Summary

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

Description

Summary

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)

Keywords

Solid Tumors Colorectal Cancer (CRC) Adenocarcinoma (PDAC) Lung Cancer UC (Urothelial Cancer) Head and Neck Cancer colorectal cancer pancreatic ductal adenocarcinoma non-small cell lung cancer PD-1 PD-L1 epacadostat IDO inhibitor Colorectal Neoplasms Adenocarcinoma Head and Neck Neoplasms Paclitaxel Gemcitabine Oxaliplatin Pembrolizumab Albumin-Bound Paclitaxel Cisplatin Cyclophosphamide Carboplatin Fluorouracil Pemetrexed Leucovorin 5-Fluorouracil nab-Paclitaxel

Eligibility

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.

Locations

  • University of California San Diego Medical Center, Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • The Angeles Clinic and Research Institute accepting new patients
    Los Angeles California 90025 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
ID
NCT03085914
Phase
Phase 1/2
Study Type
Interventional
Last Updated