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)
Purpose
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.
Condition
- Bladder Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm A: MK-3120 + Enfortumab Vedotin (EV) + Pembrolizumab |
Participants will receive MK-3120 administered intravenously on Day 1 and Day 8 of each 3-week cycle and EV administered intravenously on Day 1 and Day 8 of each 3-week cycle until documented disease progression or any other discontinuation criterion is met and Pembrolizumab 200 mg administered intravenously on Day 1 of each 3-week cycle for up to 35 cycles (~2 years). |
|
Recruiting Locations
San Francisco, California 94158
Study Coordinator
415-699-7286
Cleveland, Ohio 44195
Study Coordinator
216-444-8311
Salt Lake City, Utah 84112-5550
Study Coordinator
801-585-0155
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC
Detailed Description
This is a substudy of the master protocol MK-3475-U04 (KEYMAKER-U04)