for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion



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.

Official Title

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)


Solid TumorsColorectal Cancer (CRC)Adenocarcinoma (PDAC)Lung CancerUC (Urothelial Cancer)Head and Neck Cancercolorectal cancerpancreatic ductal adenocarcinomanon-small cell lung cancerPD-1PD-L1epacadostatIDO inhibitorColorectal NeoplasmsAdenocarcinomaHead and Neck NeoplasmsPaclitaxelAlbumin-Bound PaclitaxelCisplatinGemcitabineCyclophosphamideCarboplatinOxaliplatinPembrolizumabFluorouracilPemetrexedLeucovorin5-Fluorouracilnab-Paclitaxel


You can join if…

Open to people ages 18 years and up

  • Histologically or cytologically confirmed diagnosis of selected advanced or metastatic solid tumors.
  • Presence of measurable disease per RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

You CAN'T join if...

  • 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.


  • University of California San Diego Medical Center, Moores Cancer Center
    La JollaCalifornia92093United States
  • The Angeles Clinic and Research Institute
    Los AngelesCalifornia90025United States


in progress, not accepting new patients
Start Date
Completion Date
Incyte Corporation
Phase 1/2
Study Type
Last Updated