OncoMatch/Clinical Trials/NCT06225596
Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)
Is NCT06225596 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments for metastatic urothelial cancer.
Treatment: BT8009 · BT8009 · BT8009 · Pembrolizumab · Gemcitabine + cisplatin Or carboplatin · Avelumab — This is a global, multicenter, randomized, open-label study, with an adaptive design. The main objective of the study is to measure the efficacy and safety of BT8009 (zelenectide pevedotin) as monotherapy and in combination with pembrolizumab in participants with locally advanced or metastatic urothelial cancer (UC). The study includes a dose selection phase followed by an adaptive design continuation. The study 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Prior therapy
Must have received: systemic therapy — locally advanced or metastatic UC
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.
Cannot have received: systemic therapy
Exception: local intravesical chemotherapy, local surgery when full resection is not achieved, local immunotherapy, and radiotherapy are permitted if completed at least 4 weeks prior and all acute toxicities have resolved; prior neoadjuvant/adjuvant chemotherapy or MMAE-based therapy with recurrence >12 months from completion; prior neoadjuvant/adjuvant immune checkpoint inhibitor therapy with recurrence >12 months from completion
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.
Cannot have received: checkpoint inhibitor
Cohort 1: Previously Untreated: Prior treatment with a checkpoint inhibitor (CPI) for any other malignancy within the last 12 months.
Cannot have received: platinum-based chemotherapy
Exception: no more than 1 prior regimen for locally advanced or metastatic UC (Cohort 2)
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.
Cannot have received: MMAE-based therapy (enfortumab vedotin)
Cohort 2: Prior treatment with enfortumab vedotin or any other MMAE-based therapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Arkansas for Medical Sciences · Little Rock, Arkansas
- Virginia K. Crosson Cancer Center at St. Jude Medical Center · Fullerton, California
- University of California - Irvine Medical Center · Orange, California
- University of California, San Francisco (UCSF) · San Francisco, California
- Adventist Health St. Helena · St. Helena, California
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