A Randomized Open-Label Phase II/III Study of BT8009 as Monotherapy or in Combination in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)
Study Identifier:
BT8009-230
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
Study Contact Information:
Recruitment Complete
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Study Summary
To measure the efficacy and safety of BT8009 as monotherapy and in combination with pembrolizumab in participants with locally advanced or metastatic urothelial cancer (UC). To evaluate the safety and efficacy of BT8009 as monotherapy, or combined with pembrolizumab (pembro), vs chemotherapy in pts with locally advanced or metastatic UC (la/mUC) To evaluate zelenectide pevedotin plus pembrolizumab versus chemotherapy in first-line mUC (Cohort 1), and zelenectide pevedotin monotherapy and in combination with pembrolizumab in late-line mUC (Cohort 2). In each cohort, two doses of zelenectide pevedotin – 5 mg/m2 weekly and 6 mg/m2 two weeks on, one week off – are being initially assessed To evaluate the safety and efficacy of zele as monotherapy, or combined with pembrolizumab (pembro), vs chemotherapy in pts with la/mUC.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
II/III
Sex
Female & Male
Age
18+ years
Study Drug
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Study Status
Indicates the current recruitment status or the expanded access status
Recruitment Complete
Requirements information
Inclusion criteria
- - 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 muscle-invasive UC or locally advanced 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.
- - Cohort 1: Participants must not have received prior systemic therapy for locally
- advanced or metastatic UC with the following exceptions:
- 1. 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.
- 2. Prior neoadjuvant/adjuvant chemotherapy or monomethyl auristatin E (MMAE)-based
- therapy with recurrence >12 months from completion of therapy.
- 3. 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.
- Pts must have la/mUC of the renal pelvis, ureter, bladder, or urethra, ECOG performance status ≤2 (Cohort 1) or ≤1 (Cohort 2), and adequate organ function.
- Cohort 1 will include n≤641 previously untreated pts eligible for platinum-based chemotherapy. Cohort 2 will include n≤315 pts with ≥1 prior systemic therapy, excluding enfortumab vedotin or other MMAE-based therapy.
Exclusion criteria
- - Active keratitis or corneal ulcerations.
- - Requirement, while on study, 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.
- - 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
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Carolinas
Myrtle Beach, SC, United States, 29572
Investigator
Neal Shore
Status
Recruiting
Condition(s) Treated at Site
Urinary tract