St. Bartholomew's Hospital
London, , United Kingdom
University College London Hospital
London, , United Kingdom
Royal Free London NHS Foundation Trust
London, , United Kingdom
Charing Cross Hospital
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
The Royal Marsden Hospital
Sutton, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2023-504231-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1300-3791
Identifier Type: OTHER
Identifier Source: secondary_id
BT8009-230
Identifier Type: -
Identifier Source: org_study_id