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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)

55 patients around the world

Available in Chile, United States

This is a substudy of the master protocol MK-3475-U04 (KEYMAKER-U04)

Merck Sharp & Dohme LLC

1Research sites

55Patients around the world

This study is for people with

Bladder Cancer

Urothelial cancer

From 18 Years

All Gender

: 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 (e.g., 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.

Instituto Oncológico FALP (Fundación Arturo López Pérez)

Recruiting

José Manuel Infante 805, Providencia, Región Metropolitana, Santiago

StudyMK-3475-04D/KEYMAKER-U04

SponsorMerck Sharp & Dohme LLC

Study typeInterventional

Conditions

Bladder CancerUrothelial cancer

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT07232602