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Brief Title: A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder

A Phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Scheduled for Radical Cystectomy and Are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy

INTRODUCTION

  • Org Study ID: CR109044
  • Secondary ID: 2020-005565-13, 17000139BLC2002
  • NTC ID: NCT04919512
  • Sponsor: Janssen Research & Development, LLC

BRIEF SUMMARY

The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination with intravenous (IV) cetrelimab and IV cetrelimab alone.

DETAILED DESCRIPTION

Bladder cancer is the tenth most common malignancy worldwide. Approximately 25 percent (%) of all new bladder cancer participants present with muscle invasive bladder cancer (MIBC) at the time of diagnosis, and roughly 50% will ultimately develop distant metastases. The TAR-200/ gemcitabine (JNJ-17000139) product is an intravesical drug delivery system regulated as an investigational drug. The drug constituent consists of gemcitabine minitablets 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 standard of care in MIBC includes radical cystectomy (RC) with urinary diversion and is considered the preferred treatment option for participants who are considered surgical candidates. Study consists of a Screening phase, Treatment phase and follow-up phase. The total duration of study will be up to 2 years and 6 months. Efficacy, safety, pharmacokinetics (PK), and biomarkers will be assessed at specific time points during this study.

  • Overall Status
    Recruiting
  • Start Date
    July 7, 2022
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Percentage of Participants with Pathologic Complete Response (pCR)

Primary Outcome 1 - Timeframe: Up to Week 15

CONDITION

  • Urinary Bladder Neoplasms

ELIGIBILITY

Inclusion Criteria:
Histologically proven, cT2-T4a N0, M0 infiltrating urothelial carcinoma of the bladder. Initial diagnosis must have been within 90 days of randomization date. Participants with variant histologic subtypes (example squamous differentiation) are allowed if urothelial (transitional cell) differentiation is predominant (example, less than [<]20 percent [%] variant histologic subtype). However, the presence of any neuroendocrine, micropapillary, signet ring cell, plasmacytoid, or sarcomatoid features will make a participant ineligible - Participants with an individual intravesical tumor size of less than or equal to <=3 centimeter (cm) following transurethral resection of bladder tumor (TURBT) are eligible. Participants with persistent multifocal tumors at screening must undergo a second debulking, re-staging TURBT to reduce the tumor burden. Participants will be ineligible if any individual tumor is greater than (>)3 cm

- Deemed eligible for and willing to undergo RC by the operating urologist

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

- Thyroid function tests within normal range or stable on hormone supplementation per investigator assessment. Investigators may consult an endocrinologist for participant eligibility assessment in the case of equivocal or marginal tests results

- All adverse events associated with any prior surgery must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade less than (<) 2 prior to date of randomization
Exclusion Criteria:
Must not have received prior systemic chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to starting study treatment

- Participants must not have evidence of cT4b, or N1-3, or M1 disease based on local radiology staging (chest, abdomen, and pelvis must be performed using computed tomography [CT] or magnetic resonance imaging [MRI]) within 42 days prior to randomization

- 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-200

- Prior systemic chemotherapy for urothelial cell carcinoma of the bladder at any time

- Currently participating or has participated in a study of an investigational agent and received study therapy or investigational device within 4 weeks prior to enrollment

- Participants with evidence of bladder perforation during diagnostic cystoscopy. Participant is eligible if perforation has resolved prior to dosing

