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

A Randomized Open-Label Phase 2/3 Study of BT8009 as Monotherapy or in Combination in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)

This is a global, multicenter, randomized, open-label study. The main objective of the study is to measure the clinical activity and safety of zelenectide pevedotin formally BT8009, in combination with pembrolizumab versus chemotherapy, and as monotherapy in participants with locally advanced or metastatic urothelial cancer (UC). The study includes a dose selection for zelenectide pevedotin and is comprised of 2 cohorts. Cohort 1 will include participants who have not received any prior systemic therapy for locally advanced or metastatic UC and are eligible to receive platinum-based chemotherapy, whereas Cohort 2 will include participants who have received ≥ 1 prior systemic therapy for locally advanced or metastatic UC.

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Urothelial Cancer
• Intervention / Treatment: Drug: Gemcitabine + cisplatin Or carboplatin; Drug: Avelumab; Drug: Zelenectide pevedotin; Drug: Zelenectide pevedotin; Drug: Pembrolizumab

• Study Type: Interventional
• Enrollment (Estimated): 375
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1426ANZ
    • Instituto Alexander Fleming
  • Buenos Aires, Argentina, C1280AEB
    • Hospital Britanico de Buenos Aires
  • Buenos Aires, Argentina, C1120AAT
    • Centro de Diagnostico Urologico S.R.L.
  • Buenos Aires, Argentina, C1419AHN
    • Hospital Sirio Libanes de Buenos Aires
  • Cipolletti, Argentina, R8324
    • Fundacion Medica Rio Negro y Neuquen
  • Córdoba, Argentina, X5008HHW
    • Centro Medico Privado (CEMAIC)
  • La Rioja, Argentina, 5300
    • Fundación CORI para la investigación y Prevención del Cancer
  • Pergamino, Argentina, B2700CPM
    • Centro de Investigacion Pergamino S.A.
  • Santa Fe, Argentina, S2000KZE
    • Instituto de Oncologia de Rosario
  • Viedma, Argentina, 8500
    • Clinica Viedma S.A.
• Australia
  • Adelaide, Australia, 5000
    • Cancer Research SA
  • Brisbane, Australia, 4101
    • Mater Misericordiae Ltd, South Brisbane
  • Douglas, Australia, QLD 4814
    • Townsville Hospital and Health Service
  • Geelong, Australia, 3220
    • Barwon Health
  • Hunter, Australia, 2310
    • Calvary Mater Newcastle
  • Nedlands, Australia, 6009
    • Sir Charles Gairdner Hospital
  • New South Wales, Australia, 2148
    • Blacktown Hospital
  • South Brisbane, Australia, 4066
    • Icon Cancer Centre
  • Southport, Australia, 4215
    • Gold Coast University Hospital
• Belgium
  • Ghent, Belgium, 9000
    • General Hospital Maria Middelares
  • Ghent, Belgium, 9000
    • University Hospital Gent
• Brazil
  • Barretos, Brazil, 14784-400
    • Fundacao PIO XII - Hospital de Amor
  • Florianópolis, Brazil, 88020-210
    • CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina
  • São Paulo, Brazil, 01327-001
    • Hospital Alemao Oswaldo Cruz
• Canada
  • Québec, Canada, H4A 3J1
    • McGill University Health Center
  • Toronto, Canada, M5G 2M9
    • Princess Margaret Hospital
• Chile
  • Santiago, Chile, 7500921
    • Fundación Arturo López Pérez (FALP)
  • Santiago, Chile, 8420000
    • Centro de Investigacion Clinica Bradford Hill
  • Viña del Mar, Chile, 2520598
    • Oncocentro APYS
• France
  • Besançon, France, 25000
    • Service d'Oncologie Medicale - CHRU Besancon
  • Bordeaux, France, 33000
    • CHU Bordeaux - Hopital Saint-Andre
  • Le Mans, France, 72000
    • Groupement de Cooperation Sanitaire (GCS) ELSAN - Clinique Victor Hugo
  • Pierre-Bénite, France, 69495
    • HCL Centre Hospitalier Lyon Sud
  • Villejuif, France, 94805
    • Institut Gustave Roussy
• Georgia
  • Batumi, Georgia, 6000
    • LTD High Technology Hospital Medcenter
  • Tbilisi, Georgia, 0141
    • The First University Clinic of Tbilisi State Medical University
  • Tbilisi, Georgia, 0159
    • New Vision University Hospital
  • Tbilisi, Georgia, 0186
    • Multiprofile Clinic Consilium Medulla LTD
• Germany
  • Essen, Germany, 45147
    • Universitaetsklinikum Essen
• Hungary
  • Budapest, Hungary, H-1122
    • Országos Onkológiai Intézet
  • Budapest, Hungary, H-1145
    • Budapesti Uzsoki Utcai Korhaz
