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NCT Number: NCT06211764

A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)

The purpose of this study is to compare disease free survival (DFS) in participants with recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) within 1 year of last dose of Bacillus Calmette-Guérin (BCG) therapy and who refused or are unfit for Radical Cystectomy (RC), receiving TAR-200 versus investigator's choice of single agent intravesical chemotherapy.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Non-Muscle Invasive Bladder Neoplasms Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinica Santa Isabel, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed diagnosis by local pathology (within 90 days of documented informed consent) of recurrent, papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) [defined as high-grade Ta or any T1, no carcinoma in situ (CIS)]
  • Participants with variant histologic subtypes are allowed if tumor(s) demonstrate urothelial (transitional cell histology) predominance. However, neuroendocrine, and small cell variants will be excluded
  • Participants must be ineligible for or have elected not to undergo Radical Cystectomy (RC)
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2

Exclusion criteria

  • Presence of CIS at any point from time of diagnosis of papillary-only HR-NMIBC recurrence to randomization. Additionally, presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, N+, and/or M+)
  • Presence of any bladder or urethral anatomic feature that, in the opinion of the Investigator, may prevent the safe placement, indwelling use, or removal of TAR-200. Participants with tumors involving the prostatic urethra in men will be excluded
  • A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (>4000 mL)
  • Indwelling catheters are not permitted; however, intermittent catheterization is acceptable
  • Previous treatment with TAR-200

Treatment and study plan

TAR-200

Drug

Participants will receive TAR-200 intravesically.

Other names: JNJ-17000139

mitomycin C

Drug

Participants will receive MMC intravesically.

Gemcitabine

Drug

Participants will receive gemcitabine intravesically.

Primary outcomes

  1. Disease-free Survival (DFS)

    Time frame: Up to 6 years 7 months

    DFS will be measured as the time from randomization to the time of the first recurrence of high-risk non-muscle-invasive bladder cancer (HR-NMIBC) [high grade (HG) Ta, any T1 or carcinoma in situ (CIS)], progression, or death due to any cause, whichever occurs first.

Secondary outcomes

  1. Recurrence-Free Survival (RFS)

    Time frame: Up to 6 years 7 months

    RFS will be measured as the time from randomization to the time of the first recurrence of HR-NMIBC (HG Ta, any T1 or CIS), or death due to any cause, whichever occurs first.

  2. Time to Next Intervention (TTNI)

    Time frame: Up to 6 years 7 months

    TTNI will be measured as the time from randomization to the time of next intervention (localized or systemic) for the treatment of bladder cancer.

  3. Time to Disease Worsening (TTDW)

    Time frame: Up to 6 years 7 months

    TTDW is measured as the time from randomization to cystectomy, systemic therapy, or radiation therapy (treatments of disease worsening).

  4. Time to Progression (TTP)

    Time frame: Up to 6 years 7 months

    TTP will be measured as the time from randomization to the time of first documented evidence of disease progression (that is, progression to muscle-invasive bladder cancer [MIBC] [T greater than or equal to {>=} 2], lymph node disease [N+], or distant disease [M+]), or death due to disease progression, whichever occurs first.

  5. Overall Survival (OS)

    Time frame: Up to 6 years 7 months

    OS is defined as the time from randomization to death, due to any cause.

  6. DFS Rate at 12 and 24 Months

    Time frame: At 12 and 24 months

    DFS rate that is percentage of participants with DFS at 12 and 24 months will be reported.

  7. Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE)

    Time frame: Up to 6 years 7 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 Change from Baseline in Laboratory Abnormalities

    Time frame: Up to 6 years 7 months

    Number of participants with change from baseline in laboratory abnormalities (including hematology, clinical chemistry and routine urinalysis) will be reported.

  9. Number of Participants With Change from Baseline in Vital Signs Abnormalities

    Time frame: Up to 6 years 7 months

    Number of participants with change from baseline in vital signs including temperature, pulse/heart rate, respiratory rate, and blood pressure (systolic and diastolic) (supine) will be reported.

  10. Change from Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ) - C30 Scores

    Time frame: Up to 5 years

    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), and a global health status or HRQoL scale. Ratings for each item range from 1 (not at all) to 4 (very much).

  11. Change from Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores

    Time frame: Up to 5 years

    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).

  12. Proportion of Participants With Meaningful Change in EORTC QLQ-C30 and EORTC QLQ-NMIBC24 Scores

    Time frame: Up to 5 years

    Proportion of participants with meaningful change in EORTC QLQ-C30 and EORTC QLQ-NMIBC24 scores will be reported.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

17000139BLC3004: 17000139BLC3004 [SunRISe-5] Ph III HR NMIBC BCG Exp/UR Pap (N=250)

Acronym: SunRISe-5

Important dates

Study start
2024
Primary completion
2030
Study completion
2031
First posted
Jan 18, 2024
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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