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
Cohorts 1, 2, and 3: Overall Complete Response (CR) Rate
Overall CR rate was defined as the percentage of participants who met at least one of the following: negative cystoscopy and negative (including atypical) centrally read urine cytology, or positive cystoscopy with biopsy-proven benign or low-grade non-muscle invasive bladder cancer (NMIBC) and negative (including atypical) centrally read cytology at any time point.
Time frame: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Cohort 4: Disease-free Survival (DFS)
DFS was defined as the time from the date of first dose of study treatment to the time of one of the following events, whichever occurred first: (1) The first recurrence of high-risk disease (high-grade Ta, any T1 or CIS), (2) progression to muscle invasive bladder cancer (MIBC) (T greater than or equal to \[\>=\] 2) or to lymph node (N+) or to distant disease (M+), whichever occurred first, (3) Death due to any cause.
Time frame: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Cohorts 1, 2, and 3: Number of Participants With at Least 12 Months Duration of Response
DOR was defined as the date of first complete response (CR) achieved to the date of first evidence of recurrence or progression or death, using cystoscopy, centrally read bladder biopsy and urine cytology, and imaging, if available. Complete response was defined as having a negative cystoscopy and negative (including atypical) centrally assessed urine cytology, or positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative (including atypical) centrally assessed cytology at any time point. Number of participants with at least 12 months duration of response were reported.
Time frame: From onset of first CR up to clinical cut-off date 3rd July 2025 (up to 47.3 months)
Overall Survival (OS)
Time frame: From Week 0 up to 6 years 7 months
Cohorts 1, 2, and 4: Plasma Concentrations of Gemcitabine and 2',2' Difluorodeoxyuridine (dFdU) (Metabolite)
Plasma concentrations of gemcitabine and dFdU were reported.
Time frame: Predose at Week 0 and at any time between Days 2-7 during Weeks 3, 6, 9, 15, 18, and 21 postdose
Cohorts 1 and 2: Maximum Observed Urine Concentration (Cmax) of Gemcitabine and dFdU (Metabolite)
Cmax was defined as maximum observed urine concentration.
Time frame: At Week 0
Cohort 4: Urine Concentration of Gemcitabine and dFdU (Metabolite)
Urine concentrations of gemcitabine and dFdU were reported.
Time frame: At Weeks 3, 6, 9, 15, 18, and 21
Cohort 1and 3: Serum Concentration of Cetrelimab
Serum concentration of cetrelimab were reported.
Time frame: At Weeks 0, 3, 12, 24, 48, 60, 84 (end of infusion) [EOI]
Cohort 3: Serum Concentration of Cetrelimab
Serum concentration of cetrelimab were reported.
Time frame: At Weeks 60 (EOI)
Cohorts 1 and 3: Number of Participants With Anti-cetrelimab Antibodies
Number of participants positive to anti-cetrelimab antibodies was reported using validated immunoassay for anti-drug antibody (ADA) analysis.
Time frame: From date of first dose up to clinical cut-off date 3rd July 2025 (54 months)
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ) -C30 Scores
Time frame: From Week 0 up to 6 years 7 months
Change From Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores
Time frame: From Week 0 up to 6 years 7 months
Time to Symptom Deterioration as Assessed by European Organisation for Research and Treatment of Cancer Qualityof-life Questionnaire (EORTC QLQ) -C30 Scores
Time frame: From Week 0 up to 6 years 7 months
Time to Symptom Deterioration as Assessed by EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores
Time frame: From Week 0 up to 6 years 7 months
Number of Participants With Adverse Events (AEs) by Severity Grades
Time frame: From Week 0 up to 6 years 7 months
Number of Participants With Clinical Laboratory Abnormalities by Severity Grades
Time frame: From Week 0 up to 6 years 7 months
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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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