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus
  • Jerusalem, Israel, 9112001
    • Hadassah Hebrew University Medical Center
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center - Beilinson Hospital
• Italy
  • Aviano, Italy, 33081
    • Centro Riferimento Oncologico - Aviano
  • Genova, Italy, 16132
    • Ospedale Policlinico San Martino IRCCS
  • Naples, Italy, 80131
    • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
• Poland
  • Gdansk, Poland, 80-210
    • Copernicus PL Sp. z o.o., Wojewodzkie Centrum Onkologii
  • Wieliszew, Poland, 05-135
    • Mazowiecki Szpital Onkologiczny
• Serbia
  • Belgrade, Serbia, 11000
    • University Clinical Center of Serbia, Clinic of Urology
• Singapore
  • Singapore, Singapore, 119228
    • National University Hospital
• South Korea
  • Daejeon, South Korea, 35015
    • Chungnam National University Hospital
  • Goyang, South Korea, 10408
    • National Cancer Center
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 02841
    • Korea University Anam Hospital
  • Seoul, South Korea, 3722
    • Severance Hospital, Yonsei University Health System
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic Barcelona
  • Barcelona, Spain, 08026
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 08908
    • Institut Catala d'Oncologia - L'Hospitalet
  • Las Palmas de Gran Canaria, Spain, 35016
    • Hospital Universitario Insular de Gran Canaria
  • Madrid, Spain, 28027
    • Clínica Universidad de Navarra - Madrid
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañón
  • Madrid, Spain, 28040
    • Hospital Fundación Jiménez Díaz
  • Pamplona, Spain, 31008
    • Clinica Universidad de Navarra - Pamplona
  • San Sebastián, Spain, 20014
    • Hospital Universitario Donostia
  • Santander, Spain, 39008
    • Hospital Universitario Marques de Valdecilla
  • Santiago de Compostela, Spain, 15706
    • Hospital Clinico Universitario de Santiago
  • Valencia, Spain, 46009
    • Instituto Valenciano de Oncologia
• Taiwan
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Tainan, Taiwan, 710
    • Chi Mei Medical Center
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taoyuan City, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital (CGMHLK)
• Turkey (Türkiye)
  • Edirne, Turkey (Türkiye), 22030
    • Trakya University Medical Faculty
  • Istanbul, Turkey (Türkiye), 34899
    • Istinye Universitesi VM Medical Park Pendik Hastanesi
  • Izmir, Turkey (Türkiye), 35575
    • Medical Point Izmir Hospital
  • Kocaeli, Turkey (Türkiye), 41380
    • Kocaeli University Faculty of Medicine
• United Kingdom
  • Bristol, United Kingdom, BS2 8ED
    • Bristol Haematology and Oncology Centre
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrooke's Hospital
  • London, United Kingdom, NW3 2QG
    • Royal Free London NHS Foundation Trust
  • London, United Kingdom, EC1A 7BE
    • St. Bartholomew's Hospital
  • London, United Kingdom, NW1 2PG
    • University College London Hospital
  • Plymouth, United Kingdom, PL6 8DH
    • Derriford Hospital
  • Sutton, United Kingdom, SM2 5PT
    • The Royal Marsden hospital
• United States
  • Colorado
    • Denver, Colorado, United States, 80218
      • Rocky Mountain Cancer Center
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami - Sylvester Comprehensive Cancer Center
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Medical Center of Florida, Inc.
    • Tampa, Florida, United States, 33612
      • Moffitt
  • Kansas
    • Westwood, Kansas, United States, 66205
      • University of Kansas Cancer Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • UofL Health Brown Cancer Center
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • Nebraska Cancer Specialists
  • New York
    • The Bronx, New York, United States, 10461
      • Montefiore Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina (MUSC) - Hollings Cancer Center
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • SCRI Oncology Partners
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center at San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Life expectancy ≥ 12 weeks.
• 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 primary 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.

