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NCT05775471 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab and Enfortumab Vedotin With Pembrolizumab Prior to and After Radical Nephroureterectomy for High-Risk Upper Tract Urothelial Cancer
A Phase 2 study of Renal Pelvis and Ureter Urothelial Carcinoma, sponsored by Jonsson Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT05775471: Recruiting Phase 2 study of Renal Pelvis and Ureter Urothelial Carcinoma, sponsored by Jonsson Comprehensive Cancer Center.
NCT05775471 is a Phase 2 study of Renal Pelvis and Ureter Urothelial Carcinoma that is actively recruiting participants, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05775471, a Phase 2 study of Renal Pelvis and Ureter Urothelial Carcinoma, is actively recruiting participants, sponsored by Jonsson Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II clinical trial tests how well pembrolizumab plus enfortumab vedotin prior to and after radical nephroureterectomy works in treating patients with high-risk upper tract urothelial cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Enfortumab vedotin (EV) is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of cancer cells. Enfortumab attaches to a protein called nectin-4 on cancer cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate. Radical nephroureterectomy (RNU) is the surgical removal of a kidney and its ureter. Giving pembrolizumab plus enfortumab vedotin before surgery may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed and giving pembrolizumab after surgery may kill any remaining cancer cells.
Primary Outcome
Will be assessed by the combination of partial response (PR) and complete response (CR). PR is defined as pathologic stage \<T2 disease. CR is defined as pT0 disease and assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Biopsy
- DRUG Enfortumab Vedotin
- PROCEDURE MR Urography
- PROCEDURE Nephroureterectomy
Study Locations (1)
California
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2024-06-26 |
| Est. Completion | 2028-12-01 |
| Phase | Phase 2 |
What NCT05775471 shows while recruiting
NCT05775471 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Renal Pelvis and Ureter Urothelial Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05775471 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05775471 about?
NCT05775471 is a clinical study titled "Pembrolizumab and Enfortumab Vedotin With Pembrolizumab Prior to and After Radical Nephroureterectomy for High-Risk Upper Tract Urothelial Cancer". This phase II clinical trial tests how well pembrolizumab plus enfortumab vedotin prior to and after radical nephroureterectomy works in treating patients with high-risk upper tract urothelial cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system ...
What is the current status of trial NCT05775471?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2024-06-26. Estimated completion is 2028-12-01.
What conditions does trial NCT05775471 study?
This clinical trial studies the following conditions: Renal Pelvis and Ureter Urothelial Carcinoma.
What interventions are being tested in trial NCT05775471?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Biopsy (PROCEDURE), Enfortumab Vedotin (DRUG), MR Urography (PROCEDURE), Nephroureterectomy (PROCEDURE).
Who is sponsoring clinical trial NCT05775471?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05775471 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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