A Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer

ClinicalTrials.gov ID: NCT06503614

Public ClinicalTrials.gov record NCT06503614. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 2, 2026, 9:29 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT06503614
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: John Sfakianos; Other
Enrollment: 60 participants

Conditions and interventions

Conditions

Interventions

Durvalumab Drug
Monalizumab Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Feb 23, 2025
Primary completion: Dec 21, 2027
Completion: Dec 21, 2032
Last update posted: Apr 7, 2026

2025 – 2032

United States locations

U.S. sites: 4
U.S. states: 3
U.S. cities: 3

Facility	City	State	ZIP	Site status
Moffitt Cancer Center	Tampa	Florida	33612	Recruiting
Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey	08903	Recruiting
Icahn School of Medicine at Mount Sinai	New York	New York	10029	Recruiting
Weill Cornell Medical Center	New York	New York	10065	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06503614, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Apr 7, 2026 · Synced Sep 2, 2026

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The complete protocol, eligibility criteria, and contact information for NCT06503614 live on ClinicalTrials.gov.

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