Key Exclusion Criteria:

• Active keratitis or corneal ulcerations.
• Requirement, while receiving study medications, 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cohort 1: Arm 3; Participants will receive Platinum-based combination chemotherapy +/- avelumab maintenance	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.
Experimental: Cohort 1: Zelenectide pevedotin Arm 1; Participants will receive zelenectide pevedotin and a standard dose of pembrolizumab.	Drug: Zelenectide pevedotin; Participants will receive zelenectide pevedotin on Days 1, 8, and 15 of every 21-day cycle.; Other Names: BT8009; Drug: Zelenectide pevedotin; Participants will receive zelenectide pevedotin on Days 1 and 8 of every 21-day cycle.; Other Names: BT8009; 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 zelenectide pevedotin infusion.
Experimental: Cohort 1: Zelenectide pevedotin Arm 2; Participants will receive zelenectide pevedotin and a standard dose of pembrolizumab.	Drug: Zelenectide pevedotin; Participants will receive zelenectide pevedotin on Days 1, 8, and 15 of every 21-day cycle.; Other Names: BT8009; Drug: Zelenectide pevedotin; Participants will receive zelenectide pevedotin on Days 1 and 8 of every 21-day cycle.; Other Names: BT8009; 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 zelenectide pevedotin infusion.
Experimental: Cohort 2: Zelenectide pevedotin Arm 1; Participants will receive zelenectide pevedotin.	Drug: Zelenectide pevedotin; Participants will receive zelenectide pevedotin on Days 1, 8, and 15 of every 21-day cycle.; Other Names: BT8009; Drug: Zelenectide pevedotin; Participants will receive zelenectide pevedotin on Days 1 and 8 of every 21-day cycle.; Other Names: BT8009
Experimental: Cohort 2: Zelenectide pevedotin Arm 2; Participants will receive zelenectide pevedotin.	Drug: Zelenectide pevedotin; Participants will receive zelenectide pevedotin on Days 1, 8, and 15 of every 21-day cycle.; Other Names: BT8009; Drug: Zelenectide pevedotin; Participants will receive zelenectide pevedotin on Days 1 and 8 of every 21-day cycle.; Other Names: BT8009

