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Antibody-Drug Conjugate

Enfortumab Vedotin + Pembrolizumab for Bladder Cancer

Phase 2
Recruiting
Led By David Aggen, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Male/female participants who are at least 18 years of age with histologically confirmed diagnosis of muscle invasive bladder cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will test whether a combination of enfortumab vedotin and pembrolizumab is an effective treatment for people with urothelial carcinoma involving the lymph nodes who are going to have surgery to remove their cancer.

Who is the study for?
This trial is for adults with muscle invasive bladder cancer who are fit for surgery to remove their cancer. They must have no prior treatments for advanced urothelial carcinoma, be eligible for platinum-based chemotherapy, and have an ECOG performance status of 0-1 (which means they are fully active or restricted in physically strenuous activity but can do light work). Participants need functioning major organs and agree to use contraception.Check my eligibility
What is being tested?
The study tests if enfortumab vedotin combined with pembrolizumab before surgery can eliminate lymph node cancer and shrink tumors in patients with bladder cancer. It explores whether these drugs, which boost the immune system's ability to kill cancer cells, work better together than alone.See study design
What are the potential side effects?
Possible side effects include fatigue, skin reactions, neuropathy (nerve pain or numbness), diabetes or blood sugar problems, infusion-related reactions like fever or chills, liver issues, lung inflammation known as pneumonitis, and a weakened immune system leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can carry out all my daily activities without help.
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I am 18 or older with a confirmed diagnosis of muscle invasive bladder cancer.
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My cancer diagnosis was confirmed through a lymph node biopsy.
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My bladder cancer has been confirmed to be muscle invasive.
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I have not received any treatments for advanced bladder cancer.
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I am eligible for platinum-based chemotherapy.
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My kidney function, measured by eGFR, is at least 30.
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My cancer is at a stage where it has grown or spread but hasn't reached distant organs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pathologic complete response rate (pCR Rate)
Secondary outcome measures
Event free survival (EFS)

Side effects data

From 2023 Phase 2 trial • 219 Patients • NCT03219333
55%
Fatigue
52%
Decreased appetite
51%
Alopecia
46%
Nausea
43%
Peripheral sensory neuropathy
42%
Diarrhoea
39%
Dysgeusia
35%
Anaemia
32%
Weight decreased
28%
Constipation
28%
Dry skin
27%
Pruritus
25%
Oedema peripheral
24%
Dry eye
23%
Rash maculo-papular
21%
Abdominal pain
20%
Vomiting
19%
Urinary tract infection
18%
Cough
17%
Lacrimation increased
16%
Vision blurred
16%
Dizziness
16%
Back pain
16%
Dyspnoea
15%
Hyperglycaemia
15%
Aspartate aminotransferase increased
14%
Hyponatraemia
14%
Pyrexia
14%
Insomnia
13%
Hypokalaemia
13%
Lipase increased
12%
Fall
12%
Alanine aminotransferase increased
12%
Rash erythematous
11%
Neutropenia
11%
Pain in extremity
10%
Haematuria
10%
Amylase increased
10%
Dehydration
10%
Peripheral motor neuropathy
10%
Skin hyperpigmentation
9%
Dry mouth
8%
Blood creatinine increased
8%
Malaise
8%
Muscular weakness
8%
Arthralgia
8%
Stomatitis
8%
Myalgia
7%
Tachycardia
7%
Hyperuricaemia
7%
Punctate keratitis
7%
Gastrooesophageal reflux disease
7%
Hypotension
6%
Pneumonia
6%
Gait disturbance
6%
Asthenia
6%
Oral candidiasis
6%
Cellulitis
6%
Acute kidney injury
6%
Dysphagia
6%
Blood alkaline phosphatase increased
6%
Hypophosphataemia
6%
Musculoskeletal pain
6%
Blepharitis
6%
White blood cell count decreased
6%
Lymphocyte count decreased
6%
Rhinorrhoea
6%
Dysphonia
6%
Skin exfoliation
6%
Hypertension
5%
Abdominal pain upper
5%
Chills
5%
Rash macular
5%
Headache
4%
Febrile neutropenia
3%
Pollakiuria
3%
Sepsis
3%
Hypoalbuminaemia
3%
Anxiety
3%
Paraesthesia
3%
Abdominal distension
3%
Infusion related reaction
2%
Urinary tract obstruction
2%
Spinal cord compression
2%
Hypoxia
2%
Hypercalcaemia
2%
Acute respiratory failure
2%
Pneumonia aspiration
2%
Pulmonary embolism
2%
Rash vesicular
2%
Deep vein thrombosis
2%
Hyperkalaemia
2%
Transitional cell carcinoma metastatic
2%
Colitis
2%
Infusion site extravasation
1%
Confusional state
1%
Wound
1%
Delirium
1%
Infection
1%
Compression fracture
1%
Cancer pain
1%
Colon cancer
1%
Transitional cell carcinoma
1%
Interstitial lung disease
1%
Pleural effusion
1%
Stevens-Johnson syndrome
1%
Aortic stenosis
1%
Embolism
1%
Encephalopathy
1%
Palpitations
1%
Hypoglycaemia
1%
Hypomagnesaemia
1%
Drug eruption
1%
Cardiac disorder
1%
Enterocolitis
1%
Gastrointestinal haemorrhage
1%
Large intestinal obstruction
1%
Odynophagia
1%
Small intestinal obstruction
1%
Incarcerated hernia
1%
Bile duct stone
1%
Device related infection
1%
Urinary tract infection staphylococcal
1%
Neutrophil count decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Enfortumab Vedotin - Cohort 1
Enfortumab Vedotin - Cohort 2

Trial Design

1Treatment groups
Experimental Treatment
Group I: enfortumab vedotin in combination with pembrolizumabExperimental Treatment2 Interventions
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. Patients can proceed to surgery prior to completion of cycle 6 at the discretion of the investigator and urologist if toxicities prevent completion of 6 cycles of treatment. Enfortumab vedotin will be capped at a maximum dose of 125 mg for each infusion (for patients who weigh > 100 kg). Pembrolizumab will be administered on day 1 of each cycle, every 21 days, for 6 cycles. After completion of 3 cycles patients with have imaging assessment, and patients with progression of disease as measured by distant metastases will be removed from the study. At completion of cycle 6, patients will have repeat imaging assessment and proceed to cystectomy within 4-8 weeks. Following cystectomy, patients will resume pembrolizumab monotherapy on day 1 of each 21-day cycle for an additional 11 doses (Cycles 7-17), to complete 1 year of pembrolizumab therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enfortumab vedotin
2017
Completed Phase 2
~240
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,599 Total Patients Enrolled
Astellas Pharma US, Inc.Industry Sponsor
88 Previous Clinical Trials
12,810 Total Patients Enrolled
Seagen Inc.Industry Sponsor
207 Previous Clinical Trials
69,134 Total Patients Enrolled

Media Library

Enfortumab Vedotin (Antibody-Drug Conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT05239624 — Phase 2
Bladder Cancer Research Study Groups: enfortumab vedotin in combination with pembrolizumab
Bladder Cancer Clinical Trial 2023: Enfortumab Vedotin Highlights & Side Effects. Trial Name: NCT05239624 — Phase 2
Enfortumab Vedotin (Antibody-Drug Conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05239624 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings available in this clinical experiment?

"According to clinicaltrials.gov, this medical investigation is actively recruiting patients; the trial was posted on 2nd June 2022 and has had its parameters updated recently on 6th June 2022."

Answered by AI

To what extent are there establishments conducting this experiment in the city?

"13 clinical trial sites are taking part in this medical investigation, among them Memorial Sloan Kettering Nassau (Limited Protocol Activities) of Rockville Centre, Memorial Sloan Kettering -Nassau (Limited Protocol Activities) from Commack and Memorial Sloan Kettering Bergen (Limited Protocol Activities) situated in Montvale."

Answered by AI

What can be said about the safety of utilizing Enfortumab vedotin?

"Our team assigned a score of 2 to enfortumab vedotin's safety, since this is an early Phase 2 trial with some data backing its safety but none affirming its efficacy."

Answered by AI

What is the total enrollment for this research project?

"Affirmative. The information hosted on clinicaltrials.gov implies that this medical experiment, which was initiated on June 2nd 2022, is open for enrollment. A total of 23 patients are needed to be recruited between 13 distinct locations."

Answered by AI

Who else is applying?

How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Enfortumab Vedotin and Pembrolizumab in People With Bladder Cancer
2022. "Enfortumab Vedotin and Pembrolizumab in People With Bladder Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05239624.
All > Bladder Cancer
~9 spots leftby Jun 2025
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