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NCT05656235 · ClinicalTrials.gov registry record · Phase 2

Renal Retention in High Grade Upper Tract Urothelial Cancer

A Phase 2 study of Bladder Cancer and Urothelial Carcinoma Bladder, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Recruiting
Registry status
Phase 2
Development phase
20
Enrollment target
2
Study locations

NCT05656235 is a Phase 2 study of Bladder Cancer and Urothelial Carcinoma Bladder that is actively recruiting participants, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 20 participants, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT05656235, a Phase 2 study of Bladder Cancer and Urothelial Carcinoma Bladder, is actively recruiting participants, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

RECRUITING
Registry status
Phase 2
Development phase
20 participants
Enrollment target
2
Study locations

Study Summary

This trial will evaluate the use of combination pembrolizumab and enfortumab vedotin for patients with high grade non-metastatic (cN0/NxMx, no measurable regional lymph nodes, no metastases) upper tract urothelial cancer (UTUC), preferring to forego standard of care radical nephroureterectomy (RNU) surgery. Currently these patients would not be suitable candidates for neoadjuvant trials, as the patients intention is to forego surgery. The patients are also not candidates for metastatic trials, as the patients have no measurable metastasis. The Investigators hypothesize the combination of pembrolizumab and enfortumab vedotin for patients with high grade cN0/NxMx UTUC deferring RNU will lead to event free survival outcomes similar to that achieved by RNU in a historic dataset.

Conditions Studied

Bladder Cancer Urothelial Carcinoma Bladder High Grade Urothelial Carcinoma

Interventions

  • DRUG Pembrolizumab
  • DRUG Enfortumab vedotin

Study Locations (2)

District of Columbia

  • Johns Hopkins University: Sibley Memorial Hospital - Washington D.C.

Maryland

  • Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center - Baltimore

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2024-11-25
Est. Completion 2029-06
Phase Phase 2

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

523 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05656235

The ClinicalTrials.gov registry entry for NCT05656235 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.

NCT05656235 reports 2 study locations spanning 2 distinct geographic areas - top geographies include District of Columbia, Maryland.

Frequently Asked Questions

What is clinical trial NCT05656235 about?

NCT05656235 is a clinical study titled "Renal Retention in High Grade Upper Tract Urothelial Cancer". This trial will evaluate the use of combination pembrolizumab and enfortumab vedotin for patients with high grade non-metastatic (cN0/NxMx, no measurable regional lymph nodes, no metastases) upper tract urothelial cancer (UTUC), preferring to forego standard of care radical nephroureterectomy (RNU) ...

What is the current status of trial NCT05656235?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2024-11-25. Estimated completion is 2029-06.

What conditions does trial NCT05656235 study?

This clinical trial studies the following conditions: Bladder Cancer, Urothelial Carcinoma Bladder, High Grade Urothelial Carcinoma.

What interventions are being tested in trial NCT05656235?

The interventions under investigation include: Pembrolizumab (DRUG), Enfortumab vedotin (DRUG).

Who is sponsoring clinical trial NCT05656235?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05656235 being conducted?

This trial has 2 study locations across District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.