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Antibody-Drug Conjugate

Enfortumab Vedotin for Bladder Cancer (EV-103 Trial)

Phase 1 & 2
Waitlist Available
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
Dose-escalation cohorts: Ineligible for first-line cisplatin-based chemotherapy and no prior treatment for la/mUC, or have disease progression following at least 1 platinum-containing treatment
Cohort B: Must have disease progression during/following treatment with at least 1 platinum-containing regimen for la/mUC or disease recurrence
Must not have
MIBC - Cohorts H, J, and L: Participant has undergone partial cystectomy of the bladder to remove any NMIBC or MIBC
MIBC - Cohorts H, J, and L: Received any prior treatment with a CPI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug called enfortumab vedotin alone and with other treatments in patients with advanced or muscle-invasive bladder cancer. The goal is to see how well these treatments work and what side effects they might have. Enfortumab vedotin targets and kills cancer cells, while pembrolizumab helps the immune system fight the cancer.

Who is the study for?
This trial is for adults with advanced or muscle-invasive urothelial cancer, including bladder and other urinary cancers. Participants should be eligible for certain chemotherapy drugs like cisplatin or carboplatin, and some may also qualify for pembrolizumab treatment. They must not have received specific prior treatments, have a good performance status (able to carry out daily activities), and an expected lifespan of at least 3 months.
What is being tested?
The study tests enfortumab vedotin alone or combined with anticancer therapies such as pembrolizumab, cisplatin, carboplatin, and gemcitabine. It aims to see if these treatments can shrink the cancer in patients with locally advanced or metastatic urothelial cancer as well as those with muscle-invasive bladder cancer.
What are the potential side effects?
Possible side effects include reactions related to the immune system affecting organs, infusion-related reactions from the drug entering the body, fatigue, digestive issues like nausea or diarrhea, blood disorders that affect cell counts and increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can't have cisplatin and haven't been treated for advanced bladder cancer, or my cancer got worse after platinum treatment.
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My cancer got worse or came back after treatment with a platinum-based drug.
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I can take care of myself and am up and about more than half of my waking hours.
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My bladder cancer diagnosis was confirmed through tissue examination.
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I cannot receive cisplatin as a treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had surgery to remove part of my bladder for cancer.
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I have had prior treatment with a checkpoint inhibitor.
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I have ongoing nerve issues in my senses or movements that are moderate to severe.
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I am not on high doses of steroids or other drugs that weaken my immune system.
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I have been treated with enfortumab vedotin or similar drugs before.
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I am experiencing significant side effects from previous cancer treatments.
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I am on high doses of steroids or other drugs that weaken my immune system.
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I have had treatment with enfortumab vedotin or similar drugs for bladder cancer.
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I had another type of cancer within the last 3 years.
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I have had treatment for muscle invasive bladder cancer before.
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My cancer has spread to my brain or spinal cord.
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My diabetes is not under control.
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I have ongoing nerve issues in my senses or movements that are moderate to severe.

Timeline

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
Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) (Cohort K only)
Pathological complete response (pCR) rate per central pathology review (MIBC cohorts only)
Type, incidence, and severity of laboratory abnormalities (Dose escalation and Expansion Parts 1 to 3 cohorts only)
+1 more
Secondary study objectives
Confirmed ORR by BICR according to RECIST 1.1 (Dose escalation and Cohort A only)
Confirmed ORR by investigator assessment according to RECIST 1.1 (la/mUC cohorts only)
Confirmed ORR by investigator assessment per the modified RECIST 1.1 for immune-based therapeutics (iRECIST) (Dose escalation and Part 1-3 cohorts with pembrolizumab only)
+29 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

