The purpose of study is to compare bladder intact-event free survival (BI-EFS) in participants receiving TAR-200 in combination with intravenous (IV) cetrelimab versus concurrent chemoradiotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
518
Participants will receive intravenous Cetrelimab.
Participants will receive intravesical TAR-200.
Participants will receive cisplatin intravenously.
Time from Randomization to the First Bladder Intact Event-free Survival (BI-EFS) event
Time from randomization to the first BI-EFS event includes histologically proven presence of muscle-invasive bladder cancer (MIBC), clinical evidence of nodal or metastatic disease (as assessed by RECIST 1.1 criteria), radical cystectomy (RC), or death due to any cause.
Time frame: Up to 8 years
Metastasis-free survival (MFS)
MFS is measured from time from randomization to first radiologic (as assessed by RECIST 1.1 criteria) evidence of metastatic disease or death due to any cause.
Time frame: Up to 8 years
Overall Survival (OS)
OS is defined as time from randomization to death.
Time frame: Up to 8 years
Overall Response Rate (ORR)
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR). CR is defined as Negative biopsy, and Computed tomography/Magnetic resonance imaging (CT/MRI) showing no evidence of locally advanced or metastatic disease. PR (down-staging) is defined as biopsy proven non-muscle invasive disease (Ta, T1, Tis) and CT/MRI showing no evidence of locally advanced or metastatic disease. Non-Response (NR) includes those not achieving a CR or PR. Those who do not undergo a biopsy will be considered Non-Evaluable (NE).
Time frame: Up to 8 years
Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE)
Number of Participants with AEs by Severity as assessed by CTCAE version 5 will be reported. Grade refers to the severity of the AE as follows: Grade 1- Mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2- Moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental Activities of Daily Living (ADL); Grade 3- Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care ADL; Grade 4- Life-threatening consequences, urgent intervention indicated; Grade 5- Death related to AE.
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Participants will receive gemcitabine intravenously.
Participants will receive conventional radiation therapy for bladder (64 gy).
Participants will receive hypo-fractioned radiation therapy for bladder (55 gy).
Loma Linda Univ Faculty Medic
Loma Linda, California, United States
University of Southern California
Los Angeles, California, United States
Providence Saint John s Health Center
Santa Monica, California, United States
Stanford University Medical Center
Stanford, California, United States
The Urology Center of Colorado
Denver, Colorado, United States
Foothills Urology - Golden Off
Golden, Colorado, United States
Boca Raton Regional Hospital
Boca Raton, Florida, United States
Urological Research Network
Hialeah, Florida, United States
Memorial Healthcare System
Pembroke Pines, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
...and 280 more locations
Time frame: Up to 8 years
Number of Participants with AEs by Severity according to Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE)
NCI PRO-CTCAE is a patient-reported item library used to evaluate symptomatic treatment-emergent adverse events in participants on cancer clinical trials. The items selected for this study include all NCI PRO-CTCAE gastrointestinal items and urinary items. These items include taste changes, decreased appetite, nausea, vomiting, heartburn, gas, bloating, hiccups, constipation, diarrhea, abdominal pain, fecal incontinence, painful, urination, urinary urgency, urinary frequency, change in usual urine color, and urinary incontinence.
Time frame: Up to 8 years
Number of Participants with Clinical Laboratory Abnormalities
Number of participants with clinical laboratory abnormalities will be reported. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.
Time frame: Up to 8 years