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NCT06503614 · ClinicalTrials.gov registry record · Phase 2
A Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer
A Phase 2 study of Non-muscle Invasive Bladder Cancer and Non-Muscle Invasive Bladder Urothelial Carcinoma, sponsored by John Sfakianos.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 3
- Study locations
NCT06503614: Recruiting Phase 2 study of Non-muscle Invasive Bladder Cancer and Non-Muscle Invasive Bladder Urothelial Carcinoma, sponsored by John Sfakianos.
NCT06503614 is a Phase 2 study of Non-muscle Invasive Bladder Cancer and Non-Muscle Invasive Bladder Urothelial Carcinoma that is actively recruiting participants, run by John Sfakianos. The registered enrollment target is 60 participants, below the 225-participant average among 30 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (73% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06503614, a Phase 2 study of Non-muscle Invasive Bladder Cancer and Non-Muscle Invasive Bladder Urothelial Carcinoma, is actively recruiting participants, sponsored by John Sfakianos.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
Complete response will be determined by bladder biopsy and urinary cytology for malignancy for subjects with a CIS component at 6 months CT/MRI urography will be used to rule out extravesical disease. (Cohort A)
Conditions Studied
Interventions
- DRUG Durvalumab
- DRUG Monalizumab
Study Locations (3)
Florida
- Moffitt Cancer Center - Tampa
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-02-24 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
What NCT06503614 shows while recruiting
NCT06503614 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 225-participant average among 30 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (73% lower).
The record links to 2 conditions, with Non-muscle Invasive Bladder Cancer appearing as the primary indexed condition, and to 2 interventions - of which Durvalumab is the first listed.
NCT06503614 reports a single indexed study location in Florida, New Jersey, New York.
Frequently Asked Questions
What is clinical trial NCT06503614 about?
NCT06503614 is a clinical study titled "A Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer". 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 no...
What is the current status of trial NCT06503614?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2025-02-24. Estimated completion is 2027-12.
What conditions does trial NCT06503614 study?
This clinical trial studies the following conditions: Non-muscle Invasive Bladder Cancer, Non-Muscle Invasive Bladder Urothelial Carcinoma.
What interventions are being tested in trial NCT06503614?
The interventions under investigation include: Durvalumab (DRUG), Monalizumab (DRUG).
Who is sponsoring clinical trial NCT06503614?
This trial is sponsored by John Sfakianos, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06503614 being conducted?
This trial has 3 study locations across Florida, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06503614's enrollment target sits among peer trials
60 19th of 30 higher than 12 of 30 other Non-muscle Invasive Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-muscle Invasive Bladder Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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