This is a Phase 1/2, open label study that will be conducted in 2 parts. The first part of the study (Phase 1) will consist of a dose-escalation assessment of the safety and tolerability of epacadostat administered with nivolumab in subjects with select advanced solid tumors and lymphomas including melanoma (MEL), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), head and neck squamous cell carcinoma (SCCHN), ovarian cancer, and B cell non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL). The second part (Phase 2) of the study will include expansion cohorts in the tumor types tested in Phase 1 (except diffuse large B-cell lymphoma (DLBCL) will be the only lymphoma permitted and Phase 2 will also include a cohort for glioblastoma) with a) historically good activity with nivolumab monotherapy, and b) with historically low activity with nivolumab monotherapy.
A Phase 1/2 Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)
Melanoma Carcinoma, Non-Small-Cell Lung Colorectal Neoplasms Carcinoma, Squamous Cell of Head and Neck Ovarian Neoplasms B Cell NHL Including DLBCL HL Glioblastoma Nivolumab Antibodies, Monoclonal
Open to people ages 18 years and up
Metastatic or recurrent squamous cell carcinoma not amenable to local therapy with curative intent (surgery or radiation with or without chemotherapy)
-Histologically confirmed recurrent or metastatic carcinoma of the nasopharynx and salivary gland or non-squamous histologies will be excluded
Subjects who have received prior immune checkpoint inhibitors (eg, anti-CTLA-4,anti-PD-1, anti-PD-L1, and any other antibody or drug specifically targeting T-cell costimulation) or an IDO inhibitor. Subjects who have received experimental vaccines or other immune therapies should be discussed with the medical monitor to confirm eligibility
o Anti-CTLA-4 given as first-line treatment for metastatic MEL will be permitted
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
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