Actively Recruiting
Renal Retention in High Grade Upper Tract Urothelial Cancer
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2026-01-08
20
Participants Needed
2
Research Sites
235 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Renal Retention in High Grade Upper Tract Urothelial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults age 18 years or older
- Histologically confirmed high grade upper tract urothelial cancer diagnosed by biopsy or imaging plus urine cytology
- Patients who refuse radical nephroureterectomy surgery or are medically ineligible due to high risk of complications
- No prior systemic therapy for locally advanced or metastatic urothelial carcinoma except certain chemotherapy with >12 months recurrence
- May have radiographic evidence of single lymph node metastasis (N1 2 cm)
- ECOG Performance Status of 0 to 2
- Adequate blood counts and organ function as defined by laboratory values
- Female participants of childbearing potential must agree to pregnancy prevention and testing
- Male participants who can father children must agree to sperm donation restrictions and contraception
- Written informed consent provided
You will not qualify if you...
- Prior treatment with enfortumab vedotin or other MMAE-based antibody-drug conjugates
- Prior PD-(L)-1 inhibitor treatment for any cancer
- Prior treatment targeting other T-cell receptors like CTLA-4 or OX-40
- Recent chemotherapy, biologics, or investigational agents within 4 weeks before study treatment
- Uncontrolled diabetes with HbA1c 6% or associated symptoms
- Life expectancy less than 12 weeks
- Ongoing sensory or motor neuropathy grade 2 or higher
- Unresolved significant toxicity from previous treatments
- Receiving systemic antimicrobial treatment for active infection
- Active hepatitis B or C infection, or HIV infection
- Use of high dose steroids or immunosuppressive drugs
- Active second cancers except non-melanoma skin cancer and certain prostate cancers
- Recent radiotherapy or major surgery within 2 to 4 weeks
- Severe allergies to study drugs or their components
- Active keratitis or corneal ulcerations
- Recent autoimmune disease requiring systemic treatment
- History of certain lung diseases or active pneumonitis
- Prior allogeneic stem cell or solid organ transplant
- Recent live vaccine administration
- Active tuberculosis
- Other medical or psychiatric conditions impairing study compliance
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Johns Hopkins University: Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016
Actively Recruiting
2
Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
D
Debbie Schwartz, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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