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort 1: Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors, version 1.1(RECIST v1.1) by blinded central independent review (BICR) of optimal dose zelenectide pevedotin with pembrolizumab versus chemotherapy	The time from randomization to date of first documentation of disease progression or death.	Up to approximately 4 years
Cohort 2: PFS per RECIST v1.1 assessed by BICR of zelenectide pevedotin monotherapy in each treatment regimen	The time from randomization to date of first documentation of disease progression or death.	Up to approximately 4 years
Cohort 2: Objective response rate (ORR) per RECIST v1.1 assessed by BICR of zelenectide pevedotin monotherapy in each treatment regimen		Up to approximately 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort 1: PFS per RECIST v1.1 assessed by BICR of zelenectide pevedotin combined treatment arms versus chemotherapy	The time from randomization to date of first documentation of disease progression or death.	Up to approximately 4 years
Cohort 1: ORR per RECIST v1.1 assessed by BICR of optimal dose zelenectide pevedotin in combination with pembrolizumab versus chemotherapy.		Up to approximately 4 years
Cohort 1: ORR per RECIST v1.1 assessed by BICR of zelenectide pevedotin combined treatment arms versus chemotherapy		Up to approximately 4 years
Cohort 1: Overall survival (OS) rate of optimal dose zelenectide pevedotin in combination with pembrolizumab versus chemotherapy	The time from randomization to date of death from any cause.	Up to approximately 4 years
Cohort 1: Duration of response (DoR) per RECIST v1.1 assessed by BICR of optimal dose of zelenectide pevedotin in combination with pembrolizumab	The time from time of first documentation of objective response that is subsequently confirmed to date of first documentation of disease progression or death.	Up to approximately 4 years
Cohort 1: Disease control rate (DCR) per RECIST v1.1 assessed by BICR of optimal dose of zelenectide pevedotin in combination with pembrolizumab	The time from randomization to date of first documentation of disease progression or death.	Up to approximately 4 years
Cohort 1: PFS per RECIST v1.1 assessed by BICR of unselected zelenectide pevedotin dose in combination with pembrolizumab	The time from randomization to date of first documentation of disease progression or death.	Up to approximately 4 years
Cohort 1: OS rate of zelenectide pevedotin combined treatment arms in combination with pembrolizumab versus chemotherapy	The time from randomization to date of death from any cause	Up to approximately 4 years
Cohort 2: DoR per RECIST v1.1 assessed by BICR in each treatment regimen	The time from time of first documentation of objective response that is subsequently confirmed to date of first documentation of disease progression or death.	Up to approximately 4 years
Cohort 2: DCR per RECIST v1.1 assessed by BICR in each treatment regimen	The time from cycle 1 Day 1 to date of first documentation of disease progression or death	Up to approximately 4 years
Cohort 2: OS rate in each treatment regimen	The time from randomization to date of death from any cause	Up to approximately 4 years
Cohorts 1 and 2: Safety and tolerability of each treatment regimen	Safety will be reported as incidence, severity, seriousness, relationship to study and types of adverse events	Until 30 days post last dose, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for zelenectide pevedotin area under the plasma concentration-time curve (AUC)	Quantitative modeling of the association between measured zelenectide pevedotin pharmacokinetic (PK) parameter (AUC) and ORR.	Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for zelenectide pevedotin AUC	Quantitative modeling of the association between measured zelenectide pevedotin PK parameter (AUC) and PFS.	Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for monomethyl auristatin (MMAE) AUC	Quantitative modeling of the association between measured MMAE PK parameter (AUC) and ORR.	Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for MMAE AUC	Quantitative modeling of the association between measured MMAE PK parameter (AUC) and PFS.	Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for zelenectide pevedotin maximum plasma concentration (Cmax)	Quantitative modeling of the association between measured zelenectide pevedotin PK parameter (Cmax) and ORR.	Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for zelenectide pevedotin Cmax	Quantitative modeling of the association between measured zelenectide pevedotin PK parameter (Cmax) and PFS.	Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for MMAE Cmax	Quantitative modeling of the association between measured MMAE PK parameter (Cmax) and ORR.	Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for MMAE Cmax	Quantitative modeling of the association between measured MMAE PK parameter (Cmax) and PFS.	Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for zelenectide pevedotin average plasma concentration (Cavg)	Quantitative modeling of the association between measured zelenectide pevedotin PK parameter (Cavg) and ORR.	Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for zelenectide pevedotin Cavg	Quantitative modeling of the association between measured zelenectide pevedotin PK parameter (Cavg) and PFS.	Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for MMAE Cavg	Quantitative modeling of the association between measured MMAE PK parameter (Cavg) and ORR.	Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-efficacy relationships for MMAE Cavg	Quantitative modeling of the association between measured MMAE PK parameter (Cavg) and PFS.	Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-safety relationships for zelenectide pevedotin AUC	Quantitative modeling of the association between measured zelenectide pevedotin PK parameter (AUC) and clinical safety, measured by incidence of most frequent or relevant treatment emergent adverse events and treatment related adverse events	Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-safety relationships for MMAE AUC	Quantitative modeling of the association between measured MMAE PK parameter (AUC) and clinical safety, measured by incidence of most frequent or relevant treatment emergent adverse events and treatment related adverse events.	Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-safety relationships for zelenectide pevedotin Cmax	Quantitative modeling of the association between measured zelenectide pevedotin PK parameter (Cmax) and clinical safety, measured by incidence of most frequent or relevant treatment emergent adverse events and treatment related adverse events.	Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-safety relationships for MMAE Cmax	Quantitative modeling of the association between measured MMAE PK parameter (Cmax) and clinical safety, measured by incidence of most frequent or relevant treatment emergent adverse events and treatment related adverse events.	Until the end of treatment, up to approximately 4 years
Cohorts 1 and 2: Exposure-safety relationships for zelenectide pevedotin Cavg	Quantitative modeling of the association between measured zelenectide pevedotin PK parameter (Cavg) and clinical safety, measured by incidence of most frequent or relevant treatment emergent adverse events and treatment related adverse events.	Until the end of treatment, up to approximately 4 years
Exposure-safety relationships for MMAE Cavg	Quantitative modeling of the association between measured MMAE PK parameter (Cavg) and clinical safety, measured by incidence of most frequent or relevant treatment emergent adverse events and treatment related adverse events.	Until the end of treatment, up to approximately 4 years

Collaborators and Investigators

• Sponsor: BicycleTx Limited

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Actual): January 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Bladder cancer; Avelumab; Pembrolizumab; Chemotherapy; Metastatic Urothelial Cancer; BT8009; Zelenectide pevedotin
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Platinum Compounds; Gemcitabine; Carboplatin; Cisplatin; pembrolizumab; avelumab
• Other Study ID Numbers: BT8009-230; 2023-504231-41 (EudraCT Number); U1111-1300-3791 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No