A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)
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1. Event-free Survival (EFS) (Time Frame - Up to 5 years 2 months): EFS is defined as the time from randomization to either the time of the first recurrence of high-risk disease, progression, or death due to any cause, whichever occurs first. For participants with carcinoma In-situ (CIS), persistent disease at 6 months (Week 24) is also considered an EFS event. Progression is defined as: an increase of stage from Ta to T1 or from CIS to T1 or 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 occurs first.
Secondary outcome:
1. Overall Complete Response (CR) Rate (Time Frame - Up to 5 years 2 months): Overall CR will be measured by determining the percentage of participants with CIS who have no presence of high-risk disease at 6 months.
2. Duration of CR (Time Frame - Up to 5 years 2 months): Duration of CR is defined from the time of first CR achieved to first evidence of recurrence, progression or death due to any cause (whichever occurs first) for participants who achieve a CR.
3. Recurrence-Free Survival (RFS) (Time Frame - Up to 5 years 2 months): RFS is defined as the time from randomization to the time of the first recurrence of high-risk disease, or death due to any cause, whichever occurs first.
4. Time to Progression (TTP) (Time Frame - Up to 5 years 2 months): TTP is defined as the time from randomization to the date of first documented evidence of disease progression or death due to disease progression, whichever occurs first.
5. Overall Survival (OS) (Time Frame - Up to 5 years 2 months): OS is defined as the time from randomization to death, due to any cause.
6. Cancer Specific Survival (CSS) (Time Frame - Up to 5 years 2 months): CSS is defined as the time from randomization to the date of death due to bladder cancer.
7. Number of Participants with Adverse Events (AEs) by Grades According to Common Terminology Criteria for Adverse Events (CTCAE) (Time Frame - Up to 5 years 2 months): Number of participants with AEs by severity grade as assessed by CTCAE version 5 will be reported. Grade refers to the severity of AE as follows: Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5- Death related to adverse event.
8. Number of Participants with Adverse Events (AEs) (Time Frame - Up to 5 years 2 months): Number of participants with AEs will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
9. Number of Participants with Change from Baseline in Laboratory Abnormalities (Time Frame - Up to 5 years 2 months): Number of participants with change from baseline in 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.
10. Number of Participants with Change from Baseline in Vital Signs Abnormalities (Time Frame - Up to 5 years 2 months): Number of participants with change from baseline in vital signs (blood pressure [systolic and diastolic], heart rate, temperature, and weight) abnormalities will be reported.
11. Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of life Questionnaire - Non-muscle Invasive Bladder Cancer EORTC QLQ- NMIBC 24 (Time Frame - Up to 5 years 2 months): EORTC QLQ-NMIBC 24 is a 24-item questionnaire for evaluating the Health-related quality of life (HRQoL) of participants with superficial (non-muscle-invasive) bladder cancer. The questionnaire is designed to supplement the quality of life questionnaire (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).
12. Time to Symptom Deterioration as Assessed by EORTC-QLQ-NMIBC 24 Scores (Time Frame - Up to 5 years 2 months): EORTC QLQ-NMIBC 24 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).
Experimental: Treatment Group A: TAR-200 + Cetrelimab Participants will receive intravesical TAR-200 once every 3 weeks (Q3W) and cetrelimab.
Active Comparator: Treatment Group B: Bacillus Calmette-Guerin (BCG) Vesiculture Participants will receive intravesical BCG once every week for 6 weeks (induction) and then followed by once every week for 3 weeks starting at Weeks 12, 24, 48, 72, and 96 (maintenance).
Experimental: Treatment Group C: TAR-200 Alone Participants will receive intravesical TAR-200 alone once Q3W.
TAR-200 (JNJ-17000139): TAR-200 will be administered intravesically.
Cetrelimab (JNJ-63723283): Cetrelimab will be administered.
BCG Vesiculture: BCG will be administered intravesically.
Quelle: ClinicalTrials.gov
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"A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)"
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