Spots Global Cancer Trial Database for Pembrolizumab and Epacadostat in Patients With Thymic Carcinoma

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Pembrolizumab and Epacadostat in Patients With Thymic Carcinoma

Official Title: Pembrolizumab (MK-3475) and Epacadostat (INCB024360) in Thymic Carcinomas

Study ID: NCT02364076

Conditions

Thymic Carcinoma

Thymus Neoplasms

Thymus Cancer

Interventions

Pembrolizumab

Epacadostat

Study Description

Brief Summary: This is a non-randomized clinical trial in patients with thymic carcinomas who failed prior systemic therapy. All subjects will receive pembrolizumab and epacadostat treatment in three week cycles until unacceptable toxicity, death, progressive disease or withdrawal.

Detailed 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 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).