A Study of Epacadostat in Combination With Pembrolizumab and Chemotherapy in Subjects With Advanced or Metastatic Solid Tumors (ECHO-207/KEYNOTE-723)

  • Interventional
  • Not Recruiting
  • NCT03085914
Eligibility Details Visit Clinicaltrials.gov

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - 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.

        Exclusion Criteria:

         - 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.

At a Glance

National Government IDNCT03085914

IRB#IRB16-1778

Lead SponsorIncyte Corporation

Lead PhysicianDaniel Catenacci

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting