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Antibody-drug conjugate
Intravesical Enfortumab Vedotin for Bladder Cancer
Phase 1
Recruiting
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
Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2
Participant must be ineligible for or refusing a radical cystectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will test a drug, given through a catheter, for side effects and efficacy in treating non-muscle invasive bladder cancer.
Who is the study for?
This trial is for people with a type of bladder cancer called NMIBC who have had all visible tumors removed recently, can't or won't get their bladder taken out (radical cystectomy), and whose cancer isn't responding to BCG treatment. They should be able to perform daily activities with little help (ECOG score 0-2). People can't join if they've had radiation for bladder cancer, kidney issues due to the tumor, other recent cancer treatments, muscle-invasive or spread-out urothelial carcinoma.Check my eligibility
What is being tested?
The study tests enfortumab vedotin delivered directly into the bladder through a catheter in patients with NMIBC. It aims to find out how well this drug works and what side effects it may cause when used as a local treatment for this specific type of bladder cancer.See study design
What are the potential side effects?
While not specified here, common side effects from drugs like enfortumab vedotin could include irritation where the catheter enters the body, urinary symptoms such as pain or urgency, possible allergic reactions to the medication itself, and general drug-related side effects like nausea or fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and perform daily activities.
Select...
I cannot or do not want to undergo major bladder surgery.
Select...
My bladder cancer is not responding to BCG treatment.
Select...
More than half of my cancer is urothelial carcinoma.
Select...
My bladder cancer is confirmed and has not spread into the muscle.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events (AEs)
Incidence of dose limiting toxicities (DLTs)
Incidence of laboratory abnormalities
Secondary outcome measures
Complete response (CR) rate
Cystectomy-free survival
Duration of CR
+8 moreSide effects data
From 2023 Phase 2 trial • 219 Patients • NCT0321933355%
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%
Spinal cord compression
2%
Hypoxia
2%
Urinary tract obstruction
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
2Treatment groups
Experimental Treatment
Group I: Enfortumab vedotin: Dose expansion cohortExperimental Treatment1 Intervention
During the induction phase, participants will receive enfortumab vedotin once a week for 6 weeks. During the maintenance phase, participants will receive enfortumab vedotin once a month for 9 doses.
Group II: Enfortumab vedotin: Dose escalation cohortExperimental Treatment1 Intervention
During the induction phase, participants will receive enfortumab vedotin once a week for 6 weeks. During the maintenance phase, participants will receive enfortumab vedotin once a month for 9 doses.
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
121,028 Total Patients Enrolled
Seagen Inc.Industry Sponsor
208 Previous Clinical Trials
74,170 Total Patients Enrolled
Sujata Narayanan, MDStudy DirectorSeagen Inc.
1 Previous Clinical Trials
348 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have upper tract urothelial cancer, confirmed by a recent scan.My cancer has caused swelling in my kidney due to urine blockage.More than half of my cancer is urothelial carcinoma.I have or had advanced bladder cancer.My scans within the last 3 months show cancer has spread to my lymph nodes or other areas.I cannot or do not want to undergo major bladder surgery.I can take care of myself and perform daily activities.My bladder cancer is not responding to BCG treatment.I have received radiation treatment for bladder cancer before.All visible bladder tumors were fully removed within the last 60 days.I have had bladder cancer in the tube carrying urine within the last 6 months.My bladder cancer is confirmed and has not spread into the muscle.I have recently had cancer treatment with drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Enfortumab vedotin: Dose escalation cohort
- Group 2: Enfortumab vedotin: Dose expansion cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Bladder Cancer Patient Testimony for trial: Trial Name: NCT05014139 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an ongoing recruitment process for this clinical experiment?
"The information on clinicaltrials.gov confirms that this investigation is in the midst of recruiting subjects. It was initially listed on December 7th 2021 and revised most recently on November 1st 2022."
Answered by AI
In what scenarios is Enfortumab vedotin utilized most often?
"Enfortumab vedotin can be utilized in therapeutic operations, to combat metastatic urothelial cancer, and as an immunotherapeutic drug."
Answered by AI
How many facilities are administering this research?
"This trial is being hosted at 8 different medical centres, such as Laura & Isaac Perlmutter Cancer Center at NYU Langone Health in New york, University of Texas Southwestern Medical Center in Dallas, and Site CA11001 in Toronto. A few other locations are also available for participants."
Answered by AI
Are there any precedential experiments conducted with Enfortumab vedotin?
"The first clinical trial of enfortumab vedotin began in 2014 at US00019. Since then, 2 trials have concluded successfully and there are currently 18 ongoing studies recruiting patients, many located in the bustling city of New york."
Answered by AI
What are the main goals of this research endeavor?
"The primary goal of this trial, which will be assessed over a roughly 1 year timeline, is to study the rate of dose-limiting toxicities. Secondary objectives include examining the trough concentration and area under the curve for enfortumab vedotin as well as investigating any antitherapeutic antibodies towards it."
Answered by AI
Is this investigation pioneering in its approach?
"Presently, there are 18 Enfortumab vedotin clinical trials taking place worldwide in 377 cities and 44 countries. Seagen Inc. initiated the first study of this drug back in 2014 with 213 participants. In the years since then, two further investigations have finalised their Phase 1 stages."
Answered by AI
How many participants are included in this investigation?
"Seagen Inc., the sponsor of this trial, requires 58 participants who meet the inclusion criteria in order to run it. The study will be conducted at Laura & Isaac Perlmutter Cancer Center at NYU Langone Health and University of Texas Southwestern Medical Center, among other locations."
Answered by AI
Has Enfortumab vedotin been granted regulatory clearance to be marketed?
"Due to its Phase 1 status, the safety of enfortumab vedotin was estimated at a score of 1 as only minimal data exists regarding efficacy and safety."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
What site did they apply to?
Johns Hopkins Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
What questions have other patients asked about this trial?
1. Will I be taking a medication or will it be intravesicular?
PatientReceived no prior treatments
Why did patients apply to this trial?
I have had 3 6 week treatments 1st was BCG, second was Gemcitabine and Taxotere as was the 3rd which finished in April. Now they do not want to treat me any longer here in Ohio.
PatientReceived no prior treatments
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