Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Urinary Bladder Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Carboplatin

Pembrolizumab

Avelumab

Cisplatin

Antimetabolites

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Participants will receive BT8009 and a standard dose of pembrolizumab.

Participants will receive Platinum-based combination chemotherapy +/- avelumab maintenance

Participants will receive BT8009 on Days 1, 8, and 15 of every 21-day cycle.

BT8009

Participants will receive BT8009 on Days 1 and 8 of every 21-day cycle.

Participants will receive BT8009 on days 1, 8 +/- 15 schedule of every 21-day cycle.

Participants will receive Pembrolizumab on Day 1 of every 21-day cycle. Pembrolizumab infusion will be started 30 minutes following the completion of the BT8009 infusion.

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.

Gemcitabine + cisplatin Or carboplatin

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.

BicycleTx Limited

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.

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)

The time from randomization to date of first documentation of disease progression or death.

The time from randomization to date of death from any cause.

The time from time of first documentation of objective response that is subsequently confirmed to date of first documentation of objective tumor progression or death.

The time from Cycle 1 Day 1 to date of first documentation of disease progression or death

Spots Global Cancer Trial Database for gemcitabine + cisplatin or carboplatin