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Antibody-Drug Conjugate

Enfortumab Vedotin for Prostate Cancer (ENCORE Trial)

Phase 2
Recruiting
Led By Umang Swami, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of metastatic or locally advanced, inoperable disease that cannot be treated with definitive intent
Castrate levels of testosterone as defined as < 50 ng/dL (1.73 nmol/L).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

ENCORE Trial Summary

This trial is testing a new cancer drug, enfortumab, alone and in combination with other cancer drugs. The trial will start with testing enfortumab by itself (monotherapy), and additional groups (cohorts) may be added later as new drug combinations are found.

Who is the study for?
Men over 18 with advanced prostate cancer that's resistant to castration and has worsened after hormone therapy. They must have had prior chemotherapy, maintain low testosterone levels, and have good organ function. Participants need to agree to effective contraception and not have HIV or hepatitis with detectable viral loads.Check my eligibility
What is being tested?
The trial is testing Enfortumab Vedotin alone or with other anti-cancer drugs in men whose prostate cancer has spread and doesn't respond to hormone treatment anymore. It's an open-label phase II study where everyone knows what treatment they're getting.See study design
What are the potential side effects?
Enfortumab Vedotin may cause side effects like fatigue, rash, decreased appetite, neuropathy (nerve pain), blood sugar changes, infusion-related reactions, as well as liver and kidney issues.

ENCORE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer has spread and cannot be removed by surgery.
Select...
My testosterone levels are very low, below 50 ng/dL.
Select...
I can take care of myself and perform daily activities.
Select...
My prostate cancer is confirmed without being a small cell type.
Select...
I am a man aged 18 or older.
Select...
I have been treated with a newer hormone therapy for my cancer.
Select...
My blood, liver, and kidney functions meet the required levels for the study.
Select...
I stopped all cancer treatments (except hormone therapy and bone treatments) 28 days ago.
Select...
My condition worsened after hormone therapy.

ENCORE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion subjects achieving one of the following: Objective response by RECIST1.1, Confirmed conversion of circulating tumor cell count (CTC) to <5/7.5 mL blood, PSA decline ≥ 50% from baseline, or Stable disease ≥ 6 months per PCWG3 mod.RECIST 1.1

Side effects data

From 2023 Phase 2 trial • 219 Patients • NCT03219333
55%
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

ENCORE Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment: all patientsExperimental Treatment1 Intervention
Enfortumab will be administered in monotherapy on days 1, 8, and 15 as part of a 28-day cycle at 1.25 mg/kg up to 125 mg.
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 IncIndustry Sponsor
691 Previous Clinical Trials
232,181 Total Patients Enrolled
36 Trials studying Prostate Cancer
8,643 Patients Enrolled for Prostate Cancer
University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,655 Total Patients Enrolled
8 Trials studying Prostate Cancer
5,349 Patients Enrolled for Prostate Cancer
Umang Swami, MDPrincipal InvestigatorHuntsman Cancer Institute
1 Previous Clinical Trials
33 Total Patients Enrolled

Media Library

Enfortumab Vedotin (Antibody-Drug Conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT04754191 — Phase 2
Prostate Cancer Research Study Groups: Treatment: all patients
Enfortumab Vedotin (Antibody-Drug Conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04754191 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Enfortumab vedotin received regulatory permission to be used?

"In the opinion of our experts at Power, enfortumab vedotin is estimated to be relatively safe based on Phase 2 clinical data. There isn't yet any evidence that it's efficacy for this indication."

Answered by AI

What is the upper limit for participants in this scientific inquiry?

"Indeed, the clinicaltrials.gov database shows that this medical trial is currently recruiting patients since its posting on February 3rd 2022 and last update same date. As of now, 34 individuals are being admitted from a single centre."

Answered by AI

For which medical conditions is Enfortumab vedotin typically prescribed?

"Enfortumab vedotin is useful for treating metastatic urothelial cancer with a combination of pharmacotherapy and therapeutic procedures."

Answered by AI

Is enrollment for this experiment open at present?

"Indeed, the records on clinicaltrials.gov confirm that this scientific trial, originally published on February 3rd 2022, is actively recruiting individuals to take part in it. In total 34 participants must be sourced from a single medical centre."

Answered by AI

Is Enfortumab vedotin being explored in any other research studies?

"Currently, 18 studies are in progress regarding Enfortumab vedotin. 6 of the trials have advanced to Phase 3 and 1354 different healthcare sites across the world are running these clinical tests. The epicentre of research for this treatment is located in Pergamino, Arizona."

Answered by AI

Is this experimental research a pioneering venture?

"At present, there are 18 active trials assessing the efficacy of Enfortumab vedotin in 377 cities and 44 countries. The initial research involving this medication was done by Seagen Inc. back in 2014 with a cohort of 213 participants; since then, two additional studies have been conducted."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Enfortumab Vedotin as Monotherapy in Patients With Metastatic Castration-Resistant Prostate Cancer
2022. "Enfortumab Vedotin as Monotherapy in Patients With Metastatic Castration-Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04754191.
~5 spots leftby Sep 2024
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