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SunRISe-4: A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04919512
Collaborator
(none)
160
Enrollment
93
Locations
2
Arms
39.6
Anticipated Duration (Months)
1.7
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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-AAC) 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Jun 6, 2022
Anticipated Primary Completion Date :
Apr 10, 2023
Anticipated Study Completion Date :
Sep 22, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1: TAR-200 + Cetrelimab

Participants will receive TAR-200 in combination with cetrelimab.

Drug: TAR-200
TAR-200 will be administered.
Other Names:
  • JNJ-17000139

    • Biological: Cetrelimab
    Cetrelimab will be administered.
    Other Names:
  • JNJ-63723283

    		•
    Experimental: Cohort 2: Cetrelimab

    Participants will receive cetrelimab.

    Biological: Cetrelimab
    Cetrelimab will be administered.
    Other Names:
  • JNJ-63723283

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants with Pathologic Complete Response (pCR) [Up to Week 15]

      Percentage of participants with a pathologic complete response (pCR) or no evidence of pathologic intravesical disease and nodal involvement (ypT0N0) derived from analysis of radical cystectomy (RC) bladder specimen will be reported.

    Secondary Outcome Measures

    1. Recurrence-Free Survival (RFS) [Up to Week 108]

      RFS is defined as the time from randomization to first radiologic (as assessed by response evaluation criteria in solid tumors [RECIST] 1.1 criteria) or histologic evidence of nodal or metastatic disease or death due to any cause.

    2. Number of Participants with Adverse Events (AEs) by Grades According to Common Terminology Criteria for Adverse Events (CTCAE) [Up to Week 108]

      Number of participants with AEs by severity grade as assessed by CTCAE version 5 will be reported. Grade refers to the severity of AE as follows: Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5- Death related to adverse event.

    3. Number of Participants with Change from Baseline in Laboratory Abnormalities [Up to Week 108]

      Number of participants with change from baseline in laboratory abnormalities will be reported. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    • 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 randomization

    Exclusion Criteria:

