A Phase II Trial of Pembrolizumab Combined With Cisplatin-based Chemotherapy as First-line Systemic Therapy in Advanced Penile Cancer
Overview
- Phase
- Phase 2
- Intervention
- Pembrolizumab
- Conditions
- Penile Carcinoma
- Sponsor
- Latin American Cooperative Oncology Group
- Enrollment
- 37
- Locations
- 11
- Primary Endpoint
- Overall response rate (ORR)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Pembrolizumab plus standard of care chemotherapy
-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
Intervention: Pembrolizumab
Pembrolizumab plus standard of care chemotherapy
-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
Intervention: Standard of care therapy
Outcomes
Primary Outcomes
Overall response rate (ORR)
Time Frame: 24 weeks
Proportion of patients with partial or complete response by investigator-assessed RECIST v1.1
Secondary Outcomes
- Overall survival (OS)(36 months)
- Clinical Benefit Rate (CBR)(24 weeks)
- Health Related Quality of Life (QoL)(24 weeks)
- Progression Free Survival (PFS)(24 months)