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RECRUITING Phase 2

Renal Retention in High Grade Upper Tract Urothelial Cancer

NCT05656235 · View on ClinicalTrials.gov ↗

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.

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

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 311 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05656235 reports 2 study locations spanning 2 distinct geographic areas — top geographies include District of Columbia, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05656235?

The interventions under investigation include: Pembrolizumab (DRUG), Enfortumab vedotin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05656235?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 311 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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