Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)
Public ClinicalTrials.gov record NCT06225596. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT06225596
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 375 participants
Conditions and interventions
Conditions
Interventions
- Zelenectide pevedotin Drug
- Pembrolizumab Drug
- Gemcitabine + cisplatin Or carboplatin Drug
- Avelumab Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 23, 2024
- Primary completion
- Feb 29, 2028
- Completion
- Feb 29, 2028
- Last update posted
- May 26, 2026
2024 – 2028
United States locations
- U.S. sites
- 13
- U.S. states
- 9
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Rocky Mountain Cancer Center | Denver | Colorado | 80218 | — |
| University of Miami - Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | — |
| Mount Sinai Medical Center of Florida, Inc. | Miami Beach | Florida | 33140 | — |
| Moffitt | Tampa | Florida | 33612 | — |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | — |
| UofL Health Brown Cancer Center | Louisville | Kentucky | 40202 | — |
| Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | — |
| Montefiore Medical Center | The Bronx | New York | 10461 | — |
| Medical University of South Carolina (MUSC) - Hollings Cancer Center | Charleston | South Carolina | 29425 | — |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | — |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 89 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06225596, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 26, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06225596 live on ClinicalTrials.gov.