> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-tar-200-in-combination-with-cetrelimab-or-tar-200-c2d24d0f-7d72-4524-afd5-aba625ff2bc7 > Record changed: 2026-10-13 # A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC) NCT05714202 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) Participants 1,135 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) Lead sponsor Janssen Research & Development, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) Start date 2023-03-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) Number of sites 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) ## Title and summary **Summary** The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) **Acronym** SunRISe-3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) **Short title** A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) **Official title** A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and Safety of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) ## Dates **Completion date** 2029-09-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) **First posted** 2023-02-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) **Registry last updated** 2026-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) **Primary completion date** 2029-09-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) **Start date** 2023-03-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) ## Size and sites **Actual participants** 1,135 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) **Participants** 1,135 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) **Number of sites** 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) **Lead sponsor** Janssen Research & Development, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) ## Identifiers **Registry ID** NCT05714202 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) **ClinicalTrials.gov ID** NCT05714202 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) ## Outcomes ### Primary outcomes 1. Event-free Survival (EFS) Timeframe: Up to 5 years 2 months EFS is defined as the time from randomization to either the time of the first recurrence of high-risk disease, progression, or death due to any cause, whichever occurs first. For participants with carcinoma In-situ (CIS), persistent disease at 6 months (Week 24) is also considered an EFS event. Progression is defined as: an increase of stage from Ta to T1 or from CIS to T1 or progression to muscle invasive bladder cancer (MIBC) (T greater than or equal to \\\[\\>=\\\] 2) or to lymph node (N+) or to distant disease (M+), whichever occurs first. ### Secondary outcomes 1. Overall Complete Response (CR) Rate Timeframe: Up to 5 years 2 months Overall CR will be measured by determining the percentage of participants with CIS who have no presence of high-risk disease at 6 months. 2. Duration of CR Timeframe: Up to 5 years 2 months Duration of CR is defined from the time of first CR achieved to first evidence of recurrence, progression or death due to any cause (whichever occurs first) for participants who achieve a CR. 3. Recurrence-Free Survival (RFS) Timeframe: Up to 5 years 2 months RFS is defined as the time from randomization to the time of the first recurrence of high-risk disease, or death due to any cause, whichever occurs first. 4. Time to Progression (TTP) Timeframe: Up to 5 years 2 months TTP is defined as the time from randomization to the date of first documented evidence of disease progression or death due to disease progression, whichever occurs first. 5. Overall Survival (OS) Timeframe: Up to 5 years 2 months OS is defined as the time from randomization to death, due to any cause. 6. Cancer Specific Survival (CSS) Timeframe: Up to 5 years 2 months CSS is defined as the time from randomization to the date of death due to bladder cancer. 7. Number of Participants with Adverse Events (AEs) by Grades According to Common Terminology Criteria for Adverse Events (CTCAE) Timeframe: Up to 5 years 2 months 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. 8. Number of Participants with Adverse Events (AEs) Timeframe: Up to 5 years 2 months Number of participants with AEs will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. 9. Number of Participants with Change from Baseline in Laboratory Abnormalities Timeframe: Up to 5 years 2 months 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. 10. Number of Participants with Change from Baseline in Vital Signs Abnormalities Timeframe: Up to 5 years 2 months Number of participants with change from baseline in vital signs (blood pressure \\\[systolic and diastolic\\\], heart rate, temperature, and weight) abnormalities will be reported. 11. Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of life Questionnaire - Non-muscle Invasive Bladder Cancer EORTC QLQ- NMIBC 24 Timeframe: Up to 5 years 2 months EORTC QLQ-NMIBC 24 is a 24-item questionnaire for evaluating the Health-related quality of life (HRQoL) of participants with superficial (non-muscle-invasive) bladder cancer. The questionnaire is designed to supplement the quality of life questionnaire (QLQ-C30) and incorporates 6 multi-item scales and 5 single items. Ratings for each item range from 1 (not at all) to 4 (very much). 12. Time to Symptom Deterioration as Assessed by EORTC-QLQ-NMIBC 24 Scores Timeframe: Up to 5 years 2 months EORTC QLQ-NMIBC 24 is a 24-item questionnaire for evaluating the HRQoL of participants with superficial (non-muscle-invasive) bladder cancer. The questionnaire is designed to supplement the QLQ-C30 and incorporates 6 multi-item scales and 5 single items. Ratings for each item range from 1 (not at all) to 4 (very much). Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Histologically confirmed initial diagnosis by local pathology (within 90 days of the most recent signed informed consent) of high grade non-muscle invasive bladder cancer (HR-NMIBC) (high-grade Ta, any T1 or carcinoma in-situ \[CIS\]), in participants who are Bacillus Calmette Guérin (BCG)-naïve - BCG-naïve (participants who have not received prior intravesical BCG or who previously received but stopped BCG more than 3 years before date of randomization are eligible) - All visible papillary disease must be fully resected (absent) prior to date of randomization and documented at baseline cystoscopy. Local urine cytology at screening must be negative or atypical (for high-grade urothelial carcinoma \[HGUC\]) for patients with papillary only disease (without CIS) - Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2 - All adverse events associated with any prior surgery and/or intravesical therapy must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade less than (<) 2 prior to date of randomization - Participants must be willing to undergo all study procedures ### Exclusion criteria - Presence or history of histologically confirmed, muscle invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, greater than and equal to \[>=\] T2) - Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder (that is, urethra, ureter, or renal pelvis). Ta/any 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 - Presence of any bladder or urethral anatomic feature (example, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of TAR-200 or administration of intravesical BCG. Participants with tumors involving the prostatic urethra in men will be excluded - A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (mL) - Indwelling catheters are not permitted; however, intermittent catheterization is acceptable Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) ## Sites - Mayo ClinicScottsdale, United States - Arkansas UrologyLittle Rock, United States - VA Long Beach Health Care SystemLong Beach, United States - Genesis Research, LLC - West Coast UrologyLos Alamitos, United States - Cedars Sinai Medical CenterLos Angeles, United States - UC Davis Comprehensive Cancer CenterSacramento, United States - Genesis ResearchSan Diego, United States - Providence Saint Johns Cancer InstituteSanta Monica, United States - Providence Medical FoundationSanta Rosa, United States - Colorado Clinical ResearchLakewood, United States - Urological Research NetworkHialeah, United States - Orlando Health Cancer InstituteOrlando, United States - Sarasota Memorial HospitalSarasota, United States - Grady Memorial HospitalAtlanta, United States - The Emory Clinic Department of UrologyAtlanta, United States - Northwestern UniversityChicago, United States - Duly Health and CareLisle, United States - Blessing HospitalQuincy, United States - Urology of IndianaCarmel, United States - First UrologyJeffersonville, United States - AMR Kansas City OncologyMerriam, United States - Wichita Urology GroupWichita, United States - Chesapeake Urology Research AssociatesHanover, United States - Lahey Hospital & Medical CenterBurlington, United States - University of MichiganAnn Arbor, United States And 215 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) ## References ### Other registry identifiers (4) - 2023 - 2023-507187-39-00 - 2020-004506-64 - 17000139BLC3002 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05714202) ## Related records ### Drugs (1) - [Cetrelimab](https://trialight.com/data/asset/cetrelimab-3efc0fa4-bffb-4b48-bdc8-d69f58f2bb03.md) ### Lead sponsors (1) - [Janssen Research & Development, LLC](https://trialight.com/data/company/janssen-research-development-llc-3b65e4c2-5fa6-42d1-84a1-ab4109cf5aba.md) ### Conditions (2) - [Stage IVb bladder cancer](https://trialight.com/data/condition/stage-ivb-bladder-cancer-e9ea4ec3-75ca-5cf5-979c-43f16309cdba.md) Primary condition - [Urinary bladder neoplasm](https://trialight.com/data/condition/urinary-bladder-neoplasm-269fb796-5527-5895-bad6-63dc153c3401.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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