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) 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 pembr

Trial Details

NCT ID
NCT05656235
Phase
PHASE2
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Status
RECRUITING
Cancer Type
Urothelial Carcinoma Bladder Cancer
Interventions
  • Enfortumab vedotin
  • Pembrolizumab
Locations (sample)
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637
  • Baltimore, Maryland, United States|39.29038,-76.61219

Key Eligibility Criteria

  • Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of histolo…
  • Patients must refuse definitive radical nephroureterectomy (RNU), or be medically ineligible for surgery. To be medically ineligible, patients must…
  • Subjects must not have received prior systemic therapy for locally advanced or metastatic urothelial carcinoma (in other locations such as the blad…
  • Subjects who received neoadjuvant chemotherapy with recurrence \>12 months from completion of therapy are permitted

For full eligibility, visit ClinicalTrials.gov.

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