Brief Title: A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A)

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Percentage of Participants Who Experienced At Least One Adverse Event (AE)

Primary Outcome 1 - Timeframe: Up to approximately 5 years

Primary Outcome 2 - Measure: Percentage of Participants Who Discontinued Study Treatment Due to an AE

Primary Outcome 2 - Timeframe: Up to approximately 5 years

Primary Outcome 3 - Measure: Objective Response Rate (ORR)

Primary Outcome 3 - Timeframe: Up to approximately 2 years

CONDITION

• Urothelial Carcinoma

ELIGIBILITY

Inclusion Criteria:
The main inclusion and exclusion criteria include but are not limited to the following:
Histologically or cytologically confirmed diagnosis of locally advanced/unresectable or mUC of the renal pelvis, ureter (upper urinary tract), bladder, or urethra.

- PD-1/L1 refractory locally advanced or mUC as evidenced by:
EITHER disease progression while on treatment or after treatment with an anti-PD-1/L1 monoclonal antibody (mAb) for locally advanced/unresectable or mUC administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies OR disease recurrence while on treatment or after treatment with an anti-PD-1/L1 mAb for muscle-invasive urothelial carcinoma (MIUC) administered as monotherapy.
Participants must provide an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion demonstrating UC, not previously irradiated, and adequate for biomarker evaluation.
Exclusion Criteria:
Known additional nonurothelial malignancy that is progressing or has required active treatment within 3 years prior to study randomization/allocation.

- Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation.

- Active infection requiring systemic therapy.

- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.

- Known history of human immunodeficiency virus (HIV).

- Known history of hepatitis B or known hepatitis C virus infection.

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: Medical Director

Phone: 1-888-577-8839

Email: Trialsites@merck.com

LOCATION