Study identifier:D419JC00002
ClinicalTrials.gov identifier:NCT05943106
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase IIIb Open-Label, Single-Arm, Multi-Center, US Study of Bacillus Calmette-Guerin (BCG) Administered in Combination with Durvalumab in Adult BCG-naïve, High-risk Non–Muscle- Invasive Bladder Cancer Participants (PATAPSCO)
Non–Muscle- Invasive Bladder Cancer
Phase 3
No
-
All
100
Interventional
18 Years - 130 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
PAREXEL
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Durvalumab + BCG Participants will receive Durvalumab for 13 cycles every 4 weeks (q4w) for a maximum 12 months. All participants will receive BCG (supplied by the site) intravesically, as induction weekly for 6 weeks. Patients will subsequently receive BCG for maintenance for 3 weekly doses at 3,6,12,18, and up to 24 months, at the physician's discretion. | - |