The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease; and disease-free survival (DFS) in participants treated with TAR-200 alone with papillary disease only (Cohort 4).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
TAR-200 will be administered transuretherally.
Cetrelimab will be administered.
Del Sol Research Management, LLC
Tucson, Arizona, United States
University of Southern California
Los Angeles, California, United States
Genesis Healthcare Partners - Genesis Research Greater Los Angeles
Sherman Oaks, California, United States
The Urology Center of Colorado
Denver, Colorado, United States
Foothills Urology - Golden Off
Golden, Colorado, United States
Cohort 1, 2, and 3: Overall Complete Response (CR) Rate
Overall CR rate is defined as the percentage of participants achieving a CR at any time post-treatment. It will be measured by determining the percentage of participants without presence of high-grade disease using results from cystoscopy and centrally read urine cytology at any time point.
Time frame: Up to 5 years
Cohort 4: Disease-free Survival (DFS)
DFS will be measured as the time from the date of first dose of study treatment to either the time of the first recurrence of high-risk disease, progression, or death due to any cause, whichever occurs first.
Time frame: Up to 5 years
Cohort 1, 2, and 3: Duration of Response (DOR)
DOR is defined from the date of first CR achieved to the date of first evidence of recurrence or progression or death (whichever is earlier) for participants who achieve a CR.
Time frame: Up to 5 years
Overall Survival (OS)
OS, defined as the time from the date of first dose of study treatment to death; if a participant has not died at the time of analysis, the participant will be censored at the date last known alive.
Time frame: Up to 5 years
Cohort 1, 2, and 4: Concentrations of Gemcitabine and 2',2' difluorodeoxyuridine (dFdU) in Urine and Plasma
Concentrations of gemcitabine and its metabolite dFdU in urine and plasma will be assessed.
Time frame: Up to Week 21
Cohort 1 and 3: Serum Concentration of Anti-cetrelimab Antibodies
Serum concentration of anti-cetrelimab antibodies will be assessed using a validated immunoassay for anti-drug antibody (ADA) analysis.
Time frame: Predose, up to 3 years
Number of Participants with Anti-cetrelimab Antibodies
Number of participants with anti-cetrelimab antibodies will be reported.
Time frame: Predose, up to 3 years
Change from Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ) -C30 Scores
EORTC QLQ-C30 is a core 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. It incorporates 5 functional scales (physical, role, cognitive, emotional, and social functioning), 3 symptom scales (fatigue, pain, and nausea or vomiting), and a global health status or HRQoL scale. Ratings for each item range from 1 (not at all) to 4 (very much).
Time frame: Baseline, up to 3 years and 4 months
Change from Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores
EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with superficial (non-muscle-invasive) bladder cancer. The questionnaire is designed to supplement the QLQ-C30 and incorporates 6 multi-item scales and 5 single items. Ratings for each item range from 1 (not at all) to 4 (very much).
Time frame: Baseline, up to 3 years and 4 months
Number of Participants with Adverse Events (AEs) by Severity Grades
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity grades 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 5 years
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DuPage Medical Group
Lisle, Illinois, United States
Urology of Indiana
Greenwood, Indiana, United States
Wichita Urology Group
Wichita, Kansas, United States
Michigan Institute of Urology
Troy, Michigan, United States
NYU Langone Health
New York, New York, United States
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