Actively Recruiting
Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Cisplatin-eligible Upper Tract Urothelial Cancer
Led by University of Michigan Rogel Cancer Center · Updated on 2025-07-29
32
Participants Needed
1
Research Sites
136 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is a multi-site, single-arm, phase 2 trial of neoadjuvant combination of enfortumab vedotin and pembrolizumab in cisplatin-eligible patients with high-grade localized/locally advanced cT1-4 N0-1 M0 upper tract urothelial cancer who are deemed eligible for curative-intent surgery (radical nephroureterectomy or distal ureterectomy) followed by adjuvant pembrolizumab.
CONDITIONS
Official Title
Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Cisplatin-eligible Upper Tract Urothelial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of high-grade upper tract urothelial carcinoma confirmed by biopsy or cytology within 60 days before registration with stage cT1-4 N0-1 M0
- No small cell carcinoma component; predominant subtype must be urothelial carcinoma (≥50%)
- Candidate for curative surgery (nephroureterectomy or distal ureterectomy) as determined by a urologist
- Eligible for cisplatin chemotherapy with creatinine clearance ≥45 mL/min, no grade ≥2 peripheral neuropathy, and no severe heart failure
- Prior local endoscopic therapy allowed if completed at least 6 months before study treatment and toxicities resolved or improved to grade 1
- History or active non-invasive carcinoma or carcinoma in situ of bladder/urethra or upper tract allowed
- Prior intravesical chemotherapy or immunotherapy allowed
- Prior neoadjuvant or adjuvant chemotherapy or antibody-drug conjugate for bladder or contralateral upper tract cancer allowed if completed ≥1 year prior
- Age 18 years or older at registration
- ECOG performance status 0-1
- Hepatitis B or C patients eligible under specific antiviral therapy and viral load conditions
- Adequate organ and bone marrow function within 14 days prior to enrollment
- Women and men of reproductive potential must agree to use effective contraception during treatment and for 4 months after last dose
- Women of reproductive potential must have negative pregnancy test within 14 days before registration and not be breastfeeding
- No other medical conditions making participation unsafe in the opinion of the treating oncologist
- Ability to understand and willingness to sign informed consent; legally authorized representative or caregiver may consent if decision-making capacity is impaired
You will not qualify if you...
- Prior immune-mediated therapy such as anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2 antibodies, or therapeutic cancer vaccines
- Prior exposure to monomethyl auristatin E antibody-drug conjugates
- Use of immunosuppressive medication within 14 days before first pembrolizumab dose, except certain steroids and low-dose chronic immunosuppression
- Active or recent autoimmune or inflammatory disorders requiring immunosuppressive therapy within 2 years, except well-controlled thyroid disorders and some skin conditions
- Evidence of metastasis (N2-3 or M1) on baseline imaging
- History of invasive, node positive, or metastatic bladder cancer or invasive contralateral upper tract cancer within 2 years
- Enrollment in another interventional clinical trial at registration
- Active malignancy unless treated with no evidence for 1 year, with exceptions for some non-melanoma skin and in situ cancers
- Having only one kidney
- Pregnancy or lactation
- Severe hypersensitivity to study drugs or excipients
- Receipt of live vaccine within 30 days before first study drug dose
- Active infection requiring systemic therapy
- Conditions or lab abnormalities interfering with study participation or safety
- Known HIV infection
- Known active tuberculosis
- Psychiatric or substance abuse disorders interfering with trial cooperation
- History of allogenic tissue or solid organ transplant
- Ongoing significant toxicity from prior treatment (grade 2 or higher, except alopecia)
- Known active keratitis or corneal ulcerations
- Moderate or severe liver dysfunction not meeting study criteria
- Uncontrolled diabetes mellitus with hemoglobin A1c of 8 or greater
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
C
Cancer AnswerLine
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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