Clinical trialNCT06503614RecruitingPhase 2Interventional

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

SponsorJohn SfakianosEnrollment60Non-Muscle Invasive Bladder Urothelial CarcinomaNon-muscle Invasive Bladder Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

John Sfakianos, MD
Icahn School of Medicine at Mount Sinai
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

5 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of California San Francisco
San Francisco, California, United States
Vadim Koshkin, MD
Recruiting
Moffitt Cancer Center
Tampa, Florida, United States
Juskaran Chadha, DO
Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Saum Ghodoussipour, MD
Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, United States
John P Sfakianos, MD
Recruiting
Weill Cornell Medical Center
New York, New York, United States
Douglas Scherr, MD
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

DurvalumabMonalizumab

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 24 Feb 2025
Primary completion: 22 Dec 2027
Completion: 22 Dec 2032
Last update posted: 5 Oct 2026
Registered enrollment: 60
Registry id: NCT06503614

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.