A Phase 1/2, Open-Label, Safety, Tolerability, and Efficacy Study of Epacadostat in Combination With Pembrolizumab and Chemotherapy in Subjects With Advanced or Metastatic Solid Tumors (ECHO-207/KEYNOTE-723)
This is an open-label, nonrandomized, Phase 1/2 study in subjects with advanced or metastatic
solid tumors. Phase 1 is an assessment to evaluate the safety and tolerability of epacadostat
when given in combination with pembrolizumab and chemotherapy. Once the recommended doses
have been confirmed, subjects with advanced or metastatic CRC, PDAC, NSCLC (squamous or
nonsquamous), UC, SCCHN or any advanced or metastatic solid tumor who progressed on previous
therapy with a PD-1 or PD-L1 inhibitor will be enrolled in Phase 2.
18 Years and up
Accepting Healthy Volunteers?
- Histologically or cytologically confirmed diagnosis of selected advanced or metastatic
- Presence of measurable disease per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Laboratory and medical history parameters not within the Protocol-defined range.
- Receipt of anticancer medications or investigational drugs within the Protocol-defined
intervals before the first administration of study drug.
- Previous radiotherapy within 2 weeks of starting study therapy.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has not recovered to ≤ Grade 1 from toxic effects of previous therapy and/or
complications from previous surgical intervention before starting study therapy.
- Receipt of a live vaccine within 30 days of planned start of study therapy.
- Active infection requiring systemic therapy.
- Subjects who have any active or inactive autoimmune disease or syndrome.
- Women who are pregnant or breastfeeding.