Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
completion around

Description

Summary

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.

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)

Keywords

Metastatic Urothelial Cancer, BT8009, Bladder cancer, Pembrolizumab, Chemotherapy, Avelumab, Zelenectide pevedotin, Carboplatin, Gemcitabine, Gemcitabine + cisplatin Or carboplatin

Eligibility

Locations

  • University of California - Irvine Medical Center accepting new patients
    Orange California 92868 United States
  • Virginia K. Crosson Cancer Center at St. Jude Medical Center accepting new patients
    Fullerton California 92835 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
BicycleTx Limited
ID
NCT06225596
Phase
Phase 2/3 Transitional Cell Carcinoma Research Study
Study Type
Interventional
Participants
Expecting 956 study participants
Last Updated