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Antibody-Drug Conjugate

Enfortumab vedotin for Urologic Cancers (EV-201 Trial)

Phase 2
Waitlist Available
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cohort 1: median follow-up: 61.0 months (range 59.63, 62.36); cohort 2: median follow-up time: 45.8 months (range 44.91 to 48.95)
Awards & highlights
No Placebo-Only Group

Summary

This trial tests enfortumab vedotin, a new drug, on patients with advanced urinary system cancer who have limited treatment options. The drug targets and kills cancer cells. The study aims to see if the cancer shrinks and to monitor side effects. Enfortumab vedotin is approved for patients with advanced urothelial cancer who previously received specific treatments.

Eligible Conditions
  • Urologic Cancers
  • Ureter Cancer
  • Kidney Tumors
  • Bladder Cancer
  • Transitional Cell Carcinoma
  • Ureteral Tumors
  • Urethral Tumors
  • Urethral Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cohort 1: median follow-up: 61.0 months (range 59.63, 62.36); cohort 2: median follow-up time: 45.8 months (range 44.91 to 48.95)
This trial's timeline: 3 weeks for screening, Varies for treatment, and cohort 1: median follow-up: 61.0 months (range 59.63, 62.36); cohort 2: median follow-up time: 45.8 months (range 44.91 to 48.95) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)
Secondary study objectives
DCR16 Per Investigator Assessment
DOR Per Investigator Assessment
Disease Control Rate at 16 Weeks (DCR16) Per BICR
+20 more

Side effects data

From 2023 Phase 2 trial • 219 Patients • NCT03219333
53%
Fatigue
51%
Decreased appetite
51%
Alopecia
45%
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
19%
Vomiting
18%
Abdominal pain
17%
Back pain
17%
Lacrimation increased
16%
Dizziness
16%
Vision blurred
16%
Cough
15%
Aspartate aminotransferase increased
14%
Hyperglycaemia
14%
Urinary tract infection
14%
Insomnia
13%
Hypokalaemia
13%
Lipase increased
12%
Hyponatraemia
12%
Pyrexia
12%
Dyspnoea
12%
Rash erythematous
12%
Alanine aminotransferase increased
11%
Pain in extremity
11%
Arthralgia
11%
Fall
11%
Peripheral motor neuropathy
10%
Dehydration
10%
Neutropenia
10%
Skin hyperpigmentation
10%
Amylase increased
9%
Dry mouth
9%
Blood creatinine increased
8%
Stomatitis
8%
Muscular weakness
8%
Malaise
8%
Haematuria
7%
Myalgia
7%
Gastrooesophageal reflux disease
7%
Punctate keratitis
7%
Tachycardia
7%
Hypotension
7%
Lymphocyte count decreased
6%
Blepharitis
6%
Dysphagia
6%
Rhinorrhoea
6%
Pneumonia
6%
Blood alkaline phosphatase increased
6%
Cellulitis
6%
Musculoskeletal pain
6%
Dysphonia
6%
Oral candidiasis
6%
Hyperuricaemia
6%
Hypophosphataemia
6%
Asthenia
6%
Gait disturbance
6%
Hypertension
6%
Skin exfoliation
6%
White blood cell count decreased
5%
Dysuria
5%
Rash macular
5%
Abdominal pain upper
5%
Headache
4%
Chills
4%
Febrile neutropenia
3%
Sepsis
3%
Infusion related reaction
3%
Acute kidney injury
3%
Hypoalbuminaemia
3%
Abdominal distension
3%
Paraesthesia
3%
Anxiety
3%
Pollakiuria
2%
Spinal cord compression
2%
Hypoxia
2%
Pneumonia aspiration
2%
Deep vein thrombosis
2%
Hyperkalaemia
2%
Hypercalcaemia
2%
Pulmonary embolism
2%
Transitional cell carcinoma metastatic
2%
Urinary tract obstruction
2%
Rash vesicular
2%
Colitis
2%
Infusion site extravasation
2%
Acute respiratory failure
1%
Cancer pain
1%
Pleural effusion
1%
Encephalopathy
1%
Delirium
1%
Urinary tract infection staphylococcal
1%
Drug eruption
1%
Confusional state
1%
Incarcerated hernia
1%
Device related infection
1%
Neutrophil count decreased
1%
Infection
1%
Compression fracture
1%
Aortic stenosis
1%
Transitional cell carcinoma
1%
Interstitial lung disease
1%
Embolism
1%
Wound
1%
Hypoglycaemia
1%
Hypomagnesaemia
1%
Colon cancer
1%
Stevens-Johnson syndrome
1%
Palpitations
1%
Gastrointestinal haemorrhage
1%
Enterocolitis
1%
Cardiac disorder
1%
Large intestinal obstruction
1%
Odynophagia
1%
Small intestinal obstruction
1%
Bile duct stone
100%
80%
60%
40%
20%
0%
Study treatment Arm
Enfortumab Vedotin - Cohort 1
Enfortumab Vedotin - Cohort 2

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Enfortumab vedotinExperimental Treatment1 Intervention
Enfortumab vedotin on days 1, 8 and 15 every 28 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enfortumab vedotin
2017
Completed Phase 2
~240

Find a Location

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
200 Previous Clinical Trials
122,332 Total Patients Enrolled
Astellas Pharma IncLead Sponsor
695 Previous Clinical Trials
233,089 Total Patients Enrolled
Seagen Inc.Industry Sponsor
210 Previous Clinical Trials
74,211 Total Patients Enrolled

Media Library

Enfortumab Vedotin (Antibody-Drug Conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT03219333 — Phase 2
Urologic Cancers Research Study Groups: Enfortumab vedotin
Urologic Cancers Clinical Trial 2023: Enfortumab Vedotin Highlights & Side Effects. Trial Name: NCT03219333 — Phase 2
Enfortumab Vedotin (Antibody-Drug Conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03219333 — Phase 2
~27 spots leftby Nov 2025
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