RecruitingPhase 2NCT05656235

Renal Retention in High Grade Upper Tract Urothelial Cancer

Renal Retention in High Grade Upper Tract Urothelial Cancer: A Phase II Trial of Enfortumab Vedotin and Pembrolizumab in Patients With Upper Tract Urothelial Cancer (UTUC) Who Are Not Candidates for, or Refuse, Nephroureterectomy

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

20 participants

Start Date

Nov 25, 2024

Study Type

INTERVENTIONAL

Conditions

Bladder Cancer Urothelial Carcinoma Bladder High Grade Urothelial Carcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a kidney-sparing approach for treating high-grade upper tract urothelial cancer (a cancer of the lining of the kidney or ureter) in patients who either cannot have surgery or refuse it. Instead of removing the kidney, doctors use targeted treatments to try to preserve kidney function. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of high-grade upper tract urothelial cancer - You either cannot safely have surgery (due to high surgical risk) or you are choosing not to have surgery - You have not received prior systemic (whole-body) therapy for this cancer **You may NOT be eligible if...** - You are able to have and have agreed to standard surgery (radical nephroureterectomy) - You have already received systemic chemotherapy for this cancer - You have other health conditions that prevent participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEnfortumab vedotin

Enfortumab vedotin 1.25mg/kg on Days 1 and 8 every 3 weeks for up to 35 weeks (each cycle = 21 days)

DRUGPembrolizumab

Pembrolizumab 200mg on Day 1 every 3 weeks for up to 35 weeks (each cycle = 21 days)

Locations(2)

Johns Hopkins University: Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

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NCT05656235

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