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

Browse trials for

• Non-Muscle Invasive Bladder Neoplasms 264

Study arms

• Experimental
  Group A: 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.

  Drug: TAR-210

• Active comparator
  Group B: Mitomycin C (MMC) or 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.

  Drug: Mitomycin C · Drug: Gemcitabine

Interventions

• DrugTAR-210

  TAR-210 will be administered intravesically.

  Also known as: JNJ-42756493

• DrugMitomycin C

  MMC will be administered intravesically.

• DrugGemcitabine

  Gemcitabine will be administered intravesically.

Primary outcomes

1. Disease-free Survival (DFS)

   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.

   Time frame: Up to 5 years

Secondary outcomes

1. Recurrence-Free Survival (RFS)

   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.

   Time frame: Up to 5 years

2. Time to Next Intervention (TTNI)

   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 frame: Up to 5 years

3. Time to Disease Worsening (TTDW)

   TTDW is measured as the time from randomization to the date of cystectomy, systemic therapy, or radiation therapy, whichever occurs first.

   Time frame: Up to 5 years

4. Time to Progression (TTP)

   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.

   Time frame: Up to 5 years

5. Overall Survival (OS)

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

   Time frame: Up to 5 years

6. Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

   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 frame: Up to 5 years

7. Number of Participants With Change from Baseline in Laboratory Abnormalities

   Number of participants with change from baseline in laboratory abnormalities (hematology, serum chemistry and urine analysis) will be reported.

   Time frame: Up to 5 years

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

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

   Time frame: Up to 5 years

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

   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.

   Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and 96

10. 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 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.

    Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and 96

11. Percentage of Participants With Meaningful Change From Baseline in EORTC-QLQ-C30 Scores

    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.

    Time frame: Weeks 12, 24, 36, 48, 60, 72, 84 and 96

12. Percentage of Participants With Meaningful Change From Baseline in EORTC-QLQ-NMIBC24 Scores

    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.

    Time frame: Weeks 12, 24, 36, 48, 60, 72, 84 and 96

13. Number of Participants with Overall Side Effects Measured by EORTC Question 168 (Q168)

    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.

    Time frame: Up to Week 96

Individual participant data

Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu