NCT04224740 - Pembrolizumab Combined With Cisplatin-based Chemotherapy as First-line Systemic Therapy in Advanced Penile Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 15, 2020

Primary Completion Date

November 13, 2023

Study Completion Date

November 13, 2023

Conditions

Penile Carcinoma

Interventions

DRUG

Pembrolizumab

Patients will receive pembrolizumab at the dose of 200mg IV Q3W with maximum duration of 2 years (34 cycles-counting the part combined with chemotherapy)

DRUG

Standard of care therapy

Ciplastin 70mg/m² IV D1(or carboplatin AUC 5) plus 5-Fluouracil 1000mg/m²/day IV( continuous infusion on Days 1-4) Q3W for 6 cycles

Trial Locations (11)

60.135-237

Oncocentro Ceará (Rede D'or), Fortaleza

60.430-230

ICC - Instituto do Câncer do Ceará, Fortaleza

70.840-901

Hospital Universitário de Brasília (HUB-UnB), Brasília

81.520-060

Hospital Erasto Gaertner, Curitiba

66.053-000

COB - Clínica Oncológica do Brasil, Belém

90.619-900

CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS, Porto Alegre

14.784-400

Hospital de Amor de Barretos, Barretos

20.230-130

INCA - Instituto Nacional de Câncer, Barretos

17.210-070

Hospital Amaral Carvalho de Jaú, Jaú

01.246-000

ICESP - Instituto do Câncer do Estado de São Paulo, São Paulo

01.323-030

BP - A Beneficência Portuguesa de São Paulo, São Paulo

All Listed Sponsors

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Latin American Cooperative Oncology Group

OTHER