Actively Recruiting
Enfortumab Vedotin and Pembrolizumab in People With Bladder Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-13
23
Participants Needed
10
Research Sites
260 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
A
Astellas Pharma US, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Enfortumab Vedotin and Pembrolizumab in People With Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older with a confirmed diagnosis of muscle invasive bladder cancer or urothelial carcinoma involving the bladder, renal pelvis, ureter, or urethra
- Clinical stage T2-T4 with lymph node involvement N1-N3, M0 or cT1 with N2-N3, M0
- Histologically confirmed muscle invasive urothelial carcinoma from tumor samples or biopsy
- Evidence of urothelial carcinoma in lymph nodes by biopsy or imaging
- Medically suitable for radical cystectomy with treatment response as assessed by a urologic oncologist
- Both platinum eligible and ineligible patients can participate
- No prior treatments for muscle invasive or metastatic urothelial carcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Estimated glomerular filtration rate (eGFR) of 30 ml/min/1.73 m2 or higher
- Willing and able to provide written informed consent
- Agree to use contraception during treatment and for the specified time after treatment (males and females with specific conditions for females)
- Adequate organ function including blood counts, kidney, liver, and coagulation within required limits
You will not qualify if you...
- NYHA functional class III or IV heart disease
- Heart attack, severe angina, bypass surgery, heart failure, stroke, or transient ischemic attack within 6 months before treatment
- Ongoing serious heart rhythm problems except stable atrial fibrillation
- Pre-existing sensory neuropathy grade 2 or higher
- Major surgery within 28 days before treatment or planned major surgery besides cystectomy during study
- Psychiatric or substance abuse disorders interfering with participation
- Positive pregnancy test for women of childbearing potential
- Current enrollment in another therapeutic clinical trial
- Prior treatment with certain immunotherapy drugs or systemic anti-cancer therapies within 4 weeks
- Prior radiation therapy to bladder within 2 weeks before study treatment
- Recent live or live-attenuated vaccine within 30 days before treatment
- Recent intravesical BCG therapy within 4 weeks before treatment
- Diagnosis of immunodeficiency or use of immunosuppressive therapy within 7 days before treatment
- Poorly controlled HIV or AIDS-related illness
- Uncontrolled diabetes with specific criteria
- History of certain autoimmune diseases unless stable or controlled conditions
- History of serious lung disease or active pneumonitis
- Active hepatitis B or C infection
- Active tuberculosis or BCG infection
- Severe infections or signs of infection shortly before treatment
- Recent therapeutic antibiotics use for active infection
- Prior stem cell or organ transplant
- Unresolved side effects from prior cancer treatment except hair loss
- History of bone marrow disorders affecting treatment
- Significant liver disease
- Any other condition that increases risk or affects study results
- Active keratitis or corneal ulcers
- Certain skin conditions only if well controlled and limited in extent
- History of other malignancies within 5 years except certain low-risk cancers or those under surveillance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Baptist Alliance MCI
Miami, Florida, United States, 33143
Active, Not Recruiting
2
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
3
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
4
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
5
Memorial Sloan Kettering -Nassau
Commack, New York, United States, 11725
Actively Recruiting
6
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
8
Memorial Sloan Kettering Nassau
Rockville Centre, New York, United States, 11553
Actively Recruiting
9
Lehigh Valley Health Network (Data Collection Only)
Allentown, Pennsylvania, United States, 18103
Completed
10
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
Active, Not Recruiting
Research Team
D
David Aggen, MD, PhD
CONTACT
J
Jonathan Rosenberg, MD
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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