Clinical trial · Interventional
A Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Participants With Advanced or Metastatic Malignancies (ECHO-208)
A Phase 1/2, Open-Label, Dose-Escalation, Safety, Tolerability, and Efficacy Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies (ECHO-208)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): A business decision made by Incyte after analysis of data from a sister study.
Summary
Brief summary (as posted)
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 participant with advanced or metastatic malignancies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epacadostat | Drug | — | UNRESOLVED |
| Ipilimumab | Drug | Ipilimumab | ALIAS |
| Lirilumab | Drug | — | UNRESOLVED |
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- Phase 1: Dose Escalation: Treatment Group A: Cohort 1 Epacadostat 50 mg BID
- description
- Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 50 mg BID orally in combination with nivolumab 240 mg on day 1 of each 14 day cycle and ipilimumab 1 mg/kg intravenous (IV) every 6 weeks thereafter on Day 1 of every third treatment cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
- interventionNames
- Drug: Epacadostat
- Drug: Nivolumab
- Drug: Ipilimumab
- type
- EXPERIMENTAL
- label
- Phase 1: Dose Escalation: Treatment Group A: Cohort 2 Epacadostat 100 mg BID
- description
- Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 100 mg BID orally in combination with nivolumab 240 mg on day 1 of each 14 day cycle and ipilimumab 1 mg/kg intravenous (IV) every 6 weeks thereafter on Day 1 of every third treatment cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * During Phase 1, participant 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, participant 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
References
Publications (0)
Data not yet available