RecruitingPhase 2NCT06503614

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


Sponsor

John Sfakianos

Enrollment

60 participants

Start Date

Feb 24, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests two immunotherapy drugs — durvalumab and monalizumab — for bladder cancer that has not spread into the muscle wall (non-muscle-invasive bladder cancer). It is designed for patients whose cancer has not responded to or has come back after BCG treatment, a standard bladder cancer therapy, and who cannot or prefer not to have their bladder removed. **You may be eligible if...** - You are 18 or older with high-grade bladder cancer confined to the inner lining (not the muscle) - Your cancer has not responded to or has returned after BCG therapy - You are unable or unwilling to have your bladder surgically removed - Your visible tumor was completely removed before joining the study - You have adequate kidney, liver, and blood function **You may NOT be eligible if...** - You have previously received PD-1 or PD-L1 immunotherapy drugs - You have active autoimmune disease requiring treatment (e.g., lupus, inflammatory bowel disease) - You have evidence of cancer that has spread beyond the bladder - You are pregnant or breastfeeding - You have active hepatitis B, active hepatitis C, or untreated HIV with detectable virus Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDurvalumab

Durvalumab 1500mg IV

DRUGMonalizumab

Monalizumab 1500mg IV


Locations(4)

Moffitt Cancer Center

Tampa, Florida, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Weill Cornell Medical Center

New York, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06503614


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