Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 2/Phase 3
BicycleTx Limited (Voir sur ClinicalTrials)
janvier 2024
décembre 2030
24 juin 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Europeen Georges Pompidou | Contact (sur clinicalTrials) | ||||
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine-Lacassagne - 06189 - Nice - France | Contact (sur clinicalTrials) | ||||
| Centre d'Oncologie de Gentilly - 54100 - Nancy - France | Contact (sur clinicalTrials) | ||||
| Centre Leon Berard - 69008 - Lyon - France | Contact (sur clinicalTrials) | ||||
| CHU Bordeaux - Hopital Saint-Andre - 33000 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| CHU de Limoges - Hopital Dupuytren 1 - 87042 - Limoges - France | Contact (sur clinicalTrials) | ||||
| CHU Poitiers - Pole Regional de Cancerologie de Poitiers (PRC) - 86000 - Poitiers - France | Contact (sur clinicalTrials) | ||||
| Groupement de Cooperation Sanitaire (GCS) ELSAN - Clinique Victor Hugo - 72000 - Le Mans - France | Contact (sur clinicalTrials) | ||||
| HCL Centre Hospitalier Lyon Sud - 69495 - Pierre-Benite Cedex - France | Contact (sur clinicalTrials) | ||||
| ICM - Institut Regional du Cancer de Montpellier - 34298 - Montpellier Cedex 5 - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonie - 33076 - Bordeaux Cedex - France | Contact (sur clinicalTrials) | ||||
| Institut Mutualiste Montsouris - 75014 - Paris - France | Contact (sur clinicalTrials) | ||||
| Institut Paoli-Calmettes - 13273 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Service d'Oncologie Medicale - CHRU Besancon - 25000 - Besançon - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
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.
Key
- 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