PEMBROLIZUMAB for Urothelial carcinoma

Inclusion criteria

• {"criterion_text":"- Has histologically documented urothelial carcinoma (UC) that is locally advanced and unresectable or metastatic\n- Must provide a newly obtained or archival tumor tissue sample (core or excisional biopsy)\n- Must not have received prior systemic therapy for locally advanced or metastatic UC\n- If infected with Human Immunodeficiency Virus (HIV), has well controlled HIV on antiretroviral therapy\n- 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\n- If participant has a history of hepatitis C virus (HCV), has undetectable HCV viral load before randomization"}

Exclusion criteria

• {"criterion_text":"- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing\n- Has active keratitis or corneal ulcerations\n- Has active inflammatory bowel disease requiring immunosuppressive medication, or previous history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea)\n- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention\n- Has a history of uncontrolled diabetes\n- Has pleural effusion, ascites, and/or pericardial effusion that are symptomatic or require repeated drainage\n- Has active autoimmune disease that has required systemic treatment in the past 2 years\n- Has known additional malignancy that is progressing or has required active treatment within the past 2 years\n- Has known active central nervous system metastases and/or carcinomatous meningitis\n- Has a history of stem cell/solid organ transplant\n- Has active keratitis or corneal ulcerations\n- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids, or has current pneumonitis/interstitial lung disease\n- Has an active infection requiring systemic therapy\n- If infected with HIV, has a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease\n- Has concurrent active HBV and HCV infection"}

Primary endpoints

• {"endpoint_text":"- Number of Participants Who Experienced At Least One Adverse Event (AE)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of Participants with Dose-limiting Toxicities","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of Participants Who Discontinued Study Treatment Due to an AE","definition_or_measurement_approach":""}
• {"endpoint_text":"- Objective Response Rate (ORR) as Assessed by Investigator","definition_or_measurement_approach":"Assessed by investigator per RECIST 1.1 (ORR per RECIST 1.1 as described in main objectives)"}

Secondary endpoints

• {"endpoint_text":"- Duration of Response (DOR) as Assessed by Investigator","definition_or_measurement_approach":"Assessed by investigator (DOR per RECIST 1.1 referenced in objectives)"}
• {"endpoint_text":"- Serum Maximum Concentration (Cmax) of MK-3120 Antibody-Drug Conjugate (ADC)","definition_or_measurement_approach":"Serum Cmax measurement of MK-3120 ADC"}
• {"endpoint_text":"- Serum Trough Concentration (Ctrough) of MK-3120 ADC","definition_or_measurement_approach":"Serum Ctrough measurement of MK-3120 ADC"}
• {"endpoint_text":"- Serum Cmax of MK-3120 Total Antibodies (TAb)","definition_or_measurement_approach":"Serum Cmax measurement of MK-3120 total antibodies"}
• {"endpoint_text":"- Serum Ctrough of MK-3120 TAb","definition_or_measurement_approach":"Serum Ctrough measurement of MK-3120 total antibodies"}
• {"endpoint_text":"- Plasma Cmax of MK-3120 Free Payload","definition_or_measurement_approach":"Plasma Cmax measurement of MK-3120 free payload"}
• {"endpoint_text":"- Plasma Ctrough of MK-3120 Free Payload","definition_or_measurement_approach":"Plasma Ctrough measurement of MK-3120 free payload"}
• {"endpoint_text":"- Serum Cmax of Enfortumab Vedotin (EV) ADC","definition_or_measurement_approach":"Serum Cmax measurement of enfortumab vedotin ADC"}
• {"endpoint_text":"- Serum Ctrough of EV ADC","definition_or_measurement_approach":"Serum Ctrough measurement of enfortumab vedotin ADC"}
• {"endpoint_text":"- Serum Cmax of EV TAb","definition_or_measurement_approach":"Serum Cmax measurement of enfortumab vedotin total antibodies"}
• {"endpoint_text":"- Serum Ctrough of EV TAb","definition_or_measurement_approach":"Serum Ctrough measurement of enfortumab vedotin total antibodies"}
• {"endpoint_text":"- Plasma Cmax of EV Free Payload","definition_or_measurement_approach":"Plasma Cmax measurement of enfortumab vedotin free payload"}
• {"endpoint_text":"- Plasma Ctrough of EV Free Payload","definition_or_measurement_approach":"Plasma Ctrough measurement of enfortumab vedotin free payload"}

Netherlands

Earliest CTIS Part Ii Submission Date

06-01-2026

Latest Decision Or Authorization Date

30-03-2026

Processing Time Days

83

Number Of Sites

2

Number Of Participants

6

Spain

Earliest CTIS Part Ii Submission Date

07-01-2026

Latest Decision Or Authorization Date

13-04-2026

Processing Time Days

96

Number Of Sites

2

Number Of Participants

6

France

Earliest CTIS Part Ii Submission Date

19-12-2025

Latest Decision Or Authorization Date

31-03-2026

Processing Time Days

102

Number Of Sites

1

Number Of Participants

4

Primary sponsor

Full Name

Merck Sharp & Dohme LLC

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Parexel International Corp.

Responsibilities

EUB services (call center and medical services)

Name

PPD Development LP

Responsibilities

Laboratory analysis - 3120 serum and plasma; Laboratory analysis - EV serum and plasma

Name

Fortrea Inc.

Responsibilities

code:1

Name

Almac Clinical Technologies LLC

Responsibilities

code:3

Name

QPS LLC

Responsibilities

code:4

Name

Almac Diagnostic Services Limited

Responsibilities

code:4

Name

Q Squared Solutions Holdings LLC

Responsibilities

Central Laboratory

Name

Hematogenix Laboratory Services LLC

Responsibilities

code:4

Third parties

• {"country":"United States","full_name":"Hematogenix Laboratory Services LLC","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"code:3","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"code:15; Laboratory analysis - 3120 serum and plasma","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"QPS LLC","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Diagnostic Services Limited","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"code:15; Laboratory analysis - EV serum and plasma","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"code:15; EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Q Squared Solutions Holdings LLC","duties_or_roles":"code:15; Central Laboratory","organisation_type":"Laboratory/Research/Testing facility"}