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Platinum-based Chemotherapy
Enfortumab Vedotin + Pembrolizumab vs. Chemotherapy for Bladder Cancer (EV-302 Trial)
Phase 3
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
Participants with prior definitive radiation therapy must have measurable disease per RECIST v1.1 that is outside the radiation field or has demonstrated unequivocal progression since completion of radiation therapy
Histologically documented, unresectable locally advanced or metastatic urothelial carcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights
EV-302 Trial Summary
This trial is testing if a combo of two drugs works better than other drugs to treat patients with urothelial cancer that has spread.
Who is the study for?
This trial is for adults with advanced urothelial cancer that has spread, who can handle cisplatin or carboplatin chemo and haven't had certain treatments before. They need to have a performance status score of 0-2, which means they're up and about more than half the day.Check my eligibility
What is being tested?
The study tests enfortumab vedotin plus pembrolizumab against standard chemotherapy alone in treating metastatic bladder cancer. It aims to see if the combination works better for patients whose disease has spread beyond their urinary system.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, fatigue, nausea, blood cell count changes leading to increased infection risk or bleeding problems, liver function issues, rash or skin problems.
EV-302 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer can be measured and has grown outside the area treated with radiation or after it.
Select...
My bladder cancer cannot be removed by surgery and has spread.
Select...
I am able to care for myself and perform daily activities.
EV-302 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of Overall survival (OS) (Arms A and B only, global population)
Duration of progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR) (Arms A and B only, global population)
Secondary outcome measures
Change from baseline in patient reported outcome assessment measured by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)
Change from baseline in patient reported outcome assessment measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L)
DCR per RECIST v1.1 by investigator assessment (Arms A and B only)
+13 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
EV-302 Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm C (Not Recruiting)Experimental Treatment4 Interventions
Enfortumab vedotin + pembrolizumab + Cisplatin or carboplatin
Group II: Arm AExperimental Treatment2 Interventions
Enfortumab vedotin + pembrolizumab
Group III: Arm BActive Control3 Interventions
Gemcitabine + cisplatin or carboplatin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Cisplatin
2013
Completed Phase 3
~1940
Enfortumab vedotin
2017
Completed Phase 2
~240
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Seagen Inc.Industry Sponsor
208 Previous Clinical Trials
73,238 Total Patients Enrolled
Astellas Pharma Global Development, Inc.Lead Sponsor
192 Previous Clinical Trials
120,096 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,890 Previous Clinical Trials
5,059,275 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer can be measured and has grown outside the area treated with radiation or after it.I have an active eye infection or corneal ulcer.My cancer has spread to my brain.I haven't had systemic therapy for advanced bladder cancer, except if it's been over a year since my last treatment.I have been treated with enfortumab vedotin or similar drugs before.I finished any cancer treatments at least 4 weeks before starting the study.I do not have active hepatitis B, C, or HIV.I had chemotherapy after bladder surgery and my cancer returned more than a year later.My blood counts and organ functions are within normal ranges.I have not had another invasive cancer in the last 3 years.I have not received a live vaccine in the last 30 days.I haven't had systemic therapy for advanced bladder cancer, with some exceptions.I still experience significant side effects from previous treatments.I am on medication for an active infection.My bladder cancer cannot be removed by surgery and has spread.I had a major surgery requiring a hospital stay over 24 hours within the last 4 weeks.I am able to care for myself and perform daily activities.I have been treated with drugs targeting immune system T-cells.My diabetes is not under control.I have not had radiotherapy in the last 2 weeks.I have had a stem cell or organ transplant from another person.My cancer returned more than a year after finishing initial chemotherapy.I have been treated with a PD-1 or PD-L1 inhibitor for cancer before.I have been treated for an autoimmune disease in the last 2 years.I've had a stroke, heart attack, or severe heart symptoms in the last 6 months.I can provide a sample of my cancer tissue for testing before joining the study.My doctor thinks I can be treated with cisplatin or carboplatin.I have a history of lung scarring or inflammation not caused by infections.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B
- Group 2: Arm C (Not Recruiting)
- Group 3: Arm A
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please provide the patient enrollment numbers for this experiment?
"In order to carry out this study, 990 patients that meet the inclusion criteria are needed. Seagen Inc. will be sponsoring the trial and conducting it out of different locations, such as Mount Sinai Medical Center in New york City and Memorial Sloan Kettering Cancer Center in Tampa, Florida."
Answered by AI
Are there long-term repercussions to Enfortumab vedotin?
"Enfortumab vedotin has passed multiple rounds of clinical trials with flying colours, so it receives a score of 3 for safety."
Answered by AI
What are the primary conditions that Enfortumab vedotin is prescribed for?
"Enfortumab vedotin is most commonly used to treat patients with lymphoma and non-hodgkin. However, it can also be used as a last-line treatment for patients with malignant melanoma of skin, recurrent cervical cancer, refractory, relapsed mediastinal large b-cell lymphoma."
Answered by AI
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