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A Study of Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Plus Enfortumab Vedotin (EV) With and Without Pembrolizumab in Advanced Urothelial Carcinoma (MK-3475-04C/KEYMAKER-U04)

Sponsored by Merck Sharp & Dohme LLC

Quick Self-Assessment

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Current Status

Active, Not Recruiting

Auto-verified from ClinicalTrials.gov

Verified Feb 18, 2026

Phase

Clinical Trial

Sponsor

Merck Sharp & Dohme LLC

Enrollment Target

98

Start Date

Jul 2024

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1 of 98 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

This study is a substudy being conducted under one pembrolizumab umbrella master study KEYMAKER-U04. The substudy will consist of 2 parts. Part 1 will evaluate the safety and preliminary efficacy of sacituzumab tirumotecan plus enfortumab vedotin (EV). Part 2 will be based on Part 1 results and will evaluate the efficacy, pharmacokinetics, and safety of sacituzumab tirumotecan plus EV in combination with pembrolizumab in participants with advanced urothelial carcinoma.

Who Can Participate

Inclusion Criteria

The main inclusion criteria include but are not limited to the following:
Must have histologically documented, locally advanced/metastatic urothelial carcinoma (la/mUC).
Must provide an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion demonstrating UC, not previously irradiated, and adequate for biomarker evaluation. A newly obtained biopsy is strongly preferred, but not required if archival tissue is evaluable.
Any AEs due to previous anticancer therapies must have recovered to ≀Grade 1 or baseline. Endocrine-related AEs adequately treated with hormone replacement are eligible.
PART 1 ONLY: Participants must have received platinum-based chemotherapy for treatment of la/mUC.
PART 1 ONLY: Participants must not have received \>2 lines of therapy for la/mUC. Platinum-based chemotherapy followed by avelumab maintenance is considered 2 lines of therapy.
PART 2 ONLY: Participants must not have received prior systemic

❓ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

98 participants

⚧

Gender

ALL

🏒

Sponsor

Merck Sharp & Dohme LLC

Study Locations

Choose your preferred location or select flexible during enrollment

Unknown

San Francisco

California

Location available
View San Francisco location page
Unknown

Chicago

Illinois

Location available
View Chicago location page
Unknown

Indianapolis

Indiana

Location available
View Indianapolis location page
Unknown

Boston

Massachusetts

Location available
View Boston location page
Unknown

St Louis

Missouri

Location available
View St Louis location page
Unknown

New York

New York

Location available
View New York location page
Unknown

Cleveland

Ohio

Location available
View Cleveland location page
Unknown

Salt Lake City

Utah

Location available
View Salt Lake City location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

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Looking for Bladder Cancer Treatment in San Francisco?

Join others in California exploring innovative treatment options through clinical research

Bladder Cancer Treatment Options in San Francisco, California

If you're searching for Bladder Cancer treatment in San Francisco, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in San Francisco, Chicago, Indianapolis and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Bladder Cancer. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 98 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Bladder Cancer?

Potential Benefits

  • βœ“Access to new treatment approaches before public availability
  • βœ“Close monitoring by experienced medical professionals
  • βœ“Study-related care provided at no cost
  • βœ“Contribute to medical research for Bladder Cancer

What to Expect

  • β†’Initial screening to determine eligibility
  • β†’Regular check-ups and monitoring visits
  • β†’Possible compensation for time and travel
  • β†’You can withdraw at any time

Frequently Asked Questions About This Bladder Cancer Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06483334. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.