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Metastatic Urothelial CancerPhase 2NCT06225596

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

A Phase 2 study testing Zelenectide pevedotin, Pembrolizumab and Gemcitabine + cisplatin Or carboplatin in people with Metastatic Urothelial Cancer, run by BicycleTx Limited at 102 sites in 21 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Urothelial Cancer
What is being tested?
Zelenectide pevedotin, Pembrolizumab and Gemcitabine + cisplatin Or carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
375 participants
Where
102 sitesin 21 countries
Study dates
24 Jan 2024to Mar 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • Cohort 1: Participants must not have received prior systemic therapy for locally advanced or metastatic UC with the following exceptions:
  • 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.
  • Prior neoadjuvant/adjuvant chemotherapy or monomethyl auristatin E (MMAE)-based therapy with recurrence >12 months from completion of therapy.
  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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

Trial locations and contacts

102 sites in 21 countries.

102 sites in 21 countries

Spain14 sites

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08026

  • Hospital Clinic Barcelona

    Barcelona, 08036

  • Institut Catala d'Oncologia - L'Hospitalet

    Barcelona, 08908

  • Hospital Universitario Insular de Gran Canaria

    Las Palmas de Gran Canaria, 35016

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Clinica Universidad de Navarra - Madrid

    Madrid, 28027

  • Hospital Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Clinica Universidad de Navarra - Pamplona

    Pamplona, 31008

  • Hospital Universitario Donostia

    San Sebastián, 20014

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, 15706

  • Instituto Valenciano de Oncologia

    Valencia, 46009

Other trials in Spain

United States13 sites

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

    Charleston, South Carolina, 29425

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • UofL Health Brown Cancer Center

    Louisville, Kentucky, 40202

  • University of Miami - Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Mount Sinai Medical Center of Florida, Inc.

    Miami Beach, Florida, 33140

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Moffitt

    Tampa, Florida, 33612

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

Other trials in United States

Argentina10 sites

  • Centro de Diagnostico Urologico S.R.L.

    Buenos Aires, C1120AAT

  • Hospital Britanico de Buenos Aires

    Buenos Aires, C1280AEB

  • Hospital Sirio Libanes de Buenos Aires

    Buenos Aires, C1419AHN

  • Instituto Alexander Fleming

    Buenos Aires, C1426ANZ

  • Fundacion Medica Rio Negro y Neuquen

    Cipolletti, R8324

  • Centro Medico Privado (CEMAIC)

    Córdoba, X5008HHW

  • Fundación CORI para la investigación y Prevención del Cancer

    La Rioja, 5300

  • Centro De Investigacion Pergamino S.A.

    Pergamino, B2700CPM

  • Instituto de Oncologia de Rosario

    Santa Fe, S2000KZE

  • Clinica Viedma S.A.

    Viedma, 8500

Other trials in Argentina

Australia9 sites

  • Cancer Research SA

    Adelaide, 5000

  • Mater Misericordiae Ltd, South Brisbane

    Brisbane, 4101

  • Townsville Hospital and Health Service

    Douglas, QLD 4814

  • Barwon Health

    Geelong, 3220

  • Calvary Mater Newcastle

    Hunter, 2310

  • Sir Charles Gairdner Hospital

    Nedlands, 6009

  • Blacktown Hospital

    New South Wales, 2148

  • Icon Cancer Centre

    South Brisbane, 4066

  • Gold Coast University Hospital

    Southport, 4215

Other trials in Australia

South Korea7 sites

  • Chungnam National University Hospital

    Daejeon, 35015

  • National Cancer Center

    Goyang, 10408

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Severance Hospital, Yonsei University Health System

    Seoul, 3722

Other trials in South Korea

United Kingdom7 sites

  • Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

  • St. Bartholomew's Hospital

    London, EC1A 7BE

  • University College London Hospital

    London, NW1 2PG

  • Royal Free London NHS Foundation Trust

    London, NW3 2QG

  • Derriford Hospital

    Plymouth, PL6 8DH

  • The Royal Marsden Hospital

    Sutton, SM2 5PT

Other trials in United Kingdom

Taiwan6 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • China Medical University Hospital

    Taichung, 40447

  • National Cheng Kung University Hospital

    Tainan, 704

  • Chi Mei Medical Center

    Tainan, 710

  • National Taiwan University Hospital

    Taipei, 10002

  • Linkou Chang Gung Memorial Hospital (CGMHLK)

