A Study of 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-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy (SunRISe-1)

  • End date
    Jul 2, 2027
  • participants needed
  • sponsor
    Janssen Research & Development, LLC
Updated on 4 April 2023
radical cystectomy
carcinoma in situ
invasive bladder cancer
transurethral resection
bladder tumor
transurethral bladder excision
intravesical bcg


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.


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 gemcitabine 225 milligrams (mg) intravesical delivery system (JNJ-17000139) product (hereafter, TAR-200) is an investigational integral 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 programmed-cell death protein 1 (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 6 year and 7 months. Efficacy, safety, pharmacokinetics (PK), and biomarkers will be assessed at specified time points during this study.

Condition Urinary Bladder Neoplasms
Treatment Cetrelimab, TAR-200
Clinical Study IdentifierNCT04640623
SponsorJanssen Research & Development, LLC
Last Modified on4 April 2023


Yes No Not Sure

Inclusion Criteria

Histologically confirmed diagnosis of persistent or recurrent (carcinoma in situ [CIS] or Tumour in situ [Tis]), with or without papillary disease (T1, high-grade Ta) 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 acceptable) and documented in the electronic case report form (eCRF) 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 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
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
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