A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer

Phase 3

Not yet recruiting

• Conditions: Non-Muscle Invasive Bladder Neoplasms
• Interventions: Drug: TAR-210; Drug: Mitomycin C; Drug: Gemcitabine

• Registration Number: NCT06919965
• Lead Sponsor: Janssen Research & Development, LLC

Brief Summary

The main purpose of this study is to compare the disease-free survival (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of high-risk non-muscle-invasive bladder cancer (HR-NMIBC).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-02
• Study First Submitted QC: 2025-04-02
• Study First Posted: 2025-04-09
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-23
• Study Start: 2025-10-03
• Primary Completion: 2027-08-13
• Study Completion: 2032-03-16

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: TAR-210	TAR-210	Participants in Group A will have TAR-210 inserted in the bladder on Day 1. TAR-210 will be inserted over a treatment duration of approximately 2 years.
Group B: Mitomycin C (MMC) or Gemcitabine	Mitomycin C	Participants in Group B will receive intravesical mitomycin C (MMC) or gemcitabine (investigator's choice) once weekly for 4 to 6 induction doses followed by maintenance dosing once monthly for up to 1 year. An optional second year of additional maintenance can be added at the investigator's discretion.
Group B: Mitomycin C (MMC) or Gemcitabine	Gemcitabine	Participants in Group B will receive intravesical mitomycin C (MMC) or gemcitabine (investigator's choice) once weekly for 4 to 6 induction doses followed by maintenance dosing once monthly for up to 1 year. An optional second year of additional maintenance can be added at the investigator's discretion.

Primary Outcome Measures

Name	Time	Method
Disease-free Survival (DFS)	Up to 5 years	DFS is measured as the time from randomization to the date of the first recurrence of HR-NMIBC (high-grade Ta, any T1 or carcinoma in situ \[CIS\]), progression, or death due to any cause, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
Time to Disease Worsening (TTDW)	Up to 5 years	TTDW is measured as the time from randomization to the date of cystectomy, systemic therapy, or radiation therapy, whichever occurs first.
Change from Baseline in European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-C30 Scores	Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and 96	EORTC QLQ-C30 is a 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. It includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea or vomiting), a global health status or HRQoL scale and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicate greater functioning, better global health status, or more severe symptoms.
Percentage of Participants With Meaningful Change From Baseline in EORTC-QLQ-NMIBC24 Scores	Weeks 12, 24, 36, 48, 60, 72, 84 and 96	EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with NMIBC. The questionnaire is designed to supplement the QLQ-C30 and incorporates 6 multi-item scales (urinary symptoms, malaise, future worries, bloating and flatulence, sexual function and male sexual problems) and 5 single items (intravesical treatment issues, sexual intimacy, worries about risk of contaminating partner, sexual enjoyment, and female sexual problems). Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores represent a high level of symptoms or problems, except for sexual function and sexual enjoyment, where a higher score represents a higher level of functioning.
Number of Participants with Overall Side Effects Measured by EORTC Question 168 (Q168)	Up to Week 96	EORTC Q168 is a single item from the EORTC item library used to measure the overall impact of treatment side effects. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Higher score indicates greater impact.
Recurrence-Free Survival (RFS)	Up to 5 years	RFS is measured as the time from randomization to the date of the first recurrence of HR-NMIBC (high-grade Ta, any T1, or CIS), or death due to any cause, whichever occurs first.
Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0	Up to 5 years	Number of participants with AEs by severity grade as assessed by CTCAE version 5.0 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.
Time to Next Intervention (TTNI)	Up to 5 years	TTNI (i.e., transurethral resection of bladder tumor \[TURBT\], radical cystectomy \[RC\], radiation therapy \[RT\], or chemotherapy) is measured as the time from randomization to the date of next intervention (localized or systemic) for the treatment of urothelial carcinoma (UC).
Time to Progression (TTP)	Up to 5 years	TTP is measured as the time from randomization to the date of first documented evidence of disease progression (i.e., progression to muscle-invasive bladder cancer \[MIBC\] \[T greater than or equal to {\>=} 2\], lymph node \[N+\], or distant disease \[M+\]), or death due to disease progression, whichever occurs first.
Overall Survival (OS)	Up to 5 years	OS is defined as the time from randomization to death due to any cause.
Number of Participants With Change from Baseline in Laboratory Abnormalities	Up to 5 years	Number of participants with change from baseline in laboratory abnormalities (hematology, serum chemistry and urine analysis) will be reported.
Change from Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores	Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and 96	EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with NMIBC. The questionnaire is designed to supplement the QLQ-C30 and incorporates 6 multi-item scales (urinary symptoms, malaise, future worries, bloating and flatulence, sexual function and male sexual problems) and 5 single items (intravesical treatment issues, sexual intimacy, worries about risk of contaminating partner, sexual enjoyment, and female sexual problems). Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores represent a high level of symptoms or problems, except for sexual function and sexual enjoyment, where a higher score represents a higher level of functioning.
Percentage of Participants With Meaningful Change From Baseline in EORTC-QLQ-C30 Scores	Weeks 12, 24, 36, 48, 60, 72, 84 and 96	EORTC QLQ-C30 is a 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. It includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea or vomiting), a global health status or HRQoL scale and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicate greater functioning, better global health status, or more severe symptoms.
Number of Participants With Change from Baseline in Vital Signs Abnormalities	Up to 5 years	Number of participants with change from baseline in vital signs (temperature, pulse/heart rate, respiratory rate and blood pressure) will be reported.