BCG in Combination With Durvalumab in Adult BCG-naïve, High-risk NMIBC Participants (NCT05943106) | Clinical Trial Compass
Active — Not RecruitingPhase 3
BCG in Combination With Durvalumab in Adult BCG-naïve, High-risk NMIBC Participants
United States100 participantsStarted 2023-08-11
Plain-language summary
The purpose of this study is to assess the safety, tolerability, and efficacy profile of durvalumab + BCG (induction and maintenance) combination therapy in adult United States participants with a histologically confirmed diagnosis of high-risk non-muscle-invasive bladder cancer (NMIBC), who have received no prior systemic therapy for NMIBC, and who are BCG-naïve.
Who can participate
Age range18 Years – 130 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* BCG-naïve (defined as participants not having received prior intravesical BCG or who previously received but stopped BCG more than 3 years before study entry).
* Local histological confirmation (based on cytology and/or pathology report) of high-risk transitional cell carcinoma of the urothelium of the urinary bladder confined to the mucosa or submucosa.
* Complete resection of all Ta/T1 papillary disease prior to enrollment, with the transurethral resection of bladder tumor (TURBT) removing high-risk NMIBC (non-muscle invasive bladder cancer) performed not more than 4 months before enrollment in the study.
* No prior radiotherapy for bladder cancer.
* A life expectancy of at least 12 weeks (90 days).
* Adequate organ and marrow function
* World Health Organization/Eastern Cooperative Oncology Group performance status of 0 or 1 at screening
* No prior exposure to immune-mediated therapy of cancer
* A candidate for BCG treatment.
* Local histological confirmation (based on cytology and/or pathology report) of high-risk transitional cell carcinoma of the urothelium of the urinary bladder confined to the mucosa or submucosa. A high-risk tumor is defined as one of the following: T1 tumor; High-grade/G3 tumor; CIS.
Exclusion Criteria:
* Evidence of muscle-invasive, locally advanced, metastatic, and/or extra-vesical bladder cancer (ie, T2, T3, T4, and / or Stage IV).
* Predominantly variant histology such as micropapillary, plasmacytoid, nested, sarcomatoid…
What they're measuring
1
Incidence of Grade 3 or 4 Possibly related adverse events (PRAEs)
Timeframe: From the date of the first dose of study treatment (Day 1) until 6 months after the initiation of study treatment