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A Study of Epacadostat in Combination With a PD-1 Inhibitor and Chemotherapy in Subjects With Advanced or Metastatic Solid Tumors (ECHO-207)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2017 by Incyte Corporation
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT03085914
First received: February 28, 2017
Last updated: March 20, 2017
Last verified: March 2017
  Purpose
This is an open-label, nonrandomized, Phase 1/2 study in subjects with advanced or metastatic solid tumors. Phase 1 is a dose-escalation assessment to evaluate the safety and tolerability of epacadostat when given in combination with a PD-1 inhibitor and chemotherapy. Once the recommended doses have been determined, subjects with advanced or metastatic CRC, PDAC, NSCLC (squamous or nonsquamous), 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.

Condition Intervention Phase
Advanced or Metastatic Solid Tumors
Advanced or Metastatic Colorectal Cancer (CRC)
Pancreatic Ductal Adenocarcinoma (PDAC)
Non-Small Cell Lung Cancer (NSCLC; Squamous or Nonsquamous)
Advanced or Metastatic Solid Tumor That Progressed on Previous Therapy With a Programmed Cell Death Protein 1 (PD-1) Inhibitor
Advanced or Metastatic Solid Tumor That Progressed on Previous Therapy With a Programmed Cell Death Ligand 1 (PD-L1) Inhibitor
Drug: Epacadostat
Drug: Nivolumab
Drug: Pembrolizumab
Drug: Oxaliplatin
Drug: Leucovorin
Drug: 5-Fluorouracil
Drug: Gemcitabine
Drug: nab-Paclitaxel
Drug: Carboplatin
Drug: Paclitaxel
Drug: Pemetrexed
Drug: Cyclophosphamide
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open-Label, Dose-Escalation, Safety, Tolerability, and Efficacy Study of Epacadostat in Combination With a PD-1 Inhibitor and Chemotherapy in Subjects With Advanced or Metastatic Solid Tumors (ECHO-207)

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • Phase 1: Safety and tolerability assessed by frequency, duration, and severity of adverse events (AEs) [ Time Frame: Through 90 days after end of treatment, estimated to be up to 15 months per subject ]
    A treatment-emergent AE is defined as an event occurring after exposure to at least 1 dose of study drug. A treatment-related AE is defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE is graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).

  • Phase 2: Objective response rate (ORR) based on modified Response Evaluation Criteria in Solid Tumors (mRECIST) [ Time Frame: Every 8-9 weeks through duration of treatment, estimated to be up to 12 months per subject ]
    Defined as percentage of subjects with a complete response (CR) or partial response (PR)


Secondary Outcome Measures:
  • Phase 1: ORR based on mRECIST [ Time Frame: Every 8-9 weeks through duration of treatment, estimated to be up to 12 months per subject ]
    Defined as percentage of subjects with a CR or PR

  • Phase 2: Safety and tolerability assessed by frequency, duration, and severity of AEs [ Time Frame: Through 90 days after end of treatment, estimated to be up to 15 months per subject ]
    A treatment-emergent AE is defined as an event occurring after exposure to at least 1 dose of study drug. A treatment-related AE is defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE is graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).

  • Phases 1 and 2: Duration of response (DOR) [ Time Frame: Every 8-9 weeks through duration of treatment, estimated to be up to 12 months per subject ]
    DOR defined as time from earliest date of CR or PR until the earliest date of disease progression or death due to any cause, if occurring sooner than disease progression.

  • Phases 1 and 2: Progression-free survival [ Time Frame: Every 8-9 weeks through duration of treatment, estimated to be up to 12 months per subject ]
    Defined as time from date of first dose of study medication until the earliest date of disease progression or death due to any cause, if occurring sooner than progression.


