This study will test a drug called enfortumab vedotin in participants with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC). This study will also evaluate what the side effects are and if the drug works to treat NMIBC. A side effect is anything a drug does to your body besides treating your disease. In this study enfortumab vedotin will be put into the bladder using a catheter. A catheter is a thin tube that can be put into your bladder.
The study will be comprised of 2 parts. The first part (dose escalation) will find the highest dose of enfortumab vedotin that does not cause unacceptable side effects in participants. The second part (dose expansion) will use the dose found in the first part to test how well the drug works. All participants will receive enfortumab vedotin. Treatment on the study will occur during the induction and maintenance phases, and participants will enter a follow-up period after completion of the maintenance phase.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Given into the bladder (intravesically)
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Mayo Clinic
Scottsdale, Arizona, United States
UCLA Department of Medicine - Hematology & Oncology
Los Angeles, California, United States
University of California, Irvine
Orange, California, United States
University of California at San Francisco
San Francisco, California, United States
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.
Time frame: Approximately 1 year
Incidence of laboratory abnormalities
To be summarized using descriptive statistics.
Time frame: Approximately 1 year
Incidence of dose limiting toxicities (DLTs)
To be summarized using descriptive statistics.
Time frame: 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.
Time frame: Approximately 1 year
PK of enfortumab vedotin: Maximum concentration (Cmax)
Cmax will be recorded from the PK blood samples collected.
Time frame: Approximately 1 year
PK of enfortumab vedotin: Time to maximum concentration concentration (tmax)
Tmax will be recorded from the PK blood samples collected.
Time frame: Approximately 1 year
PK of enfortumab vedotin: Apparent terminal half-life (t1/2)
T1/2 will be recorded from the PK blood samples collected.
Time frame: Approximately 1 year
PK of enfortumab vedotin: Trough concentration (Ctrough)
Ctrough will be recorded from the PK blood samples collected.
Time frame: Approximately 1 year
Incidence of antitherapeutic antibodies (ATAs) to enfortumab vedotin
Blood samples for ATA analysis will be collected.
Time frame: Approximately 1 year
Complete response (CR) rate
CR rate is defined as the proportion of subjects achieving CR.
Time frame: 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.
Time frame: Up to 5 years
Rate of cystectomy
The proportion of subjects who subsequently undergo cystectomy.
Time frame: 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.
Time frame: Up to 5 years
Cystectomy-free survival
The time from start of study treatment to cystectomy or death due to any cause.
Time frame: Up to 5 years
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Stanford Health Care
Stanford, California, United States
Northwestern University-Feinberg School of Medicine
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Markey Cancer Center / University of Kentucky
Lexington, Kentucky, United States
Johns Hopkins Medical Center
Baltimore, Maryland, United States
...and 22 more locations