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Study identifier: NCT06503614 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Non-muscle Invasive Bladder Cancer · Non-Muscle Invasive Bladder Urothelial Carcinoma  ·  Sponsor: John Sfakianos

PhasePhase 2
Planned participants60
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

John Sfakianos, MD  ·  212-659-9375  ·  john.sfakianos@mountsinai.org

Ahran Lee  ·  317-634-5842  ·  alee@hoosiercancer.org

Always discuss trial participation with your own doctor first.

Locations (4)

Moffitt Cancer CenterTampa, Florida, United StatesRecruiting
Rutgers Cancer Institute of New JerseyNew Brunswick, New Jersey, United StatesRecruiting
Icahn School of Medicine at Mount SinaiNew York, New York, United StatesRecruiting
Weill Cornell Medical CenterNew York, New York, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06503614