The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
Important Notice Regarding the Scientific Information You Have Requested
You are being redirected to the scientific presentations section. The information provided here relate to investigational assets. The safety and efficacy of the unapproved assets has not been proven.
Please acknowledge that you understand this before proceeding.
Active enrolling
United States
for more information at clinicaltrials.gov
EXPERIMENTAL: Arm A
Enfortumab vedotin + pembrolizumab (EV + P)
DRUG: Enfortumab vedotin
Enfortumab vedotin administered as an IV infusion on Days 1 and 8 of every 3-week cycle up to cycle 9.DRUG: Pembrolizumab
IV infusion on Day 1 of every 3-week cycle up to cycle 17.ACTIVE_COMPARATOR: Arm B
Concurrent Chemoradiotherapy (cCRT)
RADIATION: Conventional Radiotherapy
64 Gy in 32 fractions over 6.5 weeks administered to the participant's bladder only or the bladder and prophylactically to pelvic nodes.RADIATION: Hypofractionated Radiotherapy
55 Gy in 20 fractions over 4 weeks administered to the participant's bladder only.DRUG: Cisplatin
40 mg of cisplatin per meter squared of body surface area, administered once weekly via IV infusion during radiation OR 20 mg of cisplatin per meter squared of body surface area per day on Days 1 and 2 weekly via IV infusion during radiation.DRUG: Fluorouracil
500 mg per meter squared of body surface area per day on Days 1-5 (week 1) and Days 22 26 (week 3) administered as continuous IV infusion during radiation in combination with mitomycin C.DRUG: Mitomycin C
12 mg per meter squared of body surface area administered as an IV bolus on Day 1 during radiation in combination with fluorouracil.DRUG: Gemcitabine
100 mg per meter squared of body surface area administered once weekly via IV infusion during radiation OR 27 mg per meter squared of body surface area administered twice weekly via IV infusion during radiationBladder-intact Event Free Survival (BI-EFS) by Blinded Independent Central Review (BICR)
BI-EFS is defined as the time from randomization to any of the following events: histologically confirmed persistent or residual MIBC post-treatment confirmed by BICR, histologically confirmed recurrent MIBC by BICR, disease progression by BICR, cystectomy, or death from any cause.
Up to approximately 45.5 months
Overall Survival (OS)
Time from randomization to death due to any cause.
Up to approximately 60 months
Bladder-intact Event Free Survival (BI-EFS) by Investigator
BI-EFS is defined as the time from randomization to any of the following events: histologically confirmed persistent or residual MIBC post-treatment, histologically confirmed recurrent MIBC, disease progression, cystectomy, or death from any cause.
Up to approximately 45.5 months
Complete clinical response (cCR) rate by Blinded Independent Central Review (BICR) and Investigator
cCR is defined as no radiographic evidence of residual or metastatic disease on imaging, negative cystoscopy, negative pathology except for low-grade Ta, and negative urine cytology.
Up to approximately 60 months
Metastasis-Free Survival (MFS) by Blinded Independent Central Review (BICR) and Investigator
Time from randomization to radiologically or pathologically confirmed distant metastasis, or death due to any cause, whichever occurs first.
Up to approximately 60 months]
Time to Cystectomy
The time from randomization to cystectomy.
Up to approximately 60 months
Disease Free Survival (DFS) by Blinded Independent Central Review (BICR) and Investigator
The time from cCR to local recurrence or distant metastases, a second primary bladder cancer, or death due to any cause, whichever occurs first.
Up to approximately 60 months
Cystectomy Free Survival (CFS)
The time from randomization to cystectomy or death due to any cause, whichever occurs first.
Up to approximately 60 months
Number of Participants with Treatment Emergent Adverse Event (TEAE)
An AE is any untoward medical occurrence in a participant who receives a study treatment without regard to possibility of causal relationship. Treatment-emergent are events between the first dose of study treatment and up to 30 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.
From start of study treatment up to 30 days after last dose of study drug (approximately up to 1.1 years)
Number of Participants with Serious TEAEs
An SAE is any AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 90 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
From start of treatment up to 90 days after the last dose of study treatment (approximately up to 1.3 years)
390
Sponsor: Astellas Pharma Global Development, Inc.
Collaborator: Pfizer
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number:
NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
NCT07566156
Back
