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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06225596
Registration number
NCT06225596
Ethics application status
Date submitted
12/01/2024
Date registered
26/01/2024
Date last updated
11/06/2024
Titles & IDs
Public title
Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)
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Scientific 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)
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Secondary ID [1]
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2023-504231-41
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Secondary ID [2]
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BT8009-230
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Urothelial Cancer
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BT8009
Treatment: Drugs - BT8009
Treatment: Drugs - BT8009
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Gemcitabine + cisplatin Or carboplatin
Treatment: Drugs - Avelumab
Experimental: Cohort 1: BT8009 Arm 1 - Participants will receive BT8009 and a standard dose of pembrolizumab.
Experimental: Cohort 1: BT8009 Arm 2 - Participants will receive BT8009 and a standard dose of pembrolizumab.
Active comparator: Cohort 1: Arm 3 - Participants will receive Platinum-based combination chemotherapy +/- avelumab maintenance
Experimental: Cohort 2: BT8009 Arm 1 - Participants will receive BT8009.
Experimental: Cohort 2: BT8009 Arm 2 - Participants will receive BT8009.
Experimental: Cohort 2: Arm 3: BT8009 (Not Recruiting) - Participants will receive BT8009 and a standard dose of pembrolizumab.
Treatment: Drugs: BT8009
Participants will receive BT8009 on Days 1, 8, and 15 of every 21-day cycle.
Treatment: Drugs: BT8009
Participants will receive BT8009 on Days 1 and 8 of every 21-day cycle.
Treatment: Drugs: BT8009
Participants will receive BT8009 on days 1, 8 +/- 15 schedule of every 21-day cycle.
Treatment: Drugs: Pembrolizumab
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.
Treatment: Drugs: Gemcitabine + cisplatin Or carboplatin
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.
Treatment: Drugs: Avelumab
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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Cohort 1: Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) assessed by blinded central independent review (BICR)
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Assessment method [1]
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The time from randomization to date of first documentation of disease progression or death.
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Timepoint [1]
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Up to approximately 6 years
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Primary outcome [2]
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Cohort 2: Objective response rate (ORR) per RECIST 1.1 assessed by BICR
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Assessment method [2]
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The time from randomization to date of first documentation of disease progression or death.
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Timepoint [2]
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Up to approximately 6 years
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Secondary outcome [1]
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Cohort 1: ORR per RECIST 1.1 assessed by BICR
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Assessment method [1]
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The time from randomization to date of first documentation of disease progression or death.
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Timepoint [1]
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Up to approximately 6 years
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Secondary outcome [2]
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Cohorts 1 and 2: ORR per RECIST 1.1 assessed by Investigator
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Assessment method [2]
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The time from randomization to date of first documentation of disease progression or death.
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Timepoint [2]
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Up to approximately 6 years
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Secondary outcome [3]
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Cohorts 1 and 2: Overall survival (OS) rate
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Assessment method [3]
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The time from randomization to date of death from any cause.
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Timepoint [3]
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Up to approximately 7 years
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Secondary outcome [4]
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Cohorts 1 and 2: Duration of response (DoR) per RECIST 1.1 assessed by BICR
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Assessment method [4]
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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.
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Timepoint [4]
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Up to approximately 6 years
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Secondary outcome [5]
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Cohorts 1 and 2: DoR per RECIST 1.1 assessed by Investigator
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Assessment method [5]
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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.
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Timepoint [5]
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Up to approximately 6 years
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Secondary outcome [6]
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Cohorts 1 and 2: Disease control rate (DCR) per RECIST 1.1 assessed by BICR
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Assessment method [6]
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The time from randomization to date of first documentation of disease progression or death.
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Timepoint [6]
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Up to approximately 6 years
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Secondary outcome [7]
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Cohorts 1 and 2: DCR per RECIST 1.1 assessed by Investigator
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Assessment method [7]
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The time from Cycle 1 Day 1 to date of first documentation of disease progression or death
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Timepoint [7]
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Up to approximately 6 years
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Secondary outcome [8]
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Cohorts 1 and 2: PFS per RECIST v1.1 assessed by Investigator
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Assessment method [8]
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The time from randomization to date of first documentation of disease progression or death.
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Timepoint [8]
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Up to approximately 6 years
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Secondary outcome [9]
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Cohort 2: PFS per RECIST v1.1 assessed by BICR
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Assessment method [9]
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The time from randomization to date of first documentation of disease progression or death.
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Timepoint [9]
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Up to approximately 6 years
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Secondary outcome [10]
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Cohorts 1 and 2: Number of participants reporting adverse events (AEs) and Serious adverse events (SAEs)
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Assessment method [10]
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Timepoint [10]
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Until 30 days post last dose, up to approximately 6 years
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Secondary outcome [11]
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Cohorts 1 and 2: Number of Participants with Clinically Significant Changes in Laboratory Results
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Assessment method [11]
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Timepoint [11]
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Until the end of treatment, up to approximately 6 years
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Secondary outcome [12]
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Cohorts 1 and 2: Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG)
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Assessment method [12]
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Timepoint [12]
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Until the end of treatment, up to approximately 6 years
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Secondary outcome [13]
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Cohorts 1 and 2: Number of Participants with Clinically Significant Changes in vital signs
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Assessment method [13]
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Timepoint [13]
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Until the end of treatment, up to approximately 6 years
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Secondary outcome [14]
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Cohorts 1 and 2: Change from Baseline in Euroqol-5 Dimensions (EQ-5D) Questionnaire
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Assessment method [14]
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Timepoint [14]
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Until the end of treatment, up to approximately 6 years
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Secondary outcome [15]
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Cohorts 1 and 2: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
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Assessment method [15]
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Timepoint [15]
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Until the end of treatment, up to approximately 6 years
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Eligibility
Key inclusion criteria
Key
* 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/01/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2030
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Actual
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Sample size
Target
956
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Cancer Research SA - Adelaide
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Recruitment hospital [2]
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Calvary Mater Newcastle - Hunter
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Recruitment hospital [3]
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Icon Cancer Centre - South Brisbane
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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2310 - Hunter
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Recruitment postcode(s) [3]
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4066 - South Brisbane
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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Country [2]
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United States of America
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State/province [2]
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Nebraska
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Country [3]
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United States of America
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State/province [3]
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New Jersey
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Country [4]
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United States of America
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State/province [4]
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South Carolina
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Country [5]
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Georgia
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State/province [5]
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Tbilisi
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
BicycleTx Limited
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT06225596
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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BicycleTx Limited
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Address
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Country
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Phone
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617-945-8155
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT06225596
Download to PDF