clinical trial · NCT06503614
A Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer
John Sfakianos·phase2·recruiting·n = 60
Non-muscle Invasive Bladder CancerNon-Muscle Invasive Bladder Urothelial CarcinomaDurvalumabMonalizumab
brief summary
This is a phase 2 open-label two cohort study of durvalumab plus monalizumab in patients with BCG-unresponsive or BCG-exposed CIS NMIBC. Arm A will enroll 43 participants who have cancer in situ (CIS) with or without high grade papillary urothelial cancer. Arm B will enroll 17 participants who do not have cancer in situ (CIS) but do have high grade papillary urothelial cancer. Eligible patients will be enrolled to receive up to 13 cycles of monthly combination of monalizumab and durvalumab. Both monalizumab and durvalumab will be administered intravenously (IV) every 28 days.
started
Feb 24, 2025
primary completion
Dec 22, 2027
completion
Dec 22, 2032
last updated
Oct 5, 2026
official title
ENHANCE (Elevated NKG2A and HLA-E Amplify NK/CD8 Checkpoint Engagers): A Phase 2 Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol