NCT03196232

Epacadostat and Pembrolizumab in Treating Patients With Metastatic or Unresectable Gastroesophageal Junction or Gastric Cancer

Phase 2 Study of Epacadostat (INCB024360) With Pembrolizumab (MK3475) in Metastatic or Unresectable Gastroesophageal Junction and Gastric Adenocarcinoma Requiring Paired Biopsies

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: George Albert Fisher · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase 2 trial evaluates the benefit of epacadostat plus pembrolizumab in combination to treat patients with gastroesophageal junction or gastric cancer that has spread to other parts of the body and cannot be removed by surgery. Epacadostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Giving epacadostat and pembrolizumab may work better in treating patients with gastroesophageal junction or gastric cancer.

Detailed description

Patients receive epacadostat orally (PO) twice daily (BID) on Days 1 to 21 and pembrolizumab intravenously (IV) over 30 minutes on Day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, every 9 weeks for 18 months, and then every 12 weeks thereafter. PRIMARY OBJECTIVES: Assess 6-month progression free survival (PFS). SECONDARY OBJECTIVES: * To evaluate objective response rate (RR) by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 and immune-related response criteria (irRC). * Evaluate overall survival (OS). * Assess the safety and tolerability of epacadostat in combination with pembrolizumab by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03. TERTIARY OBJECTIVES: * Determine the responder rate defined as the proportion of subjects with an increased ratio of CD8+ to Treg cells in on-treatment compared with pre-treatment biopsies. * Identify putative immunologic biomarkers of tumor response.

Conditions

• Gastric Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma
• Recurrent Esophageal Carcinoma
• Recurrent Gastric Carcinoma
• Stage IV Esophageal Cancer AJCC v7
• Stage IV Gastric Cancer AJCC v7
• Unresectable Esophageal Carcinoma

Interventions

Type	Name	Description
DRUG	Epacadostat	Given PO
DRUG	Pembrolizumab	Given IV

Timeline

• Start date: 2017-09-13
• Primary completion: 2018-05-29
• Completion: 2018-05-29
• First posted: 2017-06-22
• Last updated: 2024-01-23
• Results posted: 2020-06-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study