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Antibody-Drug Conjugate

Enfortumab vedotin for Bladder Cancer (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
Metastatic disease or locally advanced disease that is not resectable
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 16. data cut-off date 01 mar 2019 for cohort 1 and 08 sept 2020 for cohort 2.
Awards & highlights

EV-201 Trial Summary

This trial will test the experimental drug enfortumab vedotin on patients with urothelial cancer who have been previously treated with an immune checkpoint inhibitor. The study will look at if the cancer shrinks with treatment and also the side effects of the drug.

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

EV-201 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your cancer has spread to other parts of your body or is in an advanced stage that cannot be surgically removed.

EV-201 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to data cut-off date of 01 mar 2019 for cohort 1 and 08 sept 2020 for cohort 2 (cohort 1 median follow-up time: 10.15 months [range 0.49, 16.46]. cohort 2 median follow up time: 13.4 months [range 0.33 to 29.27]).
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to data cut-off date of 01 mar 2019 for cohort 1 and 08 sept 2020 for cohort 2 (cohort 1 median follow-up time: 10.15 months [range 0.49, 16.46]. cohort 2 median follow up time: 13.4 months [range 0.33 to 29.27]). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)
Secondary outcome measures
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
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%
Sepsis
3%
Pollakiuria
3%
Hypoalbuminaemia
3%
Anxiety
3%
Paraesthesia
3%
Abdominal distension
3%
Infusion related reaction
2%
Urinary tract obstruction
2%
Hypoxia
2%
Hypercalcaemia
2%
Spinal cord compression
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%
Delirium
1%
Infection
1%
Wound
1%
Confusional state
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

EV-201 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
192 Previous Clinical Trials
120,808 Total Patients Enrolled
Astellas Pharma IncLead Sponsor
689 Previous Clinical Trials
219,820 Total Patients Enrolled
Seagen Inc.Industry Sponsor
206 Previous Clinical Trials
69,120 Total Patients Enrolled

Media Library

Enfortumab Vedotin (Antibody-Drug Conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT03219333 — Phase 2
Bladder Cancer Research Study Groups: Enfortumab vedotin
Bladder Cancer 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

Frequently Asked Questions

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

How many individuals have opted to take part in this experiment?

"At present, no further participants are being sought for this medical trial. Initially posted on October 8th 2017 and last updated June 13th 2022, the study is now closed to new patients. If one desires to explore alternative trials in urologic neoplasms there are 2,825 studies available while 18 clinical trials have opened their doors for Enfortumab vedotin enrolment."

Answered by AI

Is Enfortumab vedotin a safe and reliable treatment option for patients?

"Based on our internal assessment, enfortumab vedotin was given a rating of 2 because this is currently at the Phase 2 stage and there are limited efficacy data available."

Answered by AI

Is this experimental research novel in terms of its approach?

"Seagen Inc. initiated the inaugural trial for Enfortumab vedotin in 2014, featuring a cohort of 213 participants. This Phase 1 clinical trial was successful enough to gain approval and since then 18 separate medical studies have been launched in 377 cities from 44 nations."

Answered by AI

How many healthcare facilities are providing this clinical exploration within the state?

"This clinical trial is currently operational at 69 distinct sites, including Davis, Scottsdale and Tualatin. For the sake of convenience, it is best to enlist in a location near you so that travel demands are kept minimal."

Answered by AI

To what type of ailments is enfortumab vedotin commonly prescribed?

"Enfortumab vedotin can be utilized for therapeutic procedures, attacking metastatic urothelial cancer and aiding in pharmacotherapy."

Answered by AI

Has Enfortumab vedotin been evaluated in any other research initiatives?

"In 2014, US00019 was the first site to research enfortumab vedotin. Currently, two studies have already been completed while 18 are in progress with a significant number of those trials being conducted from Davis, Arizona."

Answered by AI

Is recruitment for this trial still open?

"According to the data on clinicaltrials.gov, this medical study has ceased its search for participants as of June 13th 2022. Despite that, there are still 2843 other trials in need of volunteers at present time."

Answered by AI
Recent research and studies
~30 spots leftby Mar 2025