New Treatments with Enfortumab Vedotin for Bladder Cancer

KEYMAKER-U04 Substudy 04D: A Clinical Study of New Treatments Given With Enfortumab Vedotin and Pembrolizumab in People With Urothelial Cancer (MK-3475-04D/KEYMAKER-U04)

Recruiting Phase 1 Phase 2 Interventional Study
Bladder Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
55 (estimated)
Sponsor
Merck Sharp & Dohme LLC · Industry
Who this trial is looking for

This trial is looking for people with advanced bladder cancer to test new treatment combinations. Participants will receive standard treatments along with new drugs to see how safe and effective they are.

Are You a Good Fit for This Trial?
Rules you out Severe dry eye syndromeActive keratitisInflammatory bowel diseaseCardiovascular diseaseUncontrolled diabetesSymptomatic fluid buildupActive autoimmune diseaseAdditional malignancy

You may be able to join if

  • I have bladder cancer that is advanced and cannot be removed surgically.
  • I will provide a recent tumor tissue sample.
  • I have not had previous treatment for my bladder cancer.
  • If I have HIV, I am on effective treatment.
  • If I have hepatitis B, I have received treatment for at least 4 weeks.
  • If I have hepatitis C, my viral load is undetectable.

You may not be able to join if

  • I have severe eye conditions that affect healing.
  • I have active eye infections.
  • I have uncontrolled digestive diseases.
  • I have serious heart or brain problems in the last 6 months.
  • I have uncontrolled diabetes.
  • I have serious fluid buildup in my body that needs drainage.
  • I have active autoimmune diseases requiring treatment.
  • I have current brain cancer or needed treatment for another cancer recently.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
Researchers are looking for new ways to treat people with urothelial cancer (UC) that is locally advanced or metastatic. The standard treatment for locally advanced or metastatic UC is enfortumab vedotin (EV) given with pembrolizumab. The goals of this study are to learn about: * The safety of the study treatment when given with standard treatment and if people tolerate it * The number of people…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically documented urothelial carcinoma (UC) that is locally advanced and unresectable or metastatic * Must provide a newly obtained or archival tumor tissue sample (core or excisional biopsy…
Contacts

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