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Antibody-Drug Conjugate

Enfortumab Vedotin + Pembrolizumab for Testicular and Urinary Tract Cancer

Q: Can individuals over the age of thirty be included in this experiment?

Eligible applicants for this trial must be at least 18 years of age and not exceed the age of 120.

Q: Could I qualify to participate in this research program?

Eligibility for this experiment is limited to individuals between 18 and 120 years of age who have been diagnosed with bladder adenocarcinoma. The trial will seek out 68 participants in total.

Q: Has Arm 1 been greenlit by the FDA?

According to our assessment, the safety of Arm 1 is rated a 2 since it's currently in Phase 2. This implies there are some favourable results regarding safety but no evidence that it works so far.

Q: Is enrollment still available to those who would like to participate in this experiment?

At the present time, this clinical trial is not enrolling participants. The initial posting to clinicaltrials.gov was made on September 28th 2023 and most recently edited on September 22nd 2023. Despite that, there are 381 other medical trials actively recruiting patients right now.

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

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

Study Summary

This trial will test a combination of drugs to treat rare cancers of the testicles & urinary tract in 18+ y/o. Participants will receive treatments 3 or 2 times in 28-week or 21-day cycles. Follow-up visits will be every 3-4 wks & by phone every 3 months for up to 5 yrs after.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective response rate (ORR)

Secondary outcome measures

Clinical benefit rate (CBR)

Duration of response (DoR)

Overall survival (OS)

+3 more

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

Enfortumab vedotin

2017

Completed Phase 2

~240

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,657 Previous Clinical Trials

40,933,599 Total Patients Enrolled

4 Trials studying Bladder Adenocarcinoma

1,088 Patients Enrolled for Bladder Adenocarcinoma

Andrea B Apolo, M.D.Principal InvestigatorNational Cancer Institute (NCI)

11 Previous Clinical Trials

1,300 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can individuals over the age of thirty be included in this experiment?

"Eligible applicants for this trial must be at least 18 years of age and not exceed the age of 120."

Answered by AI

Could I qualify to participate in this research program?

"Eligibility for this experiment is limited to individuals between 18 and 120 years of age who have been diagnosed with bladder adenocarcinoma. The trial will seek out 68 participants in total."

Answered by AI

Has Arm 1 been greenlit by the FDA?

"According to our assessment, the safety of Arm 1 is rated a 2 since it's currently in Phase 2. This implies there are some favourable results regarding safety but no evidence that it works so far."

Answered by AI

Is enrollment still available to those who would like to participate in this experiment?

"At the present time, this clinical trial is not enrolling participants. The initial posting to clinicaltrials.gov was made on September 28th 2023 and most recently edited on September 22nd 2023. Despite that, there are 381 other medical trials actively recruiting patients right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Enfortumab Vedotin With or Without Pembrolizumab in Rare Genitourinary Tumors (E-VIRTUE)

2024. "Enfortumab Vedotin With or Without Pembrolizumab in Rare Genitourinary Tumors (E-VIRTUE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06041503.

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