A Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer (NCT06503614)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Moffitt Cancer Center — Tampa, Florida
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (4 Sites)
- Moffitt Cancer Center — Tampa, Florida
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey
- Icahn School of Medicine at Mount Sinai — New York, New York
- Weill Cornell Medical Center — New York, New York
📞 Contact the Study Coordinator
Phone: (212) 659-9375
Email: john.sfakianos@mountsinai.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Non-muscle Invasive Bladder Cancer
- A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer — Birmingham, Alabama
- Study of CG0070 After Transurethral Resection in Patients With IR NMIBC — Tampa, Florida
- A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer — Tucson, Arizona
- Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention — Dallas, Texas
- Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment — Basking Ridge, New Jersey
Explore by condition: All Non-muscle Invasive Bladder Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.