Trial ID # | NCT02178722 |
Phase | II |
Drug Class | Immunotherapy: Checkpoint Inhibitors/PD-1 |
Drug Name | Pembrolizumab |
Alternate Drug Names | Keytruda, Lambrolizumab, SCH 900475, MK3475, MK-3475 |
Drugs in Trial | Epacadostat, Pembrolizumab |
Eligible Participant | Recurrent or persistent cancer |
Patients Enrolled | 463 (Phase II: 37 ovarian; median ≥3 prior therapies) |
Therapy Setting | Recurrence |
Study Design | Open-Label, Non-randomized |
Endpoints | ORR, DCR, evaluated per RECIST |
Biomarkers | Exploratory: PD-L1 protein |
Efficacy | ORR: 8% (3PR, n=37) Exploratory analysis PD-L1+ patients: |
Clinically Significant Adverse Events | Serious AE: none |
Conclusion | Encouraging anti-tumor activity with acceptable safety profile |
Reference | Spira AI et al. Efficacy/Safety of Epacadostat Plus Pembrolizumab in Triple-Negative Breast Cancer and Ovarian Cancer: Phase 1/2 ECHO-202 Study. J Clin Oncol (2017) 35 (suppl; abstr 1103) |