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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

August 11, 2023

Primary Completion Date

June 16, 2025

Study Completion Date

May 30, 2027

Conditions
Non-Muscle- Invasive Bladder Cancer
Interventions
BIOLOGICAL

Durvalumab

Participants will receive Durvalumab via intravenous infusion from Week 1 for 13 cycles every 4 weeks (q4w) for maximum 12 months.

BIOLOGICAL

BCG

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.

Trial Locations (19)

13210

Research Site, Syracuse

21076

Research Site, Hanover

21203

Research Site, Baltimore

29572

Research Site, Myrtle Beach

32209

Research Site, Jacksonville

33016

Research Site, Hialeah

37209

Research Site, Nashville

45212

Research Site, Cincinnati

46143

Research Site, Greenwood

48073

Research Site, Royal Oak

48084

Research Site, Troy

67226

Research Site, Wichita

72211

Research Site, Little Rock

78759

Research Site, Austin

80228

Research Site, Lakewood

85054

Research Site, Phoenix

92123

Research Site, San Diego

99202

Research Site, Spokane

19004-1017

Research Site, Bala-Cynwyd

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

lead

AstraZeneca

INDUSTRY