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Antibody-Drug Conjugate

Enfortumab Vedotin + Pembrolizumab for Bladder Cancer

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.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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 • 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%

Lacrimation increased

17%

Back pain

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%

Arthralgia

11%

Fall

11%

Pain in extremity

11%

Peripheral motor neuropathy

10%

Dehydration

10%

Neutropenia

10%

Skin hyperpigmentation

10%

Amylase increased

Dry mouth

Blood creatinine increased

Muscular weakness

Stomatitis

Malaise

Haematuria

Myalgia

Gastrooesophageal reflux disease

Punctate keratitis

Tachycardia

Hypotension

Lymphocyte count decreased

Blepharitis

Dysphagia

Rhinorrhoea

Pneumonia

Blood alkaline phosphatase increased

Cellulitis

Musculoskeletal pain

Dysphonia

Oral candidiasis

Hyperuricaemia

Hypophosphataemia

Asthenia

Gait disturbance

Hypertension

Skin exfoliation

White blood cell count decreased

Dysuria

Rash macular

Abdominal pain upper

Headache

Chills

Febrile neutropenia

Sepsis

Acute kidney injury

Infusion related reaction

Hypoalbuminaemia

Abdominal distension

Paraesthesia

Anxiety

Pollakiuria

Spinal cord compression

Hypoxia

Pneumonia aspiration

Deep vein thrombosis

Hyperkalaemia

Hypercalcaemia

Pulmonary embolism

Transitional cell carcinoma metastatic

Urinary tract obstruction

Rash vesicular

Colitis

Infusion site extravasation

Acute respiratory failure

Pleural effusion

Delirium

Urinary tract infection staphylococcal

Drug eruption

Confusional state

Palpitations

Incarcerated hernia

Device related infection

Neutrophil count decreased

Infection

Compression fracture

Aortic stenosis

Transitional cell carcinoma

Cancer pain

Interstitial lung disease

Embolism

Wound

Hypoglycaemia

Hypomagnesaemia

Colon cancer

Encephalopathy

Stevens-Johnson syndrome

Gastrointestinal haemorrhage

Enterocolitis

Cardiac disorder

Large intestinal obstruction

Odynophagia

Small intestinal obstruction

Bile duct stone

100%

80%

60%

40%

20%

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

~2810

Enfortumab vedotin

2017

Completed Phase 2

~240