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

Studio Clinico

Patologia: Carcinoma della vescica

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: 1, II

Richiesta mandatoria di tessuto: Sì

Linee di trattamento: Seconda linea

Criteri di inclusione: 

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.
- Arm A: 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.
- Arm A: 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.
- Arm B: PD-1/L1 refractory locally advanced or mUC as evidenced by: EITHER disease progression after treatment with an anti-PD-1/L1 mAb for locally advanced/unresectable or mUC administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies; OR disease recurrence after treatment with an anti-PD-1/L1 mAb for MIUC administered as monotherapy or in combination with other checkpoint therapies >12 months after last dose of treatment with an anti-PD-1/L1 mAb.
- Arm B: Participants must provide an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion from a metastatic site or from a primary tumor that has become locally advanced and not previously irradiated.

Criteri di esclusione: 

- 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.

Trattamento sperimentale: 

Arm A: Zilovertamab vedotin
Arm B: Pembrolizumab and MK-3120

Trattamento di controllo: 

 - 

Centri partecipanti

Nord Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2023-506384-34-00

Data di inserimento: 15.06.2026

Promotore

Merck Sharp & Dohme LLC

Principal Investigator ITALIA

Riferimento: Dr. - -

Telefono: 00000

Email: na@na.it

Localita: na