NCT05239624

Enfortumab Vedotin and Pembrolizumab in People With Bladder Cancer

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Enfortumab vedotin	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.
DRUG	Pembrolizumab	Pembrolizumab will be administered on day 1 of each cycle, every 21 days, for 6 cycles.

Timeline

• Start date: 2022-06-02
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2022-02-15
• Last updated: 2026-04-13

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study