Estimated Enrollment: 332
Anticipated Study Start Date: April 2017
Estimated Study Completion Date: October 2022
Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Group A
Epacadostat + nivolumab + mFOLFOX6 (oxaliplatin, leucovorin, 5-fluorouracil)
Drug: Epacadostat
Epacadostat oral twice-daily continuous daily dosing at the protocol-defined dose
Other Name: INCB024360
Drug: Nivolumab
Nivolumab 240 mg IV on Days 1 and 15
Drug: Oxaliplatin
Oxaliplatin 85 mg/m^2 IV on Days 1 and 15
Drug: Leucovorin
Leucovorin 400 mg/m^2 IV on Days 1 and 15
Drug: 5-Fluorouracil
5-Fluorouracil total dose of 2400 mg/m^2 on Days 1 and 15
Experimental: Treatment Group B
Epacadostat + nivolumab + gemcitabine and nab-paclitaxel
Drug: Epacadostat
Epacadostat oral twice-daily continuous daily dosing at the protocol-defined dose
Other Name: INCB024360
Drug: Nivolumab
Nivolumab 240 mg IV on Days 1 and 15
Drug: Gemcitabine
Gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15
Drug: nab-Paclitaxel
nab-Paclitaxel 125 mg/m^2 IV on Days 1, 8, and 15
Experimental: Treatment Group C
Epacadostat + pembrolizumab + carboplatin and paclitaxel
Drug: Epacadostat
Epacadostat oral twice-daily continuous daily dosing at the protocol-defined dose
Other Name: INCB024360
Drug: Pembrolizumab
Pembrolizumab 200 mg IV every 3 weeks
Drug: Carboplatin
Carboplatin AUC 6 IV on Day 1 every 3 weeks
Drug: Paclitaxel
Paclitaxel 200 mg/m^2 IV on Day 1 every 3 weeks
Experimental: Treatment Group D
Epacadostat + pembrolizumab + carboplatin and pemetrexed
Drug: Epacadostat
Epacadostat oral twice-daily continuous daily dosing at the protocol-defined dose
Other Name: INCB024360
Drug: Pembrolizumab
Pembrolizumab 200 mg IV every 3 weeks
Drug: Pemetrexed
Pemetrexed 500 mg/m^2 IV on Day 1 every 3 weeks
Drug: Carboplatin
Carboplatin AUC 5 IV on Day 1 every 3 weeks
Experimental: Treatment Group E
Epacadostat + pembrolizumab + cyclophosphamide
Drug: Epacadostat
Epacadostat oral twice-daily continuous daily dosing at the protocol-defined dose
Other Name: INCB024360
Drug: Pembrolizumab
Pembrolizumab 200 mg IV every 3 weeks
Drug: Cyclophosphamide
Cyclophosphamide 50 mg orally once daily

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03085914

Contacts
Contact: Incyte Corporation Call Center 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 globalmedinfo@incyte.com

Locations
United States, Arizona
Mayo Clinic Arizona Not yet recruiting
Phoenix, Arizona, United States, 85259
United States, California
University of California San Diego Medical Center, Moores Cancer Center Not yet recruiting
La Jolla, California, United States, 92093
United States, Illinois
University of Chicago Not yet recruiting
Chicago, Illinois, United States, 60637
United States, New York
Memorial Sloan Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10065
United States, North Carolina
Carolina Bio-Oncology Institute, PLLC Not yet recruiting
Huntersville, North Carolina, United States, 28078
United States, Oregon
Oregon Health & Science University Not yet recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pennsylvania Health System Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Cancer Institute Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15237
United States, Tennessee
Vanderbilt Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Institute at University of Utah Not yet recruiting
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Hiroomi Tada, MD, PhD Incyte Corporation
  More Information

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03085914     History of Changes
Other Study ID Numbers: 24360-207 / ECHO-207
Study First Received: February 28, 2017
Last Updated: March 20, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Incyte Corporation:
solid tumors
colorectal cancer
pancreatic ductal adenocarcinoma
non-small cell lung cancer
PD-1
PD-L1
epacadostat
IDO inhibitor

Additional relevant MeSH terms:
Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Adenocarcinoma
Death
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pathologic Processes
Gemcitabine
Fluorouracil
Pemetrexed
Cyclophosphamide
Oxaliplatin

ClinicalTrials.gov processed this record on April 26, 2017