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)
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.
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.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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 who have the cancer respond (cancer gets smaller or goes away) with the new study treatment when given with standard treatment.
Trial Locations
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City
State
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Status
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…
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)
* 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
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* 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
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