Pembrolizumab Combined With Cisplatin-based Chemotherapy as First-line Systemic Therapy in Advanced Penile Cancer
- Conditions
- Penile Carcinoma
- Interventions
- Drug: Standard of care therapy
- Registration Number
- NCT04224740
- Lead Sponsor
- Latin American Cooperative Oncology Group
- Brief Summary
This is a phase II clinical trial evaluating activity, safety and patients reported outcomes of first-line pembrolizumab plus cisplatin (or carboplatin) plus 5-FU for patients with advanced penile squamous cell carcinoma.
The primary endpoint is overall responsa rate according to RECIST v1.1 at week 24.
- Detailed Description
Advanced penile squamous cell carcinoma is associated with dismal survival rates and a major impact on the quality of life. To date, unresectable or metastatic disease is managed by systemic therapy with platinum-based chemotherapy for patients with good performance status. The median PFS and OS on first-line platinum-based chemotherapy vary between 3-4 and 7-15 months, respectively. Chemotherapy induces objective responses in only 20-30% of penile cancer patients with rare complete responses and systemic treatment has not changed for decades. Therefore, this study's rationale is to explore the efficacy and safety of pembrolizumab combined with standard-of-care cisplatin(or carboplatin) plus 5-fluorouracil as part of the first-line therapy. Patients will receive pembrolizumab 200mg IV every three weeks with a maximum duration of 2 years (34 cycles-counting the combination with chemotherapy) in case of no progressive disease or intolerance. The investigators hypothesized that the combination of immunotherapy with standard cytotoxic chemotherapy may improve the overall response rate by RECIST v1.1 in this patient population.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 37
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pembrolizumab plus standard of care chemotherapy Standard of care therapy -Pembrolizumab combined with standard of care therapy * 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 Pembrolizumab plus standard of care chemotherapy Pembrolizumab -Pembrolizumab combined with standard of care therapy * 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
- Primary Outcome Measures
Name Time Method Overall response rate (ORR) 24 weeks Proportion of patients with partial or complete response by investigator-assessed RECIST v1.1
- Secondary Outcome Measures
Name Time Method Overall survival (OS) 36 months Time from enrollment to death due to any cause.
Clinical Benefit Rate (CBR) 24 weeks Proportion of patients who have complete, partial response or stable disease by investigator-assessed RECIST v1.1
Health Related Quality of Life (QoL) 24 weeks Comparison of initial and final scores of the European Organization for Research and Treatment (EORTC) C30 questionnaires.
Progression Free Survival (PFS) 24 months Time from enrollment to progression by investigator-assessed RECIST 1.1 or death
Trial Locations
- Locations (11)
Oncocentro Ceará (Rede D'or)
🇧🇷Fortaleza, Ceará, Brazil
ICC - Instituto do Câncer do Ceará
🇧🇷Fortaleza, Ceará, Brazil
Hospital Universitário de Brasília (HUB-UnB)
🇧🇷Brasília, Distrito Federal, Brazil
Hospital Erasto Gaertner
🇧🇷Curitiba, Paraná, Brazil
COB - Clínica Oncológica do Brasil
🇧🇷Belém, Pará, Brazil
CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Hospital de Amor de Barretos
🇧🇷Barretos, São Paulo, Brazil
INCA - Instituto Nacional de Câncer
🇧🇷Barretos, São Paulo, Brazil
Hospital Amaral Carvalho de Jaú
🇧🇷Jaú, São Paulo, Brazil
ICESP - Instituto do Câncer do Estado de São Paulo
🇧🇷São Paulo, Brazil
Scroll for more (1 remaining)Oncocentro Ceará (Rede D'or)🇧🇷Fortaleza, Ceará, Brazil