Clinical trial for Bladder Cancer
Official title 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)
ClinicalTrials.gov ID: NCT07232602
What this study is testing
What is MK-3120?
an investigational IV drug being studied as a potential treatment for locally advanced or metastatic urothelial (bladder) cancer
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether adding new treatments to standard enfortumab vedotin and pembrolizumab is safe and how many people see their cancer shrink.
- Who it's for
- You may be able to join if you have bladder cancer that has spread or cannot be removed.
- What's involved
- You would receive the standard drugs enfortumab vedotin and pembrolizumab plus the new study treatment. You will have doctor visits and tests to check safety and tumor response.
- Time commitment
- The study lasts several months with regular visits during treatment and follow‑up.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
- Must not have received prior systemic therapy for locally advanced or metastatic UC
- If infected with Human Immunodeficiency Virus (HIV), has well controlled HIV on antiretroviral therapy
- If positive for hepatitis B surface antigen, has received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV...
You likely can't join if
- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal...
- Has active keratitis or corneal ulcerations
- Has active inflammatory bowel disease requiring immunosuppressive medication, or previous history of inflammatory bowel disease (eg, Crohn's disease...
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention
- Has a history of uncontrolled diabetes
- Has pleural effusion, ascites, and/or pericardial effusion that are symptomatic or require repeated drainage
See the full eligibility criteria
- 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)
- Must not have received prior systemic therapy for locally advanced or metastatic UC
- If infected with Human Immunodeficiency Virus (HIV), has well controlled HIV on antiretroviral therapy
- If positive for hepatitis B surface antigen, has received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load before randomization
- If participant has a history of hepatitis C virus (HCV), has undetectable HCV viral load before randomization
- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing
- Has active keratitis or corneal ulcerations
- Has active inflammatory bowel disease requiring immunosuppressive medication, or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention
- Has a history of uncontrolled diabetes
- Has pleural effusion, ascites, and/or pericardial effusion that are symptomatic or require repeated drainage
- Has active autoimmune disease that has required systemic treatment in the past 2 years
- Has known additional malignancy that is progressing or has required active treatment within the past 2 years
- Has known active central nervous system metastases and/or carcinomatous meningitis
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids, or has current pneumonitis/interstitial lung disease
- Has an active infection requiring systemic therapy
- If infected with HIV, has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has concurrent active HBV and HCV infection
- Has a history of stem cell/solid organ transplant
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
- Chicago, Illinois, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Salt Lake City, Utah, United States
- Santiago, Region M. de Santiago, Chile
- Bordeaux, Gironde, France
- Haifa, Israel
- Petah Tikva, Israel
- Amsterdam, North Holland, Netherlands
- Rotterdam, South Holland, Netherlands
- Seoul, South Korea
- Barcelona, Spain
- Madrid, Spain
- London, London, City of, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States; Chicago, Illinois, United States; New York, New York, United States; Cleveland, Ohio, United States; Salt Lake City, Utah, United States; Santiago, Region M. de Santiago, Chile and 9 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.