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: City of Hope
Duarte, California 91010
United States
Status: Recruiting Contact: N/A
Facility: Colorodo Urology- St. Anthony Hospital
Golden, Colorado 80401
United States
Status: Recruiting Contact: N/A
Facility: University of Florida
Jacksonville, Florida 32209
United States
Status: Recruiting Contact: N/A
Facility: Baptist Hospital of Miami
Miami, Florida 33176
United States
Status: Recruiting Contact: N/A
Facility: Ellis Fischel Cancer Center
Columbia, Missouri 65201
United States
Status: Recruiting Contact: N/A
Facility: Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center
Winston-Salem, North Carolina 27103
United States
Status: Recruiting Contact: N/A
Facility: Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States
Status: Recruiting Contact: N/A
Facility: Urology Associates
Nashville, Tennessee 37209
United States
Status: Recruiting Contact: N/A
Facility: Urology San Antonio Research
San Antonio, Texas 78229
United States
Status: Recruiting Contact: N/A
Facility: Huntsman Cancer Institute
Salt Lake City, Utah 84112
United States
Status: Recruiting Contact: N/A
Facility: AZ Sint-Jan Brugge-Oostende AV
Brugge, 8000
Belgium
Status: Recruiting Contact: N/A
Facility: Algemeen Ziekenhuis Sint-Jan
Brugge, 8310
Belgium
Status: Recruiting Contact: N/A
Facility: Hopital de Jolimont
Haine-saint-paul, LA Louviere, 7100
Belgium
Status: Recruiting Contact: N/A
Facility: ZNA Jan Palfijn
Merksem, 2170
Belgium
Status: Recruiting Contact: N/A
Facility: Centre Interuniversitaire Ambroise Pare - Ambroise Paré
Mons, 7000
Belgium
Status: Recruiting Contact: N/A
Facility: Clinique Tivoli Ducos
Bordeaux, 33000
France
Status: Recruiting Contact: N/A
Facility: Hopital Henri Mondor
Creteil, 94000
France
Status: Recruiting Contact: N/A
Facility: Hôpital Privé Le Bois
Lille, 59000
France
Status: Recruiting Contact: N/A
Facility: Polyclinique de Limoges - Francois Chenieux
Limoges, 87000
France
Status: Recruiting Contact: N/A
Facility: Hopital de la Timone
Marseille, 13005
France
Status: Recruiting Contact: N/A
Facility: CHU Nîmes
Nimes, 30029
France
Status: Recruiting Contact: N/A
Facility: Hospices Civils de Lyon HCL
Pierre Bénite, 69495
France
Status: Recruiting Contact: N/A
Facility: HIA se Sainte-Anne - Toulon
Toulon, 83041
France
Status: Recruiting Contact: N/A
Facility: Ospedale San Giuseppe Moscati di Avellino
Avellino, 83100
Italy
Status: Recruiting Contact: N/A
Facility: Ospedale Civile Ramazzini
Carpi, 41012
Italy
Status: Recruiting Contact: N/A
Facility: SPDC Villa Scassi
Genova, 16100
Italy
Status: Recruiting Contact: N/A
Facility: IRCCS Ospedale San Raffaele
Milano, 20132
Italy
Status: Recruiting Contact: N/A
Facility: Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, 80131
Italy
Status: Recruiting Contact: N/A
Facility: Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
Italy
Status: Recruiting Contact: N/A
Facility: ASL Napoli 2 Nord-SM delle Grazie Hospital
Pozzuoli, 80078
Italy
Status: Recruiting Contact: N/A
Facility: Istituto Nazionale Tumori Regina Elena
Roma, 00144
Italy
Status: Recruiting Contact: N/A
Facility: Inje University Haeundae Paik Hospital
Busan, 612-030
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Kyungpook National University Chilgok Hospital
Daegu, 41404
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Keimyung University Dongsan Hospital
Daegu, 42601
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Pusan National University Yangsan Hospital
Gyeongsangnam-do, 50612
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: Severance Hospital
Seoul, 03722
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Gangnam Severance Hospital
Seoul, 06273
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: Hosp. Univ. San Cecilio
Granada, 18016
Spain
Status: Recruiting Contact: N/A
Facility: Clinica Univ. de Navarra
Madrid, 28027
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Status: Recruiting Contact: N/A
Facility: Hosp. Univ. Marques de Valdecilla
Santander, 39002
Spain
Status: Recruiting Contact: N/A