Brief 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)

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of Participants Who Experience an Adverse Event (AE)

Primary Outcome 1 - Timeframe: Up to approximately 27 months

Primary Outcome 2 - Measure: Number of Participants Who Experience a Dose Limiting Toxicity (DLT)

Primary Outcome 2 - Timeframe: Up to approximately 21 days

Primary Outcome 3 - Measure: Number of Participants Who Discontinue Study Treatment Due to an AE

Primary Outcome 3 - Timeframe: Up to approximately 24 months

Primary Outcome 4 - Measure: Objective Response Rate (ORR) as Assessed by Investigator

Primary Outcome 4 - Timeframe: Up to approximately 58 months

CONDITION

• Bladder Cancer

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Medical Director

Role: Study Director

Affiliation: Merck Sharp & Dohme LLC

Overall Contact

Name: Toll Free Number

Phone: 1-888-577-8839

Email: [email protected]

LOCATION