At a glance
ClinicalIndex Comparison Record- ✓Part A: Histologically-confirmed metastatic or locally advanced solid tumor refractory to, progressive on, or without standard therapy
- ✓Part B: Histologically or cytologically confirmed NSCLC stage IIIB/IV, treatment-naïve, confirmed EGFR/ALK wild-type status
- ✓Part B Cohorts 1 & 2: Non-squamous histology only
- ✓At least one measurable lesion by CT/MRI per RECIST 1.1
- ✕Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4, or IDO1 inhibitors
- ✕Active CNS metastases or carcinomatous meningitis
- ✕Symptomatic ascites or pleural effusion
- ✕Active autoimmune disease requiring systemic treatment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I Study of INCB024360 (Epacadostat) Alone, INCB024360 in Combination With Pembrolizumab (MK-3475), and INCB024360 and Pembrolizumab in Combination With Chemotherapy in Patients With Advanced Solid Tumors (KEYNOTE-434)
In Brief
A Phase 1 clinical trial evaluating Epacadostat 25 mg, Epacadostat 100 mg, and 6 other interventions for Neoplasms and Carcinoma, Non-Small-Cell Lung. Completed, enrolled 34 participants.
Detailed Summary
This is an open-label, non-randomized, Phase I study of epacadostat (INCB024360) alone and in combination with pembrolizumab with chemotherapy and pembrolizumab without chemotherapy in participants with advanced solid tumors. The primary objective of the trial is to evaluate the safety and tolerability of epacadostat administered alone and in combination with pembrolizumab with and without chemotherapy. With protocol amendment 02 (26-April-2019), treatment with epacadostat was stopped in the "Epacad+Pembro+Cisplatin+Pemetrexed", "Epacad+Pembro+Carboplatin+Pemetrexed", and "Epacad+Pembro+Carboplatin+Paclitaxel" study arms.
Study Details
Timeline
Interventions
Oral administration
Oral administration
Intravenous (IV) infusion
IV infusion
IV infusion
IV infusion
IV infusion
IV infusion