What side effects are associated with this type of intervention?

Common treatments for bladder cancer, such as enfortumab vedotin and pembrolizumab, have distinct side effect profiles. Enfortumab vedotin can cause neuropathy, alopecia, rash, decreased appetite, and dysgeusia. Pembrolizumab, a PD-1 inhibitor, is associated with immune-related adverse events including thyroid dysfunction, pneumonitis, colitis, hepatitis, and nephritis. Patients should discuss these potential side effects with their healthcare provider to make informed treatment decisions.

What prior FDA approvals exist?

The FDA has approved several treatments for bladder cancer, including Enfortumab Vedotin and Pembrolizumab. Enfortumab Vedotin, an antibody-drug conjugate targeting Nectin-4, is approved for patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor and platinum-containing chemotherapy. Pembrolizumab, a PD-1 inhibitor, is approved for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy or have disease progression during or following platinum-containing chemotherapy. These approvals highlight the use of targeted therapies and immune checkpoint inhibitors in the treatment of bladder cancer.

What other types of research exist?

Promising novel alternatives for bladder cancer treatment in 2024 include: 1) Nivolumab (PD-1 inhibitor) and Ipilimumab (CTLA-4 inhibitor) combination therapy, which has shown efficacy in various cancers including urothelial carcinoma. 2) Avelumab (PD-L1 inhibitor), which has demonstrated activity in urothelial carcinoma. 3) Experimental approaches such as chimeric antigen receptor (CAR)-T cell therapies, which are being tested in clinical trials and may offer new treatment avenues for eligible patients.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

~3150

Do I qualify?Apply below to find out

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.