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

Running, not enrolling · Phase 3

Conditions studied: Non-Muscle- Invasive Bladder Cancer

In brief

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.

Key facts

Study ID

NCT05943106

Run by

AstraZeneca

People needed

100

Starts

2023-08-11

Expected to finish

2027-03-31

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Research Site — Phoenix, Arizona, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — San Diego, California, United States
• Research Site — Lakewood, Colorado, United States
• Research Site — Hialeah, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Greenwood, Indiana, United States
• Research Site — Wichita, Kansas, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Hanover, Maryland, United States
• Research Site — Royal Oak, Michigan, United States
• Research Site — Troy, Michigan, United States
• Research Site — Syracuse, New York, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Bala-Cynwyd, Pennsylvania, United States
• Research Site — Myrtle Beach, South Carolina, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Austin, Texas, United States
• Research Site — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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