RecruitingPhase 2NCT05239624

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)


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

23 participants

Start Date

Jun 2, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial combines two drugs — enfortumab vedotin (an antibody-drug that targets cancer cells) and pembrolizumab (an immunotherapy) — given before bladder removal surgery in patients with muscle-invasive bladder cancer. The goal is to shrink the tumor before surgery and improve long-term outcomes. **You may be eligible if...** - You are 18 or older with muscle-invasive bladder cancer (or cancer of the ureter, kidney lining, or urethra) - Your cancer is confined locally or has spread to nearby lymph nodes but not to distant organs - You have not yet received treatment for muscle-invasive or metastatic disease - You are in generally good health (ECOG 0 or 1) **You may NOT be eligible if...** - You have severe heart failure or had a heart attack or stroke within 6 months - You have an active autoimmune disease or are on immunosuppressive therapy - You have active hepatitis B or C, or poorly controlled HIV - You have pre-existing nerve damage (grade 2 or higher neuropathy) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEnfortumab 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.

DRUGPembrolizumab

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


Locations(10)

Baptist Alliance MCI

Miami, Florida, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering -Nassau

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau

Rockville Centre, New York, United States

Lehigh Valley Health Network (Data Collection Only)

Allentown, Pennsylvania, United States

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05239624


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