What is the mechanism of action of this treatment?

Enfortumab Vedotin and Pembrolizumab represent advanced treatment options for Bladder Adenocarcinoma. Enfortumab Vedotin targets Nectin-4, delivering cytotoxic agents directly to cancer cells, thereby reducing collateral damage to healthy cells. Pembrolizumab, a checkpoint inhibitor, blocks the PD-1 pathway, enhancing the immune system's ability to attack cancer cells. These targeted and immune-based therapies are significant for patients as they promise more effective and less toxic alternatives to conventional chemotherapy.

What side effects are associated with this type of intervention?

The most common treatments for Bladder Adenocarcinoma, such as Enfortumab Vedotin and Pembrolizumab, have distinct side effect profiles. Enfortumab Vedotin often causes fatigue, peripheral neuropathy, rash, and hyperglycemia. Pembrolizumab, on the other hand, is associated with immune-related adverse events including colitis, pneumonitis, hepatitis, endocrinopathies, and skin reactions. Patients receiving these treatments should be closely monitored for these potential side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for bladder cancer, including checkpoint inhibitors and antibody-drug conjugates. Pembrolizumab, a checkpoint inhibitor blocking the PD-1 pathway, has been approved for the treatment of advanced urothelial carcinoma, a common type of bladder cancer. Additionally, Enfortumab Vedotin, an antibody-drug conjugate targeting Nectin-4, has also received FDA approval for the treatment of locally advanced or metastatic urothelial cancer. These approvals highlight the effectiveness of targeting specific pathways and proteins in the treatment of bladder cancer.

What other types of research exist?

Promising novel alternatives for Bladder Adenocarcinoma patients in 2024 include Atezolizumab (an anti-PD-L1 therapy) and combination therapies involving Nivolumab (an anti-PD-1 therapy) with Ipilimumab (an anti-CTLA-4 therapy). Additionally, targeted therapies such as Erdafitinib (a fibroblast growth factor receptor inhibitor) and Sacituzumab Govitecan (an antibody-drug conjugate targeting Trop-2) are also emerging as potential options.

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Antibody-Drug Conjugate

Enfortumab Vedotin + Pembrolizumab for Testicular and Urinary Tract Cancer

Phase 2

Waitlist Available

Led By Andrea B Apolo, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have histologically confirmed locally advanced or metastatic pure adenocarcinoma of the urinary tract, pure squamous cell carcinoma of the urinary tract, or treatment-refractory testicular germ cell tumors

Participants in Cohorts A2, B2, and C2 must be immune checkpoint inhibitor naive

Must not have

Symptomatic or untreated central nervous system (CNS) metastases

Participants with prior investigational drug, chemotherapy, immunotherapy, or any prior radiotherapy (except for palliative bone directed therapy) within the past 2 weeks prior to the first study drug administration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose through 30 days after last treatment with ev and 90 days after last treatment with pembrolizumab

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of two drugs, enfortumab vedotin and pembrolizumab, in adults with rare testicle or urinary tract cancers. Enfortumab vedotin targets and kills cancer cells, while pembrolizumab boosts the immune system to fight the cancer. The goal is to see if this combination can help patients who have not responded to other treatments.

Who is the study for?

Adults with rare testicular or urinary tract cancers, including advanced adenocarcinoma and squamous cell carcinoma of the urinary tract, or refractory testicular germ cell tumors. Must have measurable disease and be in good physical condition (ECOG <=1). Some must have had prior anti-PD-1/PD-L1 therapy; others should not have received immune checkpoint inhibitors before. Women must agree to contraception use and discontinue breastfeeding.

What is being tested?

The trial is testing Enfortumab Vedotin (EV), alone or combined with Pembrolizumab, for treating certain rare genitourinary cancers. Participants will receive treatments through an IV at varying intervals over cycles lasting several weeks, potentially continuing up to five years, accompanied by regular scans and tests.

What are the potential side effects?

Possible side effects include reactions where the drug enters the body, tiredness, changes in skin appearance or sensation (like numbness), eye problems like keratitis or ulcers if predisposed, blood sugar levels that could become hard to control for diabetics, and potential worsening of autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is a specific type found in the urinary tract or is a hard-to-treat testicular cancer.

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I have never received immune checkpoint inhibitor therapy.

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I am mostly self-sufficient and can carry out daily activities.

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I am 18 years old or older.

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My cancer has spread or worsened, as shown by recent scans.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have brain metastases that are causing symptoms or have not been treated.

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I haven't had any cancer treatment or investigational drugs in the last 2 weeks.

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I have been treated with EV or MMAE-based drugs before.

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I have an active eye infection or corneal ulcer.

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I have moderate to severe nerve damage in my senses or movements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose through 30 days after last treatment with ev and 90 days after last treatment with pembrolizumab

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose through 30 days after last treatment with ev and 90 days after last treatment with pembrolizumab

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose through 30 days after last treatment with ev and 90 days after last treatment with pembrolizumab for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate (ORR)

Secondary study objectives

Clinical benefit rate (CBR)

Duration of response (DoR)

Overall survival (OS)

+3 more

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

Group I: Arm 2Experimental Treatment2 Interventions

Treatment with enfortumab vedotin and pembrolizumab

Group II: Arm 1Experimental Treatment1 Intervention

Treatment with enfortumab vedotin

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~2810

Enfortumab vedotin

2017

Completed Phase 2

~240

0 / 10Eligibility criteria met

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 and Pembrolizumab represent advanced treatment options for Bladder Adenocarcinoma. Enfortumab Vedotin targets Nectin-4, delivering cytotoxic agents directly to cancer cells, thereby reducing collateral damage to healthy cells. Pembrolizumab, a checkpoint inhibitor, blocks the PD-1 pathway, enhancing the immune system's ability to attack cancer cells. These targeted and immune-based therapies are significant for patients as they promise more effective and less toxic alternatives to conventional chemotherapy.