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Antibody-Drug Conjugate

Enfortumab Vedotin + Pembrolizumab for Bladder Cancer

Phase 2
Recruiting
Led By Pooja Ghatalia, MD
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new schedule for giving a cancer drug called Enfortumab Vedotin, alone and with another drug called pembrolizumab. It focuses on adults with advanced bladder cancer that has spread. Enfortumab Vedotin kills cancer cells directly, while pembrolizumab helps the immune system fight the cancer. Enfortumab Vedotin is an antibody-drug conjugate approved for patients with advanced urothelial cancer who previously received specific treatments.

Who is the study for?
Adults with advanced or metastatic urothelial cancer, who have measurable disease and are planning to receive Enfortumab Vedotin (EV) as standard treatment. They must be over 18, have finished any prior systemic therapy at least two weeks before, and be in a fair to good physical state (ECOG 0-2). Participants need normal organ/marrow function and must provide a tumor tissue sample if available.
What is being tested?
The trial is testing an alternative schedule for administering EV alone and in combination with Pembrolizumab in patients with advanced urothelial cancer. It's an open-label phase 2 study, meaning both researchers and participants know what treatments are given.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Duration of clinical benefit
Secondary study objectives
Overall survival
Time to next treatment

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: EV/pembrolizumabExperimental Treatment2 Interventions
EV will be administered at standard dose of 1.25 mg/kg IV on days 1 and 8 with pembrolizumab 200 mg IV on day 1 of a 21-day cycle for 6 cycles. Radiographic assessment will be conducted every 9 weeks. Schedule de-escalation of EV will occur in patients with disease control per RECIST v1.1 (complete response/partial response/stable disease) on their first scan in the EV/pembrolizumab arm at 9 weeks. In these patients EV and pembrolizumab will be administered on day 1 of a 21-day cycle.
Group II: Enfortumab vedotin (EV) monotherapyActive Control1 Intervention
EV will be administered at standard dose of 1.25 mg/kg IV on days 1, 8 and 15 of a 28-day cycle for 3 cycles. First schedule de-escalation of EV will occur in patients with disease control per RECIST v1.1 (complete response/partial response/stable disease) on their first scan in the EV at 12 weeks. In these patients, EV will be administered on days 1 and 15 of a 28-day cycle. Second schedule de-escalation of EV will occur in patients with disease control per RECIST v1.1 (complete response/partial response/stable disease) on their second scan in the EV monotherapy (at 24 weeks). EV will be administered on day 1 of a 21-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enfortumab vedotin
2017
Completed Phase 2
~240
Pembrolizumab
2017
Completed Phase 3
~3130

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
Enfortumab Vedotin is an antibody-drug conjugate targeting Nectin-4, delivering a cytotoxic agent directly to urothelial carcinoma cells to induce cell death. Pembrolizumab is a PD-1 inhibitor that enhances the immune system's ability to attack cancer by blocking the interaction between PD-1 on T cells and PD-L1 on cancer cells. These targeted therapies are significant for bladder cancer patients as they offer more effective and potentially less toxic treatment options compared to traditional chemotherapy.

Find a Location

Who is running the clinical trial?

Fox Chase Cancer CenterLead Sponsor
234 Previous Clinical Trials
39,303 Total Patients Enrolled
Pooja Ghatalia, MDPrincipal InvestigatorFox Chase Cancer Center
1 Previous Clinical Trials
81 Total Patients Enrolled

Media Library

Enfortumab Vedotin (Antibody-Drug Conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT05923190 — Phase 2
Bladder Cancer Research Study Groups: Enfortumab vedotin (EV) monotherapy, EV/pembrolizumab
Bladder Cancer Clinical Trial 2023: Enfortumab Vedotin Highlights & Side Effects. Trial Name: NCT05923190 — Phase 2
Enfortumab Vedotin (Antibody-Drug Conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05923190 — Phase 2
~47 spots leftby Jul 2028