Enfortumab Vedotin for Bladder Cancer
(EV-103 Trial)
Recruiting in Palo Alto (17 mi)
+105 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: Astellas Pharma Global Development, Inc.
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
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.Inclusion Criteria
If you are in Cohort J, H, or L, you have not received certain types of treatments for MIBC, but may have had specific bladder treatments in the past. If you are in Cohort J, you may be eligible for pembrolizumab.
I am eligible for pembrolizumab treatment.
You are expected to live for at least 3 more months.
+17 more
Exclusion Criteria
I have received PD-1, PD-L1, or PD-L2 inhibitors, except if I'm in Cohort F.
I have not taken drugs like CD137 agonists, OX-40 agonists, or CTLA-4 inhibitors for my cancer, except if I'm in Cohort F.
I have had prior treatment with a checkpoint inhibitor.
+14 more
Participant Groups
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.
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
Enfortumab Vedotin is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Padcev for:
- Locally advanced or metastatic urothelial cancer
🇪🇺 Approved in European Union as Padcev for:
- Locally advanced or metastatic urothelial cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Memorial Sloan Kettering Cancer Center - WestchesterHarrison, NY
Vidant Medical CenterGreenville, NC
Gabrail Cancer Center Research, LLCCanton, OH
Saint Francis Hospital Cancer CenterGreenville, SC
More Trial Locations
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Who Is Running the Clinical Trial?
Astellas Pharma Global Development, Inc.Lead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
Seagen Inc.Industry Sponsor