A Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies (ECHO-208)

• Status: Completed
• Trial end date: 2021-01-29
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety, tolerability, and efficacy of epacadostat when given in combination with nivolumab and ipilimumab, and in combination with nivolumab and lirilumab, in subjects with advanced or metastatic malignancies.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Treatments: Antibodies, Monoclonal; Ipilimumab; Nivolumab

Criteria

Inclusion Criteria:

• During Phase 1, subjects with locally advanced or metastatic solid tumors with disease progression on or after treatment with available therapies, or who are intolerant to treatment, or who refuse standard treatment.

• During Phase 2, subjects with advanced cancer who have received at least one prior therapy or are treatment naive, depending on the specified tumor type.

• Presence of measurable disease per RECIST v1.1.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Expected survival of ≥ 12 weeks.

Exclusion Criteria:

• Laboratory and medical history parameters not within the Protocol-defined range.

• Receipt of anticancer medications or investigational drugs within Protocol-defined time frames.

• Previous radiotherapy within 7 days of Cycle 1 Day 1.

• Known active central nervous system metastases and/or carcinomatous meningitis.

• Prior treatment with any immune checkpoint inhibitor and/or an IDO inhibitor.

• Active infection requiring systemic therapy.

• Any active or inactive autoimmune disease or syndrome