NCT02298153

Brief Summary

This study evaluated the safety and tolerability of epacadostat (INCB024360) administered in combination with atezolizumab (MPDL3280A) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that were previously treated with platinum-based chemotherapy and Stage IV urothelial carcinoma who failed a platinum-based chemotherapy regimen. The study was conducted in two phases. The dose escalation phase did utilize a 3 + 3 design to identify the maximum tolerated dose (MTD) or a Pharmacologically Active Dose (PAD) of the combination. This was followed by a dose expansion phase, which was comprised of three cohorts. Expansion Cohorts 1 \& 2 will further evaluate the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics at the dose identified in phase one. Expansion Cohort 3 will evaluate the change in biomarker expression following treatment with epacadostat as monotherapy followed by epacadostat and atezolizumab administered in combination.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2015

Typical duration for phase_1

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

January 27, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2017

Completed
Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

October 31, 2014

Last Update Submit

April 15, 2026

Conditions

NSCLC (Non-small Cell Lung Carcinoma)UC (Urothelial Cancer)

Outcome Measures

Primary Outcomes (2)

  • Incidence of adverse events (AEs)

    Continuously for duration of study participation and up to 42 days after the last dose [approximately 8 months

  • Incidence of dose-limiting toxicities (DLTs)

    21 days following the first administration of atezolizumab and epacadostat

Secondary Outcomes (4)

  • Objective response rate (ORR)

    Measured every 6 weeks for duration of study participation [approximately 8 months]

  • Durability of response

    Measured every 6 weeks for duration of study participation [approximately 8 months]

  • Progression-free survival

    Measured every 6 weeks for duration of study participation [approximately 8 months]

  • Duration of disease control

    Measured every 6 weeks for duration of study participation [approximately 8 months]

Study Arms (6)

Epacadostat 25 mg+Atezolizumab 1200 mg

EXPERIMENTAL

Epacadostat 25 mg tablet orally twice daily (BID) starting on Cycle 1 Day 1 in combination with atezolizumab 1200 mg administered intravenously every 3 weeks starting on Cycle 1 Day 1.

Drug: EpacadostatDrug: Atezolizumab

Epacadostat 50 mg+Atezolizumab 1200 mg

EXPERIMENTAL

Epacadostat 50 mg tablet orally BID starting on Cycle 1 Day 1 in combination with atezolizumab 1200 mg administered intravenously every 3 weeks starting on Cycle 1 Day 1.

Drug: EpacadostatDrug: Atezolizumab

Epacadostat 75 mg+Atezolizumab 1200 mg

EXPERIMENTAL

Epacadostat 75 mg tablet orally BID starting on Cycle 1 Day 1 in combination with atezolizumab 1200 mg administered intravenously every 3 weeks starting on Cycle 1 Day 1.

Drug: EpacadostatDrug: Atezolizumab

Epacadostat 100 mg+Atezolizumab 1200 mg

EXPERIMENTAL

Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with atezolizumab 1200 mg administered intravenously every 3 weeks starting on Cycle 1 Day 1.

Drug: EpacadostatDrug: Atezolizumab

Epacadostat 200 mg+Atezolizumab 1200 mg

EXPERIMENTAL

Epacadostat 200 mg tablet orally BID starting on Cycle 1 Day 1 in combination with atezolizumab 1200 mg administered intravenously every 3 weeks starting on Cycle 1 Day 1.

Drug: EpacadostatDrug: Atezolizumab

Epacadostat 300 mg+Atezolizumab 1200 mg

EXPERIMENTAL

Epacadostat 300 mg tablet orally BID starting on Cycle 1 Day 1 in combination with atezolizumab 1200 mg administered intravenously every 3 weeks starting on Cycle 1 Day 1.

Drug: EpacadostatDrug: Atezolizumab

Interventions

AtezolizumabDRUG

Atezolizumab intravenously

Also known as: MPDL3280A
Epacadostat 100 mg+Atezolizumab 1200 mgEpacadostat 200 mg+Atezolizumab 1200 mgEpacadostat 25 mg+Atezolizumab 1200 mgEpacadostat 300 mg+Atezolizumab 1200 mgEpacadostat 50 mg+Atezolizumab 1200 mgEpacadostat 75 mg+Atezolizumab 1200 mg
EpacadostatDRUG

Epacadostat tablets

Also known as: INCB024360
Epacadostat 100 mg+Atezolizumab 1200 mgEpacadostat 200 mg+Atezolizumab 1200 mgEpacadostat 25 mg+Atezolizumab 1200 mgEpacadostat 300 mg+Atezolizumab 1200 mgEpacadostat 50 mg+Atezolizumab 1200 mgEpacadostat 75 mg+Atezolizumab 1200 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects, age 18 years or older
  • Histologically or cytologically confirmed NSCLC
  • Stage IIIB or Stage IV NSCLC who are not candidates for multimodality treatment and have received at least 1 line of standard platinum-based therapy:
  • Prior systemic regimens must include at least 2 cycles of a platinum-based therapy and may include platinum therapy used as a radiosensitizer. Maintenance chemotherapy is allowed.
  • Tumors with driver mutations (epidermal growth factor receptor mutation positive or anaplastic lymphoma kinase fusion oncogene positive) should have had disease progression or been intolerant to the standard tyrosine-kinase inhibitor (TKI), and should include a second line TKI where such therapy is available and indicated.
  • Subjects initially treated with a platinum regimen for Stage IIIB disease who later develop metastatic disease and are re-treated with a platinum regimen are allowed.
  • Histologically or cytologically confirmed urothelial carcinoma.
  • Stage IV locally advanced or metastatic urothelial carcinoma with disease progression during or following platinum-containing chemotherapy or had disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
  • Presence of measurable disease per RECIST v1.1
  • Availability of an adequate archival tumor specimen or willingness to undergo a pretreatment tumor biopsy.
  • Subjects enrolled in Expansion Cohort 3 must be willing to have 2 on-treatment tumor biopsies.
  • For males and females of child-bearing potential, willingness to use adequate birth control through 90 days after the last dose of epacadostat or atezolizumab.

You may not qualify if:

  • Laboratory and medical history parameters not within protocol-defined range.
  • Current treatment with an investigational study drug or immunological-based agent for any reason, or receipt of anticancer medication within 21 days or 5 half-lives (whichever is longer) before first dose.
  • Prior treatment with immune checkpoint inhibitors (eg, anti-CTLA-4, anti-PD-1, anti-PD-L1, and any other antibody or drug specifically targeting T-cell co-stimulation) or an IDO inhibitor.
  • Prior monoclonal antibody within 4 weeks before study Day 1, or has not recovered from adverse events due to agents administered more than 4 weeks earlier.
  • Has an active or inactive autoimmune process.
  • Has a history of pneumonitis or idiopathic pulmonary fibrosis, or evidence of interstitial lung disease.
  • Prior radiotherapy within 2 weeks of therapy; Must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
  • Untreated central nervous system (CNS) metastases or CNS metastases that have progressed after completion of radiotherapy.
  • Use of systemic corticosteroids ≤ 2 weeks before Cycle 1 Day 1.
  • Currently pregnant or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Pinnacle Oncology Hematology

Scottsdale, Arizona, 85258, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Harvard-Mass General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

University of Washington

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

epacadostatatezolizumab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Hiroomi Tada, MD

    Incyte Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2014

First Posted

November 21, 2014

Study Start

January 27, 2015

Primary Completion

November 8, 2017

Study Completion

November 8, 2017

Last Updated

April 20, 2026

Record last verified: 2026-04

Locations

US(6)