Purpose

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.

Condition

Eligibility

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

Inclusion Criteria

  • Histologically confirmed diagnosis of persistent or recurrent high-risk, Non-muscle Invasive Bladder Cancer (HR-NMIBC) (carcinoma in situ [CIS]; Tumour in situ [Tis]), with or without papillary disease (T1, high-grade Ta) within 12 months of completion (last dose) of adequate Bacillus Calmette-Guerin (BCG) therapy. Mixed histology tumours are allowed if urothelial differentiation (transitional cell histology) is predominant (example, less than (<) 20 percent (%) variant histologic subtype). 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) - Visible papillary disease must be fully resected (absent) prior to randomization (residual CIS acceptable) and documented at screening cystoscopy - 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 doses of an induction course (adequate induction) plus 2 of 3 doses of a maintenance course, or 2 of 6 doses of a second induction course - Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2

Exclusion Criteria

  • 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 nephrouretrectomy more than 24 months prior to initiating study - Participants with an active, known or suspected autoimmune disease. Participants with autoimmune disorders not requiring systemic treatment (example, skin conditions such as vitiligo, psoriasis, alopecia) or conditions requiring hormonal replacement therapies such as type 1 diabetes mellitus or hypothyroidism are permitted to enroll - 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1: TAR-200 and Cetrelimab
TAR-200 is placed into the bladder through a urinary placement catheter on Day 0 and will be dosed every 21 days for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Study Year 2). In addition, Cetrelimab will be dosed every 3 weeks (Q3W) through Week 78 (18 months).
  • Drug: TAR-200
    TAR-200 will be administered transuretherally.
    Other names:
    • JNJ-17000139
    • Gemcitabine-Releasing Intravesical System
  • Biological: Cetrelimab
    Cetrelimab will be administered.
    Other names:
    • JNJ-63723283
Experimental
Cohort 2: TAR-200
TAR-200 is placed into the bladder through a urinary placement catheter on Day 0 and will be dosed every 21 days for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Study Year 2).
  • Drug: TAR-200
    TAR-200 will be administered transuretherally.
    Other names:
    • JNJ-17000139
    • Gemcitabine-Releasing Intravesical System
Experimental
Cohort 3: Cetrelimab
Participants will receive Cetrelimab which will be dosed Q3W through Week 78 (18 months).
  • Biological: Cetrelimab
    Cetrelimab will be administered.
    Other names:
    • JNJ-63723283

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
JNJ.CT@sylogent.com

Detailed Description

Bladder cancer is the tenth most common type of cancer worldwide. The natural history of high-risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC) is unpredictable; rates of recurrence vary from 15 percent (%) to 78%, and rates of progression to muscle invasion and metastasis vary from less than (<) 1 to 45%. The TAR-200/gemcitabine (JNJ-17000139-AAC) intravesical delivery system (hereafter, TAR-200) is an investigational product that is comprised of a drug and device components. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds PD-1. This study consists 3 periods: screening phase (up to 42 days); treatment phase (up to 2 years); follow up phase (up to 5 years). Total duration of study is up to 5 years. Efficacy, safety, pharmacokinetics (PK), and biomarkers will be assessed at specified time points during this study.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.