CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 23 target
Drug / intervention
Enfortumab vedotin +1 moredrug
Likely dose
Enfortumab vedotin 1.25 mg/kgfrom record
Key inclusion· 19
  • ✓Age at least 18 years at time of informed consent
  • ✓Histologically confirmed muscle invasive bladder cancer (transitional cell carcinoma) of bladder, renal pelvis, ureter, or urethra
  • ✓Clinical stage T2-T4, N1-N3, M0 OR cT1, N2-N3, M0
  • ✓Representative urothelial carcinoma FFPE tumor specimens (tumor blocks or ≥20 unstained slides)
Key exclusion· 34
  • ✕NYHA functional class III or IV heart disease
  • ✕Myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack within 6 months
  • ✕Ongoing cardiac dysrhythmias NCI CTCAE grade ≥2 (except stable atrial fibrillation)
  • ✕Pre-existing sensory grade ≥2 neuropathy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT05239624Phase 2RecruitingOn Track
Long Recruiting
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Enfortumab Vedotin in Combination With Pembrolizumab for Locally Advanced and/or Node Positive Urothelial Carcinoma Prior to Surgery (EV-ECLIPSE)

Memorial Sloan Kettering Cancer Center·interventional·Posted Feb 15, 2022·Updated Jun 4, 2026

In Brief

A Phase 2 clinical trial evaluating Enfortumab vedotin and Pembrolizumab for Urothelial Carcinoma. Currently recruiting, targeting 23 participants across 10 sites.

Detailed Summary

This study will test whether enfortumab vedotin combined with pembrolizumab is an effective treatment for people with bladder cancer (urothelial carcinoma) involving the lymph nodes who are going to have surgery to remove their cancer (cystectomy). The researchers will look at whether treatment with enfortumab vedotin and pembrolizumab before surgery can get rid of cancer within the lymph nodes. They will also try to find out if this combination of drugs is effective at shrinking participants' cancer before their surgery. The researchers think that a combination of enfortumab vedotin and pembrolizumab may help people with this disease because both drugs are designed to help the immune system attack and kill cancer cells. The researchers think the drugs may be more effective if given in combination rather than on their own.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrothelial Carcinoma
CountriesUnited States
CollaboratorsAstellas Pharma US, Inc., Seagen Inc., Merck Sharp & Dohme LLC

Timeline

Phase 2Recruiting
202220232024202520262027
First PostedFeb 15, 2022
Enrollment StartJun 2, 2022
Primary CompletionJun 1, 2027
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 4.4 years agoPrimary completion in 11 months

Interventions

Enfortumab vedotindrug

Enfortumab vedotin will be administered at 1.25 mg/kg on day 1 and day 8 of each 21-day cycle, for up to 6 cycles.

Pembrolizumabdrug

Pembrolizumab will be administered on day 1 of each cycle, every 21 days, for 6 cycles.