NCT02364076

Pembrolizumab and Epacadostat in Patients With Thymic Carcinoma

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Thymic Carcinoma
• Thymus Neoplasms
• Thymus Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Administration of 200 mg MK-3475 once every 3 weeks
DRUG	Epacadostat	100mg taken by mouth twice daily

Timeline

• Start date: 2015-03-01
• Primary completion: 2019-06-01
• Completion: 2021-12-01
• First posted: 2015-02-16
• Last updated: 2019-12-13
• Results posted: 2019-12-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study