Trials / Recruiting
RecruitingNCT06503614
A Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- John Sfakianos · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Durvalumab | Durvalumab 1500mg IV |
| DRUG | Monalizumab | Monalizumab 1500mg IV |
Timeline
- Start date
- 2025-02-24
- Primary completion
- 2027-12-22
- Completion
- 2032-12-22
- First posted
- 2024-07-16
- Last updated
- 2026-04-08
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06503614. Inclusion in this directory is not an endorsement.