    Taoyuan City, 333

Other trials in Taiwan

France5 sites

  • Service d'Oncologie Medicale - CHRU Besancon

    Besançon, 25000

  • CHU Bordeaux - Hopital Saint-Andre

    Bordeaux, 33000

  • Groupement de Cooperation Sanitaire (GCS) ELSAN - Clinique Victor Hugo

    Le Mans, 72000

  • HCL Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Georgia4 sites

  • LTD High Technology Hospital Medcenter

    Batumi, 6000

  • The First University Clinic of Tbilisi State Medical University

    Tbilisi, 0141

  • New Vision University Hospital

    Tbilisi, 0159

  • Multiprofile Clinic Consilium Medulla LTD

    Tbilisi, 0186

Other trials in Georgia

Turkey (Türkiye)4 sites

  • Trakya University Medical Faculty

    Edirne, 22030

  • Istinye Universitesi VM Medical Park Pendik Hastanesi

    Istanbul, 34899

  • Medical Point Izmir Hospital

    Izmir, 35575

  • Kocaeli University Faculty of Medicine

    Kocaeli, 41380

Other trials in Turkey (Türkiye)

Brazil3 sites

  • Fundacao PIO XII - Hospital de Amor

    Barretos, 14784-400

  • CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina

    Florianópolis, 88020-210

  • Hospital Alemao Oswaldo Cruz

    São Paulo, 01327-001

Other trials in Brazil

Chile3 sites

  • Fundación Arturo López Pérez (FALP)

    Santiago, 7500921

  • Centro de Investigacion Clinica Bradford Hill

    Santiago, 8420000

  • Oncocentro APYS

    Viña del Mar, 2520598

Other trials in Chile

Israel3 sites

  • Rambam Health Care Campus

    Haifa, 3109601

  • Hadassah Hebrew University Medical Center

    Jerusalem, 9112001

  • Rabin Medical Center - Beilinson Hospital

    Petah Tikva, 4941492

Other trials in Israel

Italy3 sites

  • Centro Riferimento Oncologico - Aviano

    Aviano, 33081

  • Ospedale Policlinico San Martino IRCCS

    Genova, 16132

  • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

    Naples, 80131

Other trials in Italy

Belgium2 sites

  • General Hospital Maria Middelares

    Ghent, 9000

  • University Hospital Gent

    Ghent, 9000

Other trials in Belgium

Canada2 sites

  • McGill University Health Center

    Québec, H4A 3J1

  • Princess Margaret Hospital

    Toronto, M5G 2M9

Other trials in Canada

Hungary2 sites

  • Orszagos Onkologiai Intezet

    Budapest, H-1122

  • Budapesti Uzsoki Utcai Korhaz

    Budapest, H-1145

Other trials in Hungary

Poland2 sites

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

    Gdansk, 80-210

  • Mazowiecki Szpital Onkologiczny

    Wieliszew, 05-135

Other trials in Poland

Germany1 site

  • Universitaetsklinikum Essen

    Essen, 45147

Other trials in Germany

Serbia1 site

  • University Clinical Center of Serbia, Clinic of Urology

    Belgrade, 11000

Other trials in Serbia

Singapore1 site

  • National University Hospital

    Singapore, 119228

Other trials in Singapore

About this study

Official title: 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.

Being tested
Zelenectide pevedotin, Pembrolizumab, Gemcitabine + cisplatin Or carboplatin, Avelumab
Keywords
Metastatic Urothelial Cancer, BT8009, Bladder cancer, Pembrolizumab, Chemotherapy, Avelumab, Zelenectide pevedotin
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zelenectide pevedotinDrug

    Also called BT8009

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

  • Zelenectide pevedotinDrug

    Also called BT8009

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

  • PembrolizumabDrug

    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.

  • Gemcitabine + cisplatin Or carboplatinDrug

    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.

  • AvelumabDrug

    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.

Study groups in NCT06225596
Study groupRoleWhat they receive
Cohort 1: Zelenectide pevedotin Arm 1ExperimentalParticipants will receive zelenectide pevedotin and a standard dose of pembrolizumab.
Receives: Drug: Zelenectide pevedotin; Drug: Pembrolizumab
Cohort 1: Zelenectide pevedotin Arm 2ExperimentalParticipants will receive zelenectide pevedotin and a standard dose of pembrolizumab.
Receives: Drug: Zelenectide pevedotin; Drug: Pembrolizumab
Cohort 1: Arm 3Active comparatorParticipants will receive Platinum-based combination chemotherapy +/- avelumab maintenance
Receives: Drug: Gemcitabine + cisplatin Or carboplatin; Drug: Avelumab
Cohort 2: Zelenectide pevedotin Arm 1ExperimentalParticipants will receive zelenectide pevedotin.
Receives: Drug: Zelenectide pevedotin
Cohort 2: Zelenectide pevedotin Arm 2ExperimentalParticipants will receive zelenectide pevedotin.
Receives: Drug: Zelenectide pevedotin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to approximately 4 years

  2. 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.

    Measured: Up to approximately 4 years

  3. Cohort 2: Objective response rate (ORR) per RECIST v1.1 assessed by BICR of zelenectide pevedotin monotherapy in each treatment regimen

    Measured: Up to approximately 4 years

Secondary outcomes (30)

  1. 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.

    Measured: Up to approximately 4 years

  2. Cohort 1: ORR per RECIST v1.1 assessed by BICR of optimal dose zelenectide pevedotin in combination with pembrolizumab versus chemotherapy.

    Measured: Up to approximately 4 years

  3. Cohort 1: ORR per RECIST v1.1 assessed by BICR of zelenectide pevedotin combined treatment arms versus chemotherapy

    Measured: Up to approximately 4 years

  4. 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.

    Measured: Up to approximately 4 years

  5. 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.

    Measured: Up to approximately 4 years

  6. 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.

    Measured: Up to approximately 4 years

  7. 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.

    Measured: Up to approximately 4 years

  8. 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

    Measured: Up to approximately 4 years

  9. 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.

    Measured: Up to approximately 4 years

  10. 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

    Measured: Up to approximately 4 years

  11. Cohort 2: OS rate in each treatment regimen

    The time from randomization to date of death from any cause

    Measured: Up to approximately 4 years

  12. 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

    Measured: Until 30 days post last dose, up to approximately 4 years

  13. 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.

    Measured: Until the end of treatment, up to approximately 4 years

  14. 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.

    Measured: Until the end of treatment, up to approximately 4 years

  15. 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.

    Measured: Until the end of treatment, up to approximately 4 years

  16. Cohorts 1 and 2: Exposure-efficacy relationships for MMAE AUC

    Quantitative modeling of the association between measured MMAE PK parameter (AUC) and PFS.

    Measured: Until the end of treatment, up to approximately 4 years

  17. 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.

    Measured: Until the end of treatment, up to approximately 4 years

  18. 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.

    Measured: Until the end of treatment, up to approximately 4 years

  19. Cohorts 1 and 2: Exposure-efficacy relationships for MMAE Cmax

    Quantitative modeling of the association between measured MMAE PK parameter (Cmax) and ORR.

    Measured: Until the end of treatment, up to approximately 4 years

  20. Cohorts 1 and 2: Exposure-efficacy relationships for MMAE Cmax

    Quantitative modeling of the association between measured MMAE PK parameter (Cmax) and PFS.

    Measured: Until the end of treatment, up to approximately 4 years

  21. 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.

    Measured: Until the end of treatment, up to approximately 4 years

  22. 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.

    Measured: Until the end of treatment, up to approximately 4 years

  23. Cohorts 1 and 2: Exposure-efficacy relationships for MMAE Cavg

    Quantitative modeling of the association between measured MMAE PK parameter (Cavg) and ORR.

    Measured: Until the end of treatment, up to approximately 4 years

  24. Cohorts 1 and 2: Exposure-efficacy relationships for MMAE Cavg

    Quantitative modeling of the association between measured MMAE PK parameter (Cavg) and PFS.

    Measured: Until the end of treatment, up to approximately 4 years

  25. 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

    Measured: Until the end of treatment, up to approximately 4 years

  26. 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.

    Measured: Until the end of treatment, up to approximately 4 years

  27. 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.

    Measured: Until the end of treatment, up to approximately 4 years

  28. 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.

    Measured: Until the end of treatment, up to approximately 4 years

  29. 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.

    Measured: Until the end of treatment, up to approximately 4 years

  30. 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.

    Measured: Until the end of treatment, up to approximately 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2024
  2. Study start24 Jan 2024
  3. Primary completionMar 2028 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
375 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06225596
Sponsor's protocol ID
BT8009-230
Other IDs
2023-504231-41, U1111-1300-3791, 2023
Status last verified
Oct 2026
First submitted
12 Jan 2024
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zelenectide pevedotin, Pembrolizumab and Gemcitabine + cisplatin Or carboplatin in people with Metastatic Urothelial Cancer, run by BicycleTx Limited at 102 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 102 sites in Spain, United States, Argentina, Australia, South Korea and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Up to approximately 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06225596.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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