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Brief Title: TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guerin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin (BCG) Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

INTRODUCTION

  • Org Study ID: CR108921
  • Secondary ID: N/A
  • NCT ID: NCT04640623
  • Sponsor: Janssen Research & Development, LLC

BRIEF SUMMARY

The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease; and disease-free survival (DFS) in participants treated with TAR-200 alone with papillary disease only (Cohort 4).

  • Overall Status
    Recruiting
  • Start Date
    December 18, 2020
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Urinary Bladder Neoplasms

ELIGIBILITY

Inclusion Criteria:
* Histologically confirmed diagnosis of persistent or recurrent high-risk non-muscle invasive bladder cancer (HR-NMIBC), (carcinoma in situ [CIS] or tumor in situ [Tis]), with or without papillary disease (T1, high-grade Ta) or papillary disease only (high-grade Ta or any T1 and absence of CIS), within 12 months of completion of the last dose of Bacillus Calmette-Guerin (BCG) therapy, in participants who have received adequate BCG. 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. For participants with lamina propria invasion (T1) on the screening biopsy/ transurethral resection of bladder tumor (TURBT), muscularis propria must be present in order to rule out Muscle Invasive Bladder Cancer (MIBC)

- * All visible papillary disease must be fully resected (absent) prior to randomization (residual CIS is acceptable for participants eligible for Cohorts 1, 2, and 3 only) and documented in the electronic case report form (eCRF) at screening cystoscopy. For participants with papillary disease only (Cohort 4), local urine cytology at screening must be negative or atypical (for High-Grade Urothelial Carcinoma [HGUC])

- * Participants must be ineligible for or have elected not to undergo radical cystectomy

- * BCG-unresponsive high-risk NMIBC after treatment with adequate BCG therapy defined as a minimum of 5 of 6 full doses of an induction course (adequate induction) plus 2 of 3 doses of a maintenance course, or at least 2 of 6 doses of a second induction course

- * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
Exclusion Criteria:
* Presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, and/or Stage IV)

- * Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder. Ta/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

- * Received a live virus vaccine within 30 days prior to the initiation of study treatment. Inactivated (non-live or non-replicating) vaccines approved or authorized for emergency use (for example, COVID-19) by local health authorities are allowed

- * Active hepatitis B or C infection (for example, participants with history of hepatitis C infection but undetectable hepatitis C virus polymerase chain reaction (PCR) test and participants with history of hepatitis B infection with positive hepatitis B surface antigen (HBsAg) antibody and undetectable PCR are allowed)

- * Prior therapy with an anti-programmed-cell death 1 (PD-1), anti-PD-ligand 2 (L2) agent, or with an agent directed to another co-inhibitory T-cell receptor

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: Study Contact

Phone: 844-434-4210

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

LOCATION

Facility Status Contact
Facility: Urological Associates of Southern Arizona, P.C.
Tucson, Arizona 85715
United States
Status: Recruiting Contact: N/A
Facility: University of Southern California
Los Angeles, California 90033
United States
Status: Recruiting Contact: N/A
Facility: Genesis Healthcare Partners - Genesis Research Greater Los Angeles
Sherman Oaks, California 91411
United States
Status: Recruiting Contact: N/A
Facility: Foothills Urology - Golden Off
Golden, Colorado 80401
United States
Status: Recruiting Contact: N/A
Facility: DuPage Medical Group
Lisle, Illinois 60532
United States
Status: Recruiting Contact: N/A
Facility: Urology of Indiana
Greenwood, Indiana 46143
United States
Status: Recruiting Contact: N/A
Facility: Michigan Institute of Urology
Troy, Michigan 48084
United States
Status: Recruiting Contact: N/A
Facility: NYU Langone Health
New York, New York 10017
United States
Status: Recruiting Contact: N/A
Facility: SUNY Upstate Medical University
Syracuse, New York 13210-2375
United States
Status: Recruiting Contact: N/A
Facility: Associated Medical Professionals
Syracuse, New York 13210
United States
Status: Recruiting Contact: N/A
Facility: Levine Cancer Institute
Charlotte, North Carolina 28204
United States
Status: Recruiting Contact: N/A
Facility: The Urology Group
Cincinnati, Ohio 45212
United States
Status: Recruiting Contact: N/A
Facility: Urologic Consultants of Southeastern Pennsylvania
Bala-Cynwyd, Pennsylvania 19004
United States
Status: Recruiting Contact: N/A
Facility: Urology Associates, PC
Nashville, Tennessee 37209
United States
Status: Recruiting Contact: N/A
Facility: Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Status: Recruiting Contact: N/A
Facility: Urology Austin
Austin, Texas 78745
United States
Status: Recruiting Contact: N/A
Facility: University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
Status: Recruiting Contact: N/A
Facility: Urology San Antonio Research
San Antonio, Texas 78229
United States
Status: Recruiting Contact: N/A