Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Upper Tract Urothelial Cancer

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT06356155
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Enfortumab vedotin — DRUG
    1.25 mg/kg IV
  • Pembrolizumab — DRUG
    200 mg IV

Study Details

This trial is a multi-site, single-arm, phase 2 trial of neoadjuvant combination of enfortumab vedotin and pembrolizumab in 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.

Key Dates

First listed
Apr 10, 2024
Start date
Jul 22, 2025
Status verified
Jul 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

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

Arms

  • Experimental: Combination Therapy
    Enfortumab vedotin 1.25 mg/kg IV on Days 1 and 8 and Pembrolizumab 200 mg IV on Day 1 (every 21 days for 4 cycles) Definitive surgery (radical nephroureterectomy RNU or distal ureterectomy per treating urologist) Pembrolizumab 200 mg IV on day 1 (every 21 days for up to 13 cycles) after surgery

Primary Outcome Measure

Efficacy of the combination of enfortumab vedotin and pembrolizumab as neoadjuvant therapy in patients based off pathological response [ Time Frame: up to 16 weeks post last neoadjuvant study drug (at time of surgery) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109
Irene Tsung, M.D.
[email protected]
734-936-4385
Irene Tsung, MD (PRINCIPAL_INVESTIGATOR)
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111
Elizabeth Plimack
[email protected]
215-214-3925

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