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NCT05239624 · ClinicalTrials.gov registry record · Phase 2
Enfortumab Vedotin and Pembrolizumab in People With Bladder Cancer
A Phase 2 study of Urothelial Carcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
- 10
- Study locations
NCT05239624: Recruiting Phase 2 study of Urothelial Carcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
NCT05239624 is a Phase 2 study of Urothelial Carcinoma that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 23 participants, below the 239-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (90% lower). The trial reports 10 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05239624, a Phase 2 study of Urothelial Carcinoma, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
- 10
- Study locations
Study Summary
This study will test whether enfortumab vedotin combined with pembrolizumab is an effective treatment for people with bladder cancer (urothelial carcinoma) involving the lymph nodes who are going to have surgery to remove their cancer (cystectomy). The researchers will look at whether treatment with enfortumab vedotin and pembrolizumab before surgery can get rid of cancer within the lymph nodes. They will also try to find out if this combination of drugs is effective at shrinking participants' cancer before their surgery. The researchers think that a combination of enfortumab vedotin and pembrolizumab may help people with this disease because both drugs are designed to help the immune system attack and kill cancer cells. The researchers think the drugs may be more effective if given in combination rather than on their own.
Primary Outcome
Defined as lack of muscle invasive carcinoma (\<pT2) and the absence of lymph node metastasis (N0) in the final cystectomy specimen. Pathologic complete response to perioperative treatment is defined as the absence of carcinoma (pT0) and the absence of lymph node metastases (N0). Pathologists will assess surgical specimens systematically using criteria agreed upon for all conventional neoadjuvant treatment based on the AJCC TNM staging system.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Enfortumab vedotin
Study Locations (10)
New York
- Memorial Sloan Kettering -Nassau - Commack
- Memorial Sloan Kettering Westchester - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau - Rockville Centre
New Jersey
- Memorial Sloan Kettering Basking Ridge - Basking Ridge
- Memorial Sloan Kettering Monmouth - Middletown
- Memorial Sloan Kettering Bergen - Montvale
Florida
- Baptist Alliance MCI - Miami
Pennsylvania
- Lehigh Valley Health Network (Data Collection Only) - Allentown
Texas
- University of Texas Southwestern Medical Center at Dallas - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2022-06-02 |
| Est. Completion | 2027-06 |
| Phase | Phase 2 |
What NCT05239624 shows while recruiting
NCT05239624 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 239-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Urothelial Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT05239624 lists 10 locations in 5 states (New York, New Jersey, Florida).
Frequently Asked Questions
What is clinical trial NCT05239624 about?
NCT05239624 is a clinical study titled "Enfortumab Vedotin and Pembrolizumab in People With Bladder Cancer". This study will test whether enfortumab vedotin combined with pembrolizumab is an effective treatment for people with bladder cancer (urothelial carcinoma) involving the lymph nodes who are going to have surgery to remove their cancer (cystectomy). The researchers will look at whether treatment with...
What is the current status of trial NCT05239624?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2022-06-02. Estimated completion is 2027-06.
What conditions does trial NCT05239624 study?
This clinical trial studies the following conditions: Urothelial Carcinoma.
What interventions are being tested in trial NCT05239624?
The interventions under investigation include: Pembrolizumab (DRUG), Enfortumab vedotin (DRUG).
Who is sponsoring clinical trial NCT05239624?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05239624 being conducted?
This trial has 10 study locations across Florida, New Jersey, New York, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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.
Where NCT05239624's enrollment target sits among peer trials
23 69th of 85 higher than 16 of 85 other Urothelial Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urothelial Carcinoma 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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