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.
Active enrolling
United States, Canada, France, Germany, Spain, United Kingdom
for more information at clinicaltrials.gov
EXPERIMENTAL: Enfortumab vedotin: Dose escalation cohort
During the induction phase, participants will receive enfortumab vedotin once a week for 6 weeks. During the maintenance phase, participants will receive enfortumab vedotin once a month for 9 doses.
DRUG: Enfortumab vedotin
Given into the bladder (intravesically)
EXPERIMENTAL: Enfortumab vedotin: Dose expansion cohort
During the induction phase, participants will receive enfortumab vedotin once a week for 6 weeks. During the maintenance phase, participants will receive enfortumab vedotin once a month for 9 doses.
DRUG: Enfortumab vedotin
Given into the bladder (intravesically)
Incidence of adverse events (AEs)
An AE is any untoward medical occurrence in a subject or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Approximately 1 year
Incidence of laboratory abnormalities
To be summarized using descriptive statistics.
Approximately 1 year
Incidence of dose limiting toxicities (DLTs)
To be summarized using descriptive statistics.
Approximately 7 weeks
Pharmacokinetics (PK) of enfortumab vedotin: Area under the concentration-time curve (AUC)
AUC will be recorded from the PK blood samples collected.
Approximately 1 year
PK of enfortumab vedotin: Maximum concentration (Cmax)
Cmax will be recorded from the PK blood samples collected.
Approximately 1 year
PK of enfortumab vedotin: Time to maximum concentration concentration (tmax)
Tmax will be recorded from the PK blood samples collected.
Approximately 1 year
PK of enfortumab vedotin: Apparent terminal half-life (t1/2)
T1/2 will be recorded from the PK blood samples collected.
Approximately 1 year
PK of enfortumab vedotin: Trough concentration (Ctrough)
Ctrough will be recorded from the PK blood samples collected.
Approximately 1 year
Incidence of antitherapeutic antibodies (ATAs) to enfortumab vedotin
Blood samples for ATA analysis will be collected.
Approximately 1 year
Complete response (CR) rate
CR rate is defined as the proportion of subjects achieving CR.
Up to 24 months
Duration of CR
The time from first documented CR to the first evidence of recurrence, progression, or death due to any cause.
Up to 5 years
Rate of cystectomy
The proportion of subjects who subsequently undergo cystectomy.
Up to 5 years
Progression-free survival
The time from start of study treatment to the first evidence of progression or death due to any cause.
Up to 5 years
Cystectomy-free survival
The time from start of study treatment to cystectomy or death due to any cause.
Up to 5 years
58
Sponsor: Astellas Pharma Global Development, Inc.
Collaborator: Seagen Inc.
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.
NCT05014139
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