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Antibody-Drug Conjugate
Enfortumab Vedotin + Pembrolizumab for Bladder Cancer
Commack, NY
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
Must not have
Patients with specific prior treatments for bladder cancer
Women of childbearing potential with positive pregnancy test
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
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.
See full description
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 belowSelect...
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.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had treatments for bladder cancer before.
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I am of childbearing age and my pregnancy test is positive.
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I have had a major surgery recently.
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I have been treated with specific medications before.
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I have active keratitis or a history of corneal ulcers.
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I have severe heart disease that limits my daily activities.
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I have moderate to severe numbness or tingling in my hands or feet.
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I have a weak immune system or am on long-term steroids.
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I have not had any other cancers in the last 5 years.
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I have a specific skin condition.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pathologic complete response rate (pCR Rate)
Secondary study objectives
Event free survival (EFS)
Side effects data
From 2023 Phase 2 trial • 219 Patients • NCT0321933353%
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%
Vision blurred
16%
Dizziness
16%
Cough
15%
Aspartate aminotransferase increased
14%
Urinary tract infection
14%
Hyperglycaemia
14%
Insomnia
13%
Hypokalaemia
13%
Lipase increased
12%
Dyspnoea
12%
Pyrexia
12%
Rash erythematous
12%
Hyponatraemia
12%
Alanine aminotransferase increased
11%
Arthralgia
11%
Pain in extremity
11%
Fall
11%
Peripheral motor neuropathy
10%
Dehydration
10%
Skin hyperpigmentation
10%
Neutropenia
10%
Amylase increased
9%
Dry mouth
9%
Blood creatinine increased
8%
Stomatitis
8%
Muscular weakness
8%
Malaise
8%
Haematuria
7%
Punctate keratitis
7%
Hypotension
7%
Gastrooesophageal reflux disease
7%
Tachycardia
7%
Myalgia
7%
Lymphocyte count decreased
6%
Oral candidiasis
6%
Pneumonia
6%
Cellulitis
6%
Musculoskeletal pain
6%
Dysphagia
6%
Asthenia
6%
Skin exfoliation
6%
Blood alkaline phosphatase increased
6%
Dysphonia
6%
Blepharitis
6%
Hyperuricaemia
6%
Hypophosphataemia
6%
Rhinorrhoea
6%
Hypertension
6%
Gait disturbance
6%
White blood cell count decreased
5%
Rash macular
5%
Dysuria
5%
Abdominal pain upper
5%
Headache
4%
Chills
4%
Febrile neutropenia
3%
Acute kidney injury
3%
Hypoalbuminaemia
3%
Sepsis
3%
Infusion related reaction
3%
Abdominal distension
3%
Paraesthesia
3%
Anxiety
3%
Pollakiuria
2%
Hypercalcaemia
2%
Hyperkalaemia
2%
Hypoxia
2%
Transitional cell carcinoma metastatic
2%
Deep vein thrombosis
2%
Rash vesicular
2%
Pneumonia aspiration
2%
Pulmonary embolism
2%
Spinal cord compression
2%
Urinary tract obstruction
2%
Colitis
2%
Infusion site extravasation
2%
Acute respiratory failure
1%
Infection
1%
Neutrophil count decreased
1%
Confusional state
1%
Encephalopathy
1%
Hypoglycaemia
1%
Delirium
1%
Pleural effusion
1%
Palpitations
1%
Hypomagnesaemia
1%
Interstitial lung disease
1%
Embolism
1%
Transitional cell carcinoma
1%
Colon cancer
1%
Urinary tract infection staphylococcal
1%
Cancer pain
1%
Stevens-Johnson syndrome
1%
Device related infection
1%
Incarcerated hernia
1%
Compression fracture
1%
Wound
1%
Drug eruption
1%
Aortic stenosis
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 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
Pembrolizumab
2017
Completed Phase 3
~2630
Enfortumab vedotin
2017
Completed Phase 2
~240
Find a Location
Closest Location:Lehigh Valley Health Network (Data Collection Only)· Allentown, PA· 399 miles
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,995 Previous Clinical Trials
602,581 Total Patients Enrolled
Astellas Pharma US, Inc.Industry Sponsor
88 Previous Clinical Trials
12,814 Total Patients Enrolled
Seagen Inc.Industry Sponsor
211 Previous Clinical Trials
73,647 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,086 Previous Clinical Trials
5,223,884 Total Patients Enrolled
David Aggen, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can carry out all my daily activities without help.I am 18 or older with a confirmed diagnosis of muscle invasive bladder cancer.I have not received a live vaccine in the last 30 days.I am considered fit for major bladder surgery after responding to treatment.I have had treatments for bladder cancer before.My doctor agrees I am a good candidate for major bladder surgery after responding to treatment.I am of childbearing age and my pregnancy test is positive.My cancer diagnosis was confirmed through a lymph node biopsy.My bladder cancer has been confirmed to invade muscle, or it's in the prostate but without muscle invasion.My bladder cancer has been confirmed to be muscle invasive.I have not received any treatments for advanced bladder cancer.I have had a major surgery recently.My scans show a lymph node larger than 1.0 cm, suggesting cancer spread.I have been treated with specific medications before.I haven't had cancer treatment in the last 4 weeks.I have active keratitis or a history of corneal ulcers.I am eligible for platinum-based chemotherapy.I have severe heart disease that limits my daily activities.My kidney function, measured by eGFR, is at least 30.My organs are functioning well.I have had a recent heart problem or event.I have moderate to severe numbness or tingling in my hands or feet.My cancer is at a stage where it has grown or spread but hasn't reached distant organs.I have a weak immune system or am on long-term steroids.I have not had any other cancers in the last 5 years.I have a specific skin condition.My tests show signs of bladder cancer either through needle biopsy or imaging.I can provide tumor samples for the study, possibly less than 20 slides after discussing with the study lead.
Research Study Groups:
This trial has the following groups:- Group 1: enfortumab vedotin in combination with pembrolizumab
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.