TriangleNCT04640623 · CITED IN SOURCE DOCUMENTS
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
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE2
- Status at capture
- ACTIVE NOT RECRUITING
- Registry last update
- 2026-08-28
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; and disease-free survival (DFS) in participants treated with TAR-200 alone with papillary disease only (Cohort 4).
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Cohorts 1, 2, and 3: Overall Complete Response (CR) Rate
Cohort 4: Disease-free Survival (DFS)
Cohorts 1, 2, and 3: Number of Participants With at Least 12 Months Duration of Response
Overall Survival (OS)
Cohorts 1, 2, and 4: Plasma Concentrations of Gemcitabine and 2',2' Difluorodeoxyuridine (dFdU) (Metabolite)
Cohorts 1 and 2: Maximum Observed Urine Concentration (Cmax) of Gemcitabine and dFdU (Metabolite)
Cohort 4: Urine Concentration of Gemcitabine and dFdU (Metabolite)
Cohort 1and 3: Serum Concentration of Cetrelimab
Cohort 3: Serum Concentration of Cetrelimab
Cohorts 1 and 3: Number of Participants With Anti-cetrelimab Antibodies
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ) -C30 Scores
Change From Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores
Time to Symptom Deterioration as Assessed by European Organisation for Research and Treatment of Cancer Qualityof-life Questionnaire (EORTC QLQ) -C30 Scores
Time to Symptom Deterioration as Assessed by EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores
Number of Participants With Adverse Events (AEs) by Severity Grades
Number of Participants With Clinical Laboratory Abnormalities by Severity Grades
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Histologically confirmed diagnosis of persistent or recurrent high-risk non-muscle invasive bladder cancer (HR-NMIBC), (carcinoma in situ \[CIS\] or tumor in situ \[Tis\]), with or without papillary disease (T1, high-grade Ta) or papillary disease only (high-grade Ta or any T1 and absence of CIS), 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 is acceptable for participants eligible for Cohorts 1, 2, and 3 only) and documented in the electronic case report form (eCRF) at screening cystoscopy. For participants with papillary disease only (Cohort 4), local urine cytology at screening must be negative or atypical (for High-Grade Urothelial Carcinoma \[HGUC\]) * 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 * Received a live virus vaccine within 30 days prior to the initiation of study treatment. Inactivated (non-live or non-replicating) vaccines approved or authorized for emergency use (for example, COVID-19) by local health authorities are allowed * 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- TAR-200 is placed into the bladder through a urinary placement catheter in participants with carcinoma in situ (CIS), with or without papillary disease, on Day 0 and will be dosed every 3 weeks (Q3W) for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2). In addition, Cetrelimab will be dosed Q3W through Week 78 (18 months).
- intervention Names
- Drug: TAR-200
- Biological: Cetrelimab
- label
- Cohort 1: TAR-200 and Cetrelimab
- type
- EXPERIMENTAL
- description
- TAR-200 is placed into the bladder through a urinary placement catheter in participants with CIS, with or without papillary disease, on Day 0 and will be dosed Q3W for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2).
- intervention Names
- Drug: TAR-200
- label
- Cohort 2: TAR-200
- type
- EXPERIMENTAL
- description
- Participants with CIS, with or without papillary disease, will receive Cetrelimab which will be dosed Q3W through Week 78 (18 months).
- intervention Names
- Biological: Cetrelimab
- label
- Cohort 3: Cetrelimab
- type
- EXPERIMENTAL
- description
- TAR-200 is placed into the bladder through a urinary placement catheter in participants with papillary disease only, on Day 0 and will be dosed Q3W for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2).
- intervention Names
- Drug: TAR-200
- label
- Cohort 4: TAR-200 (Participants with Papillary Disease only)
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Cohort 1: TAR-200 and Cetrelimab
- Cohort 2: TAR-200
- Cohort 4: TAR-200 (Participants with Papillary Disease only)
- description
- TAR-200 will be administered transuretherally.
- name
- TAR-200
- other Names
- JNJ-17000139
- Gemcitabine-Releasing Intravesical System
- type
- DRUG
- arm Group Labels
- Cohort 1: TAR-200 and Cetrelimab
- Cohort 3: Cetrelimab
- description
- Cetrelimab will be administered.
- name
- Cetrelimab
- other Names
- JNJ-63723283
- type
- BIOLOGICAL
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 220
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Overall CR rate was defined as the percentage of participants who met at least one of the following: negative cystoscopy and negative (including atypical) centrally read urine cytology, or positive cystoscopy with biopsy-proven benign or low-grade non-muscle invasive bladder cancer (NMIBC) and negative (including atypical) centrally read cytology at any time point.
