Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03504163
The ClinicalTrials.gov registry entry for NCT03504163 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.
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 reports 7 study locations spanning 2 distinct geographic areas - top geographies include 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
Similar trials for Bladder Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Telehealth Intervention for Ostomy Self-Management
RECRUITING · Phase 2
-
Comprehensive Multimodal Prehabilitation Alone or With Neoadjuvant Therapy Before Major Cancer Surgery
RECRUITING · Phase 2
-
Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma
RECRUITING · Phase 2
-
Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)
RECRUITING · Phase 2
-
Atezolizumab Plus Etoposide and Platinum in Small Cell Bladder Cancer
RECRUITING · Phase 2
-
Intravesical Gemcitabine and Docetaxel for Low Grade Intermediate Risk Bladder Cancer
RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.