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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05714202




Registration number
NCT05714202
Ethics application status
Date submitted
27/01/2023
Date registered
6/02/2023
Date last updated
29/10/2024

Titles & IDs
Public 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)
Scientific 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
Secondary ID [1] 0 0
2020-004506-64
Secondary ID [2] 0 0
CR109223
Universal Trial Number (UTN)
Trial acronym
SunRISe-3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bladder Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bladder - transitional cell cancer
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TAR-200
Treatment: Other - Cetrelimab
Treatment: Other - BCG Vesiculture

Experimental: Treatment Group A: TAR-200 + Cetrelimab - Participants will receive intravesical TAR-200 once every 3 weeks (Q3W) and cetrelimab.

Active comparator: Treatment Group B: Bacillus Calmette-Guerin (BCG) Vesiculture - Participants will receive intravesical BCG once every week for 6 weeks (induction) and then followed by once every week for 3 weeks starting at Weeks 12, 24, 48, 72, and 96 (maintenance).

Experimental: Treatment Group C: TAR-200 Alone - Participants will receive intravesical TAR-200 alone once Q3W.


Treatment: Drugs: TAR-200
TAR-200 will be administered intravesically.

Treatment: Other: Cetrelimab
Cetrelimab will be administered.

Treatment: Other: BCG Vesiculture
BCG will be administered intravesically.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event-free Survival (EFS)
Timepoint [1] 0 0
Up to 5 years 2 months
Secondary outcome [1] 0 0
Overall Complete Response (CR) Rate
Timepoint [1] 0 0
Up to 5 years 2 months
Secondary outcome [2] 0 0
Duration of CR
Timepoint [2] 0 0
Up to 5 years 2 months
Secondary outcome [3] 0 0
Recurrence-Free Survival (RFS)
Timepoint [3] 0 0
Up to 5 years 2 months
Secondary outcome [4] 0 0
Time to Progression (TTP)
Timepoint [4] 0 0
Up to 5 years 2 months
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
Up to 5 years 2 months
Secondary outcome [6] 0 0
Cancer Specific Survival (CSS)
Timepoint [6] 0 0
Up to 5 years 2 months
Secondary outcome [7] 0 0
Number of Participants with Adverse Events (AEs) by Grades According to Common Terminology Criteria for Adverse Events (CTCAE)
Timepoint [7] 0 0
Up to 5 years 2 months
Secondary outcome [8] 0 0
Number of Participants with Adverse Events (AEs)
Timepoint [8] 0 0
Up to 5 years 2 months
Secondary outcome [9] 0 0
Number of Participants with Change from Baseline in Laboratory Abnormalities
Timepoint [9] 0 0
Up to 5 years 2 months
Secondary outcome [10] 0 0
Number of Participants with Change from Baseline in Vital Signs Abnormalities
Timepoint [10] 0 0
Up to 5 years 2 months
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
Up to 5 years 2 months
Secondary outcome [12] 0 0
Time to Symptom Deterioration as Assessed by EORTC-QLQ-NMIBC 24 Scores
Timepoint [12] 0 0
Up to 5 years 2 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
18/09/2029
Actual
Sample size
Target
Accrual to date
Final
1135
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Austin Health - Heidelberg
Recruitment hospital [2] 0 0
Macquarie University Hospital - Macquarie University
Recruitment hospital [3] 0 0
Hollywood Private Hospital - Nedlands
Recruitment hospital [4] 0 0
Mater Hospital Brisbane - South Brisbane
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
2109 - Macquarie University
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment outside Australia
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Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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).
Trial website
https://clinicaltrials.gov/study/NCT05714202
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05714202