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Trial Title: BCG in Combination With Durvalumab in Adult BCG-naïve, High-risk NMIBC Participants

NCT ID: NCT05943106

Condition: Non-Muscle- Invasive Bladder Cancer

Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Durvalumab

Conditions: Keywords:
Bacillus Calmette-Guerin (BCG)
BCG-naïve
immunotherapeutics
human mAb
Durvalumab
non-muscle-invasive bladder cancer (NMIBC)

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: Durvalumab
Description: Participants will receive Durvalumab via intravenous infusion from Week 1 for 13 cycles every 4 weeks (q4w) for maximum 12 months.
Arm group label: Durvalumab + BCG

Intervention type: Biological
Intervention name: BCG
Description: Participants will receive BCG via intravesical as induction weekly for 6 weeks starting at Week 1, Day 1 and subsequently for maintenance for 3 weekly doses up to 3, 6, 12, 18, and 24 months, at the physician's discretion as Standard of care.
Arm group label: Durvalumab + BCG

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.

Detailed description: This is an open-label, single-arm, multi-center, Phase IIIb US study exploring the combination of durvalumab and BCG (induction and maintenance) in participants with high-risk NMIBC. Each participant will have screening activities up to 4 weeks before initiation of study intervention, receive study intervention for up to 24 months, followed by 3 months safety follow-up. Participants will continue to be followed up for survival until 2 years from the date of treatment initiation of the last participant enrolled in this study (approximately 42 months after first participant enrolled).

Criteria for eligibility:
Criteria:
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, microcystic, squamous and adeno variants of UC representing > 50% of tumor tissue or other than urothelial tumors as assessed by pathology. - Evidence of lymphovascular invasion of bladder tumor, except if treatment with BCG is deemed to be the only clinically viable treatment. - Immediate cystectomy is indicated. - Known or documented absolute and/or relative contraindication of adjuvant intravesical BCG treatment. - Concurrent extravesical, non-muscle-invasive transitional cell carcinoma of the urothelium. - History of allogenic organ transplantation. Participants with any history of allogenic stem cell transplantation are also excluded. - Active or prior documented autoimmune or inflammatory disorders. - Participants with hypothyroidism stable on hormone replacement. - History of active primary immunodeficiency. - Active infection including hepatitis B (known positive HBV/HBsAg result), HCV, or HIV 1/2 (positive HIV) antibodies. - Current or prior use of immunosuppressive medication within 14 days before the first durvalumab dose. - Female participants who are pregnant or breastfeeding or male or female participants of reproductive potential who are not willing to employ highly effective birth control. - Any concurrent chemotherapy, study intervention, biologic or hormonal therapy for cancer treatment; uncontrolled intercurrent illness; - History of another primary malignancy except for Malignancy treated with curative intent and with no known active disease ≥ 2 years; Adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease; Adequately treated CIS without evidence of disease; Prostate cancer of stage ≤ T2cN0M0 without biochemical recurrence or progression that in the opinion of the Investigator does not require active intervention. - Previous or concurrent treatment with potent systemic immunostimulatory agents

Gender: All

Minimum age: 18 Years

Maximum age: 130 Years

Healthy volunteers: No

Locations: