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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04919512
Recruitment Status : Not yet recruiting
First Posted : June 9, 2021
Last Update Posted : April 22, 2022
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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
Urinary Bladder Neoplasms Drug: TAR-200 Biological: Cetrelimab 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : April 28, 2022
Estimated Primary Completion Date : April 10, 2023
Estimated Study Completion Date : September 22, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

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 Name: JNJ-17000139

Biological: Cetrelimab
Cetrelimab will be administered.
Other Name: JNJ-63723283

Experimental: Cohort 2: Cetrelimab
Participants will receive cetrelimab.
Biological: Cetrelimab
Cetrelimab will be administered.
Other Name: JNJ-63723283

Primary Outcome Measures :
  1. Percentage of Participants with Pathologic Complete Response (pCR) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04919512

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Contact: Study Contact 844-434-4210

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Sponsors and Collaborators
Janssen Research & Development, LLC
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
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Responsible Party: Janssen Research & Development, LLC Identifier: NCT04919512    
Other Study ID Numbers: CR109044
2020-005565-13 ( EudraCT Number )
17000139BLC2002 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: June 9, 2021    Key Record Dates
Last Update Posted: April 22, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Transitional Cell
Urinary Bladder Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases