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

Purpose

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).

Condition

  • Non-Muscle Invasive Bladder Neoplasms

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Histologically confirmed diagnosis by local pathology of papillary-only HR-NMIBC (defined as high-grade Ta or any T1, no CIS). Mixed histology tumors are allowed if urothelial differentiation is predominant. However, neuroendocrine, and small cell variants will be excluded - Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue) as determined by central or local testing - All visible tumor completely resected prior to randomization. Urine cytology must not be positive or suspicious for high grade UC before randomization. For participants with lamina propria invasion (T1) on the screening biopsy/TURBT, muscularis propria must be present to rule out MIBC - Participants must have had either: a. Adequate Induction (5 of 6 doses) and either 2 of 3 doses of Maintenance or 2 of 6 doses of second Induction of BCG with high-grade T1 disease at first disease assessment after induction or high-grade Ta/any T1 disease within 6 months after last BCG (BCG-unresponsive population); b. had adequate induction (5 or 6 doses) with or without maintenance BCG with high-grade Ta/any T1 disease within 12 months after last BCG excluding BCG-unresponsive (BCG-experienced population); or c. been unable to complete an induction course of BCG with at least 5 doses due to grade >= 2 toxicity requiring BCG discontinuation (BCG intolerant population) - Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2 - Must be ineligible for or refusing radical cystectomy (RC)

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 [i.e.], T2, T3, T4, N+, and/or M+) - Active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. Allowed recent second or prior malignancies: a. Any malignancy that was not progressing nor requiring treatment change in the last 12 months; b. Malignancies treated within the last 12 months and considered at very low risk for recurrence for example (e.g.): non-melanoma skin cancers (treated with curative therapy or localized melanoma treated with curative surgical resection alone), non-invasive cervical cancer, breast cancer (adequately treated lobular CIS or ductal CIS, localized breast cancer and receiving antihormonal agents), localized prostate cancer ([N0, M0] with a Gleason score less than or equal to [<=] 7a, treated locally only [radical prostatectomy/radiation therapy/focal treatment]) and other malignancy that is considered at minimal risk of recurrence - 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 210 - A history of clinically significant polyuria with recorded 24 hour urine volumes greater than (>) 4,000 milliliters (mL) - Indwelling catheters are not permitted; however, intermittent catheterization is acceptable

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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
    TAR-210 will be administered intravesically.
    Other names:
    • JNJ-42756493
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
    MMC will be administered intravesically.
  • Drug: Gemcitabine
    Gemcitabine will be administered intravesically.

Recruiting Locations

Colorado Clinical Research
Lakewood 5427946, Colorado 5417618 80228

Georgia Urology
Atlanta 4180439, Georgia 4197000 30328

Comprehensive Urology
Royal Oak 5007804, Michigan 5001836 48073

UroHealth Partners
Omaha 5074472, Nebraska 5073708 68114

Dayton Physicians Network Urology
Centerville 4508204, Ohio 5165418 45459

Helios Clinical Research, LLC
Middleburg Heights 5162851, Ohio 5165418 44130

Oregon Urology Institute
Springfield 5754005, Oregon 5744337 97477

MidLantic Urology
Bala-Cynwyd 5178892, Pennsylvania 6254927 19004

MidLantic Urology
Lancaster 5197079, Pennsylvania 6254927 17604

University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
Pittsburgh 5206379, Pennsylvania 6254927 15232

Carolina Urologic Research Center
Myrtle Beach 4588718, South Carolina 4597040 29572

The Conrad Pearson Clinic
Germantown 4624601, Tennessee 4662168 38138

Urology Austin
Austin 4671654, Texas 4736286 78745

Urology San Antonio PA dba USA Clinical Trials
San Antonio 4726206, Texas 4736286 78229

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com