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Brief Title: 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

A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and Safety 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

INTRODUCTION

  • Org Study ID: CR109223
  • Secondary ID: 2020-004506-64, 17000139BLC3002
  • NTC ID: NCT05714202
  • Sponsor: Janssen Research & Development, LLC

BRIEF SUMMARY

The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B).

DETAILED DESCRIPTION

Bladder cancer is the tenth most common malignancy worldwide. About 75 percent (%) of bladder cancers are non-muscle invasive at diagnosis with approximately 25% of NMIBC patients have HR, NMIBC. The TAR-200/gemcitabine (JNJ-17000139) product is an intravesical drug delivery system regulated as an investigational drug. The drug constituent consists of gemcitabine and osmotic minitablets. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds programmed-cell death protein (PD)-1. The mainstay of treatment for HR-NMIBC is transurethral resection of bladder tumor, followed by intravesical treatment with BCG. In this study metronomic dosing of intravesical gemcitabine, delivered via TAR-200, alone or in combination with cetrelimab will be evaluated and compared against intravesical BCG. The study consists of a Screening phase, Treatment phase, and Follow-up phase. The total duration of the study will be up to 5 years and 2 months. Efficacy, Safety, pharmacokinetics (PK), and biomarkers will be assessed at specific time points during the study.

  • Overall Status
    Recruiting
  • Start Date
    March 23, 2023
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Event-free Survival (EFS)

Primary Outcome 1 - Timeframe: Up to 5 years 2 months

CONDITION

  • Bladder Cancer

ELIGIBILITY

Inclusion Criteria:
Histologically confirmed initial diagnosis by local pathology (within 90 days of the initial signed informed consent) of high grade non-muscle invasive bladder cancer (HR-NMIBC) (high-grade Ta, any T1 or carcinoma in-situ [CIS]), in participants who are Bacillus Calmette Guérin (BCG)-naïve. Mixed histology tumors are allowed if urothelial differentiation (transitional cell histology) is predominant. However, the presence of neuroendocrine, micropapillary, signet ring cell, plasmacytoid, or sarcomatoid features will make a participant ineligible

- BCG-naïve (participants who have not received prior intravesical BCG or who previously received but stopped BCG more than 3 years before date of randomization are eligible)

- All visible papillary disease must be fully resected (absent) prior to date of randomization and documented at baseline cystoscopy

- Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2

- All adverse events associated with any prior surgery and/or intravesical therapy must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade less than (<) 2 prior to date of randomization - Participants must be willing to undergo all study procedures
Exclusion Criteria:
Presence or history of histologically confirmed, muscle invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, greater than and equal to [>=] T2)

- Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder (that is, urethra, ureter, or renal pelvis). Ta/any T1/CIS of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to randomization

- Presence of any bladder or urethral anatomic feature (example, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of TAR-200 or administration of intravesical BCG. 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 (mL)

- Indwelling catheters are not permitted; however, intermittent catheterization is acceptable

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Janssen Research & Development, LLC Clinical Trial

Role: Study Director

Affiliation: Janssen Research & Development, LLC

Overall Contact

Name: Janssen Research & Development, LLC Clinical Trial

Phone: 844-434-4210

Email: Participate-In-This-Study@its.jnj.com

LOCATION

Facility Status Contact
Facility: Centers for Advanced Urology, LLC; d/b/a MidLantic Urology
Bala-Cynwyd, Pennsylvania 19004
United States
Status: Recruiting Contact: N/A
Facility: Centro Urologico Profesor Bengio
Cordoba, X5000KPH
Argentina
Status: Recruiting Contact: N/A
Facility: Centre Hospitalier de l'Ardenne
Libramont-Chevigny, 6800
Belgium
Status: Recruiting Contact: N/A
Facility: Fakultni nemocnice u sv. Anny v Brne
Brno, 65691
Czechia
Status: Recruiting Contact: N/A
Facility: Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
Czechia
Status: Recruiting Contact: N/A
Facility: Chonnam National University Hwasun Hospital
Jeollanam-do, 58128
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Korea University Anam Hospital
Seoul, 02841
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Seoul National University Hospital
Seoul, 03080
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Samsung Medical Center
Seoul, 06351
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, 06591
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Severance Hospital, Yonsei University Health System
Seoul, 3722
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15-276
Poland
Status: Recruiting Contact: N/A
Facility: IN VIVO Sp. z o.o
Bydgoszcz, 85-048
Poland
Status: Recruiting Contact: N/A
Facility: Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ
Lublin, 20-708
Poland
Status: Recruiting Contact: N/A
Facility: Centrum Medyczne
Piotrkow Trybunalski, 97-300
Poland
Status: Recruiting Contact: N/A
Facility: Clinical Research Center sp. z o.o MEDIC-R s.k.
Poznan, 61-731
Poland
Status: Recruiting Contact: N/A
Facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka,
Slupsk, 76-200
Poland
Status: Recruiting Contact: N/A
Facility: Provita Poliklinika
Warszawa, 02-647
Poland
Status: Recruiting Contact: N/A
Facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, 50-556
Poland
Status: Recruiting Contact: N/A
Facility: Hosp. Univ. A Coruña
A Coruña, 15006
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Virgen de La Victoria
Málaga, 29010
Spain
Status: Recruiting Contact: N/A
Facility: Taipei Veterans General Hospital
Taipei, 11217
Taiwan
Status: Recruiting Contact: N/A