What side effects are associated with this type of intervention?

Enfortumab Vedotin, an antibody-drug conjugate targeting Nectin-4, has been associated with several side effects in the treatment of bladder cancer. Common side effects include neuropathy, alopecia, rash, decreased appetite, and dysgeusia. Severe side effects are less common but can include serious skin reactions and hyperglycemia. Other treatments for bladder cancer, such as intravesical chemotherapy with mitomycin or gemcitabine, can cause chemical cystitis, rash, and myelosuppression, although these are generally less severe compared to systemic chemotherapy.

What prior FDA approvals exist?

Enfortumab Vedotin is an antibody-drug conjugate targeting Nectin-4, approved for the treatment of advanced urothelial carcinoma, a common type of bladder cancer, particularly in patients who have previously received platinum-based chemotherapy and anti-PD-1/PD-L1 therapy. Other FDA-approved treatments for bladder cancer include immune checkpoint inhibitors such as Pembrolizumab and Atezolizumab, which target PD-1 and PD-L1 respectively, and are used in similar patient populations. These therapies represent significant advancements in the treatment of bladder cancer by leveraging the body's immune system to target and destroy cancer cells.

What other types of research exist?

Promising novel alternatives to Enfortumab Vedotin for bladder cancer patients include immune checkpoint inhibitors such as Pembrolizumab and Nivolumab, which have shown efficacy in advanced urothelial carcinoma. Additionally, targeted therapies like Erdafitinib, an FGFR inhibitor, and novel antibody-drug conjugates like Sacituzumab Govitecan, targeting Trop-2, are also emerging as potential treatments.

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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

Must not have

Current or prior history of muscle-invasive urothelial carcinoma or metastatic disease

Participant has had any prior radiation to the bladder for urothelial cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial tests a new treatment for bladder cancer by delivering the drug directly into the bladder through a thin tube. The study will determine the best dose and evaluate its effectiveness and side effects.

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.

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.

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 below

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I can take care of myself and perform daily activities.

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I cannot or do not want to undergo major bladder surgery.

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My bladder cancer is not responding to BCG treatment.

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More than half of my cancer is urothelial carcinoma.

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My bladder cancer is confirmed and has not spread into the muscle.

Exclusion Criteria

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

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I have or had advanced bladder cancer.

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I have received radiation treatment for bladder cancer before.

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My cancer has caused swelling in my kidney due to urine blockage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Incidence of adverse events (AEs)

Incidence of dose limiting toxicities (DLTs)

Incidence of laboratory abnormalities

Secondary study objectives

Complete response (CR) rate

Cystectomy-free survival

Duration of CR

+8 more

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%

Pyrexia

12%

Dyspnoea

12%

Rash erythematous

12%

Hyponatraemia

12%

Alanine aminotransferase increased

11%

Fall

11%

Pain in extremity

11%

Arthralgia

11%

Peripheral motor neuropathy

10%

Neutropenia

10%

Skin hyperpigmentation

10%

Dehydration

10%

Amylase increased

Dry mouth

Blood creatinine increased

Stomatitis

Malaise

Muscular weakness

Haematuria

Punctate keratitis

Tachycardia

Hypotension

Gastrooesophageal reflux disease

Myalgia

Lymphocyte count decreased

Blepharitis

Rhinorrhoea

Dysphagia

Pneumonia

Cellulitis

Musculoskeletal pain

Oral candidiasis

Gait disturbance

Dysphonia

Hypophosphataemia

Hypertension

Asthenia

Blood alkaline phosphatase increased

Hyperuricaemia

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

Pulmonary embolism

Pneumonia aspiration

Spinal cord compression

Hypoxia

Transitional cell carcinoma metastatic

Deep vein thrombosis

Hyperkalaemia

Hypercalcaemia

Urinary tract obstruction

Rash vesicular

Colitis

Infusion site extravasation

Acute respiratory failure

Cancer pain

Device related infection

Interstitial lung disease

Delirium

Palpitations

Drug eruption

Incarcerated hernia

Urinary tract infection staphylococcal

Embolism

Neutrophil count decreased

Stevens-Johnson syndrome

Infection

Compression fracture

Aortic stenosis

Wound

Hypoglycaemia

Hypomagnesaemia

Colon cancer

Transitional cell carcinoma

Encephalopathy

Confusional state

Pleural effusion

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

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

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Bladder cancer treatments include a variety of mechanisms to target and destroy cancer cells. Antibody-drug conjugates (ADCs) like Enfortumab Vedotin target specific proteins on cancer cells, such as Nectin-4, to deliver cytotoxic agents directly to the tumor, minimizing damage to healthy cells. Immune checkpoint inhibitors, such as pembrolizumab and nivolumab, enhance the body's immune response against cancer cells by blocking proteins that inhibit immune activity. Traditional chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, including cancer cells, but can also affect normal cells. These treatments are crucial for bladder cancer patients as they offer targeted and effective options, potentially improving outcomes and reducing side effects compared to conventional therapies.

Oncofid-P-B: a novel treatment for BCG unresponsive carcinoma in situ (CIS) of the bladder: Results of a prospective European Multicentre study at 15 months from treatment start.[The role of immunotherapy in the modern treatment of urothelial carcinoma].