Bladder Cancer Clinical Trial

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

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.

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Full 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).

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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

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

100

Study ID:

NCT05943106

Recruitment Status:

Recruiting

Sponsor:

AstraZeneca

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There are 24 Locations for this study

See Locations Near You

Research Site
Phoenix Arizona, 85054, United States
Research Site
Little Rock Arkansas, 72211, United States
Research Site
La Jolla California, 92037, United States
Research Site
San Diego California, 92123, United States
Research Site
Lakewood Colorado, 80228, United States
Research Site
Hialeah Florida, 33016, United States
Research Site
Jacksonville Florida, 32209, United States
Research Site
Greenwood Indiana, 46143, United States
Research Site
Jeffersonville Indiana, 47130, United States
Research Site
Wichita Kansas, 67226, United States
Research Site
Baltimore Maryland, 21203, United States
Research Site
Hanover Maryland, 21076, United States
Research Site
Royal Oak Michigan, 48073, United States
Research Site
Troy Michigan, 48084, United States
Research Site
Voorhees New Jersey, 08043, United States
Research Site
Syracuse New York, 13210, United States
Research Site
White Plains New York, 10601, United States
Research Site
Cincinnati Ohio, 45212, United States
Research Site
Columbus Ohio, 43230, United States
Research Site
Bala-Cynwyd Pennsylvania, 19004, United States
Research Site
Myrtle Beach South Carolina, 29572, United States
Research Site
Nashville Tennessee, 37209, United States
Research Site
Austin Texas, 78745, United States
Research Site
Spokane Washington, 99202, United States

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

100

Study ID:

NCT05943106

Recruitment Status:

Recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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