- measure
- Cohorts 1, 2, and 3: Overall Complete Response (CR) Rate
- time Frame
- From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
- description
- DFS was defined as the time from the date of first dose of study treatment to the time of one of the following events, whichever occurred first: (1) The first recurrence of high-risk disease (high-grade Ta, any T1 or CIS), (2) 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 occurred first, (3) Death due to any cause.
- measure
- Cohort 4: Disease-free Survival (DFS)
- time Frame
- From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
- secondary Outcomes
- description
- DOR was defined as the date of first complete response (CR) achieved to the date of first evidence of recurrence or progression or death, using cystoscopy, centrally read bladder biopsy and urine cytology, and imaging, if available. Complete response was defined as having a negative cystoscopy and negative (including atypical) centrally assessed urine cytology, or positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative (including atypical) centrally assessed cytology at any time point. Number of participants with at least 12 months duration of response were reported.
- measure
- Cohorts 1, 2, and 3: Number of Participants With at Least 12 Months Duration of Response
- time Frame
- From onset of first CR up to clinical cut-off date 3rd July 2025 (up to 47.3 months)
- measure
- Overall Survival (OS)
- time Frame
- From Week 0 up to 6 years 7 months
- description
- Plasma concentrations of gemcitabine and dFdU were reported.
- measure
- Cohorts 1, 2, and 4: Plasma Concentrations of Gemcitabine and 2',2' Difluorodeoxyuridine (dFdU) (Metabolite)
- time Frame
- Predose at Week 0 and at any time between Days 2-7 during Weeks 3, 6, 9, 15, 18, and 21 postdose
- description
- Cmax was defined as maximum observed urine concentration.
- measure
- Cohorts 1 and 2: Maximum Observed Urine Concentration (Cmax) of Gemcitabine and dFdU (Metabolite)
- time Frame
- At Week 0
- description
- Urine concentrations of gemcitabine and dFdU were reported.
- measure
- Cohort 4: Urine Concentration of Gemcitabine and dFdU (Metabolite)
- time Frame
- At Weeks 3, 6, 9, 15, 18, and 21
- description
- Serum concentration of cetrelimab were reported.
- measure
- Cohort 1and 3: Serum Concentration of Cetrelimab
- time Frame
- At Weeks 0, 3, 12, 24, 48, 60, 84 (end of infusion) [EOI]
- description
- Serum concentration of cetrelimab were reported.
- measure
- Cohort 3: Serum Concentration of Cetrelimab
- time Frame
- At Weeks 60 (EOI)
- description
- Number of participants positive to anti-cetrelimab antibodies was reported using validated immunoassay for anti-drug antibody (ADA) analysis.
- measure
- Cohorts 1 and 3: Number of Participants With Anti-cetrelimab Antibodies
- time Frame
- From date of first dose up to clinical cut-off date 3rd July 2025 (54 months)
- measure
- Change From Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ) -C30 Scores
- time Frame
- From Week 0 up to 6 years 7 months
- measure
- Change From Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores
- time Frame
- From Week 0 up to 6 years 7 months
- measure
- Time to Symptom Deterioration as Assessed by European Organisation for Research and Treatment of Cancer Qualityof-life Questionnaire (EORTC QLQ) -C30 Scores
- time Frame
- From Week 0 up to 6 years 7 months
- measure
- Time to Symptom Deterioration as Assessed by EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores
- time Frame
- From Week 0 up to 6 years 7 months
Full study description
- brief Summary
- 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; and disease-free survival (DFS) in participants treated with TAR-200 alone with papillary disease only (Cohort 4).
Source references
- references
- citation
- Daneshmand S, Van der Heijden MS, Jacob JM, Guerrero-Ramos F, Bogemann M, Simone G, Pieczonka CM, Casco NC, Zainfeld D, Spiegelhalder P, Xylinas E, Cahn D, Lotan Y, Murray KS, Kawahara T, Stromberg K, Martin J, Shukla A, Cutie CJ, Bertzos K, Hampras S, Sweiti H, Necchi A; SunRISe-1 Study. TAR-200 for Bacillus Calmette-Guerin-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer: Results From the Phase IIb SunRISe-1 Study. J Clin Oncol. 2025 Nov 20;43(33):3578-3588. doi: 10.1200/JCO-25-01651. Epub 2025 Jul 30.
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Source notices and limitations
Discovery and provenance
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Preserved source evidence · Independent clinical review pending · Not medical advice