Renal Retention in High Grade Upper Tract Urothelial Cancer

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT05656235
Phase
PHASE2
Status
Recruiting
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Conditions

  • Bladder Cancer
  • High Grade Urothelial Carcinoma
  • Urothelial Carcinoma Bladder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Enfortumab vedotin — DRUG
    Enfortumab vedotin 1.25mg/kg on Days 1 and 8 every 3 weeks for up to 35 weeks (each cycle = 21 days)
  • Pembrolizumab — DRUG
    Pembrolizumab 200mg on Day 1 every 3 weeks for up to 35 weeks (each cycle = 21 days)

Study Details

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.

Key Dates

Start date
Nov 25, 2024
Status verified
Jan 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Enfortumab vedotin with Pembrolizumab
    The study population will include male and female patients over the age of 18 with high grade UTUC (cN0/xM0) and is ineligible for or refuses definitive radical nephroureterectomy (RNU). Enfortumab vedotin will be administered on Days 1 and 8 at 1.25mg/kg of every 3-week cycle by intravenous (IV) infusion given over approximately 30 minutes. Pembrolizumab will be administered on Day 1 at 200mg of every 3-week cycle by IV infusion over approximately 30 minutes. Enfortumab vedotin and Pembrolizumab may be administered for up to total of 35 cycles (approximately 2 years).

Primary Outcome Measure

Event free survival (EFS) [ Time Frame: 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Johns Hopkins University: Sibley Memorial HospitalWashington D.C.District of Columbia20016
Carol Goldener, RN
[email protected]
202-660-5629
Jean Hoffman-Censits, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins University: Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21287
Debbie Schwartz, RN
[email protected]
410-502-4910
Jean Hoffman-Censtis, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Johns Hopkins University: Sibley Memorial Hospital· Washington D.C., DCJohns Hopkins University: Sidney Kimmel Comprehensive Cancer Center· Baltimore, MD

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