12Treatment groups
Experimental Treatment
Group I: Randomized Cohort K: Enfortumab Vedotin MonotherapyExperimental Treatment1 Intervention
Enfortumab vedotin on days 1 and 8 every 21 days
Group II: Randomized Cohort K: Enfortumab Vedotin + PembrolizumabExperimental Treatment2 Interventions
Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
Group III: Optional Cohort J:EV+Pembrolizumab in MIBC neoadjuvant settingExperimental Treatment2 Interventions
Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
Group IV: Optional Cohort F: Enfortumab Vedotin+Gemcitabine in 1L and 2LExperimental Treatment2 Interventions
Enfortumab vedotin and gemcitabine on days 1 and 8 every 21 days
Group V: Optional Cohort B: Enfortumab Vedotin + Pembrolizumab in 2LExperimental Treatment2 Interventions
Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
Group VI: EV + Pembrolizumab in cisplatin-ineligible 1L and in 2LExperimental Treatment2 Interventions
Dose Escalation: Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
Group VII: Cohort L: Enfortumab vedotin in MIBC in perioperative settingExperimental Treatment1 Intervention
Enfortumab vedotin on days 1 and 8 and every 21 days
Group VIII: Cohort H: Enfortumab vedotin in MIBC neoadjuvant settingExperimental Treatment1 Intervention
Enfortumab vedotin on days 1 and 8 every 21 days
Group IX: Cohort G: Enfortumab Vedotin + Platinum + Pembrolizumab in 1LExperimental Treatment4 Interventions
Enfortumab vedotin on days 1 and 8 plus cisplatin or carboplatin on day 1 plus pembrolizumab on day 1 every 21 days
Group X: Cohort E: Enfortumab Vedotin + Carboplatin in 1LExperimental Treatment2 Interventions
Enfortumab vedotin on days 1 and 8 plus carboplatin on day 1 every 21 days
Group XI: Cohort D: Enfortumab Vedotin + Cisplatin in 1LExperimental Treatment2 Interventions
Enfortumab vedotin on days 1 and 8 plus cisplatin on day 1 every 21 days
Group XII: Cohort A: EV + Pembrolizumab in cisplatin-ineligible 1LExperimental Treatment2 Interventions
Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
carboplatin
2010
Completed Phase 3
~4790
gemcitabine
2013
Completed Phase 3
~4260
pembrolizumab
2017
Completed Phase 3
~6070
cisplatin
1997
Completed Phase 3
~3290

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 often include chemotherapy, immunotherapy, and targeted therapies. Enfortumab Vedotin, an antibody-drug conjugate targeting Nectin-4, works by delivering a cytotoxic agent directly to cancer cells expressing Nectin-4, thereby minimizing damage to healthy cells. Immunotherapies like pembrolizumab and atezolizumab inhibit PD-1/PD-L1 pathways, enhancing the immune system's ability to attack cancer cells. These treatments are crucial for bladder cancer patients as they offer targeted approaches that can improve efficacy and reduce side effects compared to traditional chemotherapy, potentially leading to better outcomes and quality of life.
[The role of immunotherapy in the modern treatment of urothelial carcinoma].

Find a Location

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
199 Previous Clinical Trials
122,006 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,981 Previous Clinical Trials
5,177,661 Total Patients Enrolled
Seagen Inc.Industry Sponsor
210 Previous Clinical Trials
73,942 Total Patients Enrolled

Media Library

Enfortumab Vedotin (Antibody-Drug Conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT03288545 — Phase 1 & 2
Bladder Cancer Research Study Groups: Cohort H: Enfortumab vedotin in MIBC neoadjuvant setting, Randomized Cohort K: Enfortumab Vedotin + Pembrolizumab, Cohort L: Enfortumab vedotin in MIBC in perioperative setting, Randomized Cohort K: Enfortumab Vedotin Monotherapy, Optional Cohort J:EV+Pembrolizumab in MIBC neoadjuvant setting, Cohort D: Enfortumab Vedotin + Cisplatin in 1L, Cohort E: Enfortumab Vedotin + Carboplatin in 1L, Optional Cohort F: Enfortumab Vedotin+Gemcitabine in 1L and 2L, Cohort G: Enfortumab Vedotin + Platinum + Pembrolizumab in 1L, EV + Pembrolizumab in cisplatin-ineligible 1L and in 2L, Cohort A: EV + Pembrolizumab in cisplatin-ineligible 1L, Optional Cohort B: Enfortumab Vedotin + Pembrolizumab in 2L
Bladder Cancer Clinical Trial 2023: Enfortumab Vedotin Highlights & Side Effects. Trial Name: NCT03288545 — Phase 1 & 2
Enfortumab Vedotin (Antibody-Drug Conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03288545 — Phase 1 & 2
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