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)
This is a substudy of the master protocol MK-3475-U04 (KEYMAKER-U04)
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 viral load before randomization
If participant has a history of hepatitis C virus (HCV), has undetectable HCV viral load before randomization
You may not be if
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
Clareo Health | 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)