    • Must not have received prior systemic chemotherapy, targeted small molecule therapy, or radiation therapy within 2 years 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Duarte California United States 91010
    2 University of California Irvine Medical Center Orange California United States 92868
    3 The Urology Center of Colorado Denver Colorado United States 80211
    4 University of Florida Jacksonville Florida United States 32209
    5 Baptist Hospital of Miami Miami Florida United States 33176
    6 DuPage Medical Group Lisle Illinois United States 60532
    7 Michigan Institute of Urology, PC Troy Michigan United States 48084
    8 Minnesota Urology Woodbury Minnesota United States 55125
    9 Ellis Fischel Cancer Center Columbia Missouri United States 65201
    10 New Jersey Urology LLC Voorhees New Jersey United States 08043
    11 Albany Medical Center Albany New York United States 12208
    12 Montefiore Medical Center Bronx New York United States 10467
    13 SUNY Upstate Medical University Syracuse New York United States 13202
    14 Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center Winston-Salem North Carolina United States 27103
    15 The Ohio State University Columbus Ohio United States 43210
    16 Oregon Urology Institute Springfield Oregon United States 97477
    17 MidLantic Urology Bala-Cynwyd Pennsylvania United States 19004
    18 Sidney Kimmel Cancer Center - Jefferson Health Philadelphia Pennsylvania United States 19107
    19 Carolina Urologic Research Center Myrtle Beach South Carolina United States 29572
    20 Urology Associates Nashville Tennessee United States 37209
    21 The University of Texas MD Anderson Cancer Center Houston Texas United States 77030
    22 Urology San Antonio Research San Antonio Texas United States 78229
    23 Huntsman Cancer Institute Salt Lake City Utah United States 84112
    24 Spokane Urology Spokane Washington United States 99202
    25 AZ Sint-Jan Brugge-Oostende AV Brugge Belgium 8000
    26 Algemeen Ziekenhuis Sint-Jan Brugge Belgium 8310
    27 Ziekenhuis Oost-Limburg Genk Belgium 3600
    28 Hopital de Jolimont Haine-saint-paul, LA Louviere Belgium 7100
    29 ZNA Jan Palfijn Merksem Belgium 2170
    30 Centre Interuniversitaire Ambroise Pare - Ambroise Paré Mons Belgium 7000
    31 Algemeen Ziekenhuis Delta Roeselare Belgium 8800
    32 CHU Amiens Picardie Amiens France 80000
    33 Centre Hospitalier de la Cote Basque Bayonne France 64100
    34 Clinique Tivoli Ducos Bordeaux France 33000
    35 ICH Hopital A. Morvan Brest France 29200
    36 Hopital Henri Mondor Creteil France 94000
    37 Hôpital Privé Le Bois Lille France 59000
    38 Polyclinique de Limoges - Francois Chenieux Limoges France 87000
    39 Hopital de la Timone Marseille France 13005
    40 CHU Nîmes Nimes France 30029
    41 Hopital Bichat Claude Bernard Paris Cedex 18 France 75877
    42 Hopital Europeen Georges-Pompidou Paris France 75015
    43 Hospices Civils de Lyon HCL Pierre Bénite France 69495
    44 HIA se Sainte-Anne - Toulon Toulon France 83041
    45 Clinique Pasteur Toulouse France 31076
    46 Vivantes Klinikum Am Urban Berlin-Kreuzberg Germany 10967
    47 Staedtisches Klinikum Braunschweig Braunschweig Germany 38118
    48 Städtisches Klinikum Dessau Dessau-Roßlau Germany 06846
    49 Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus Frankfurt am Main Germany 60431
    50 Marien hospital Herne Herne Germany 44625
    51 Universitätsklinikum Münster Muenster Germany 48149
    52 Klinikum St. Elisabeth Straubing Germany 94315
    53 Universitätsklinikum Tübingen Tübingen Germany 72076
    54 Universitätsklinikum Würzburg Wurzburg Germany 97080
    55 Rambam Health Care Campus Haifa Israel 3109601
    56 Carmel Medical Center Haifa Israel 3436212
    57 Hadassah Medical Center Jerusalem Israel 91120
    58 The Chaim Sheba Medical Center Ramat Gan Israel 52621
    59 Tel Aviv Sourasky Medical Center Tel Aviv Israel 6423906
    60 Ospedale San Giuseppe Moscati di Avellino Avellino Italy 83100
    61 Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Bari Italy 70120
    62 Ospedale Civile Ramazzini Carpi Italy 41012
    63 SPDC Villa Scassi Genova Italy 16100
    64 IRCCS Ospedale San Raffaele Milano Italy 20132
    65 Istituto Europeo di Oncologia Milano Italy 20141
    66 Istituto Nazionale Tumori Fondazione G. Pascale Napoli Italy 80131
    67 Azienda Ospedaliero Universitaria Pisana Pisa Italy 56126
    68 ASL Napoli 2 Nord-SM delle Grazie Hospital Pozzuoli Italy 80078
    69 Istituto Nazionale Tumori Regina Elena Roma Italy 00144
    70 Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino Torino Italy 10126
    71 Inje University Haeundae Paik Hospital Busan Korea, Republic of 612-030
    72 Kyungpook National University Chilgok Hospital Daegu Korea, Republic of 41404
    73 Keimyung University Dongsan Hospital Daegu Korea, Republic of 42601
    74 National Cancer Center Goyang-Si Korea, Republic of 10408
    75 Korea University Anam Hospital Seoul Korea, Republic of 02841
    76 Seoul National University Hospital Seoul Korea, Republic of 03080
    77 Severance Hospital Seoul Korea, Republic of 03722
    78 Gangnam Severance Hospital Seoul Korea, Republic of 06273
    79 The Catholic University of Korea, Seoul St. Mary's Hospital Seoul Korea, Republic of 06591
    80 Pusan National University Yangsan Hospital Yangsan Korea, Republic of 50612
    81 Ziekenhuisgroep Twente Almelo Netherlands 7600
    82 Haga ziekenhuis Den Haag Netherlands 2545 AA
    83 Fundacion Puigvert Barcelona Spain 08041
    84 Hosp. Univ. San Cecilio Granada Spain 18016
    85 Clinica Univ. de Navarra Madrid Spain 28027
    86 Hosp. Clinico San Carlos Madrid Spain 28040
    87 Hospital Universitario 12 de Octubre Madrid Spain 28041
    88 Hosp. Virgen de La Victoria Málaga Spain 29010
    89 Hosp. Univ. Marques de Valdecilla Santander Spain 39002
    90 NHS Greater Glasgow and Clyde Glasgow United Kingdom G12 0YN
    91 Barts Health NHS Trust London United Kingdom EC1A 7BE
    92 Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital Preston United Kingdom PR2 9HT
    93 University Hospital Southampton NHS Foundation Trust Southampton United Kingdom SO166YD

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT04919512
    Other Study ID Numbers:
    • CR109044
    • 2020-005565-13
    • 17000139BLC2002
    First Posted:
    Jun 9, 2021
    Last Update Posted:
    May 20, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma, Transitional Cell
    Urinary Bladder Neoplasms

    Study Results

    No Results Posted as of May 20, 2022