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NCT03504163 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab (MK-3475) and Bacillus Calmette-Guérin (BCG) as First-Line Treatment for High-Risk T1 Non-Muscle-Invasive Bladder Cancer (NMIBC) and High-Grade Non-Muscle-Invasive Upper Tract Urothelial Carcinoma (NMI-UTUC)]
A Phase 2 study of Bladder Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
- 7
- Study locations
NCT03504163: Active Phase 2 study of Bladder Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
NCT03504163 is a Phase 2 study of Bladder Cancer that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 45 participants, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03504163, a Phase 2 study of Bladder Cancer, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this study is to find out the effectiveness of pembrolizumab in combination with BCG as a first line therapy for participants with high grade T1 bladder cancer who are at "high risk" for BCG alone to be ineffective and are seeking an alternative treatment option to radical cystectomy. There is biologic rationale for combining pembrolizumab and BCG as two distinct immunotherapies with possible additive or synergistic activity in urothelial cancer. The combination of pembrolizumab with BCG will also be evaluated in an exploratory cohort of patients with upper tract urothelial cancer.
Primary Outcome
The primary objective for the high-risk T1 bladder cohort is to estimate the proportion of patients who remain free from high-grade recurrence (by urine cytology, cystoscopy ± biopsy) at 6 months from the start of treatment with pembrolizumab (MK-3475) and BCG
Conditions Studied
Interventions
- DRUG Bacillus Calmette-Guérin (BCG)
- DRUG Pembrolizumab (MK-3475)
Study Locations (7)
New York
- Memorial Sloan Kettering Commack (All protocol activities) - Commack
- Memorial Sloan Kettering West Harrison (All Protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) - New York
- Memorial Sloan Kettering Nassau (All Protocol Activities) - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities) - Basking Ridge
- Memorial Sloan Kettering Monmouth (All Protocol Activities) - Middletown
- Memorial Sloan Kettering Bergen (All protocol activities) - Montvale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2018-06-27 |
| Est. Completion | 2026-04 |
| Phase | Phase 2 |
What the registry record for NCT03504163 still lists
NCT03504163 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Bladder Cancer appearing as the primary indexed condition, and to 2 interventions - of which Bacillus Calmette-Guérin (BCG) is the first listed.
NCT03504163 lists 7 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT03504163 about?
NCT03504163 is a clinical study titled "Pembrolizumab (MK-3475) and Bacillus Calmette-Guérin (BCG) as First-Line Treatment for High-Risk T1 Non-Muscle-Invasive Bladder Cancer (NMIBC) and High-Grade Non-Muscle-Invasive Upper Tract Urothelial Carcinoma (NMI-UTUC)]". The purpose of this study is to find out the effectiveness of pembrolizumab in combination with BCG as a first line therapy for participants with high grade T1 bladder cancer who are at "high risk" for BCG alone to be ineffective and are seeking an alternative treatment option to radical cystectomy....
What is the current status of trial NCT03504163?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2018-06-27. Estimated completion is 2026-04.
What conditions does trial NCT03504163 study?
This clinical trial studies the following conditions: Bladder Cancer.
What interventions are being tested in trial NCT03504163?
The interventions under investigation include: Bacillus Calmette-Guérin (BCG) (DRUG), Pembrolizumab (MK-3475) (DRUG).
Who is sponsoring clinical trial NCT03504163?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03504163 being conducted?
This trial has 7 study locations across 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 NCT03504163's enrollment target sits among peer trials
45 124th of 175 higher than 50 of 175 other Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
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