Pembrolizumab and Epacadostat in Patients With Thymic Carcinoma
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 17
Summary
- Conditions
- Thymic Carcinoma
- Thymus Cancer
- Thymus Neoplasms
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The amended phase II study of pembrolizumab and epacadostat is for thymic carcinoma patients who recurred after at least one prior chemotherapy regimen. The primary endpoint is response rate; secondary endpoints are Progression-Free Survival, Overall Survival and treatment tolerability. Responses wi...
The amended phase II study of pembrolizumab and epacadostat is for thymic carcinoma patients who recurred after at least one prior chemotherapy regimen. The primary endpoint is response rate; secondary endpoints are Progression-Free Survival, Overall Survival and treatment tolerability. Responses will be assessed according to RECIST 1.1; progression-free survival is defined as time between start of treatment and tumor progression or death; survival is the time between start of treatment and death. Furthermore exploratory studies will be performed on archival tumor material (PDL-1 expression, next-generation sequencing), and fresh biopsies (culturing; next-generation sequencing).
Tracking Information
- NCT #
- NCT02364076
- Collaborators
- Merck Sharp & Dohme Corp.
- Incyte Corporation
- Investigators
- Principal Investigator: Giuseppe Giaccone, MD PhD Georgetown University