Back to resultsA Study of Epacadostat (INCB024360) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced Solid Tumors (ECHO-203)
Primary Purpose
Solid Tumors, Head and Neck Cancer, Lung Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MEDI4736
INCB024360
Sponsored by
About this trial
This is an interventional treatment trial for Solid Tumors
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects, age 18 years or older
- Histologically or cytologically confirmed diagnosis of selected locally advanced or metastatic solid tumors
- Must have failed at least 1 prior treatment regimen for locally advanced or metastatic disease or be intolerant to treatment or refuse standard treatment
Exclusion Criteria:
- Laboratory and medical history parameters not within protocol-defined range
- Participation in any other study in which receipt of an investigational study drug occurred within 28 days or 5 half-lives (whichever is longer) prior to 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 (exception is tumor types in which a PD-1 pathway targeted agent is approved, e.g. melanoma, non-small cell lung cancer.)
- Receipt of any anticancer medication in the 21 days prior to receiving the first dose of study medication
- Has an active or inactive autoimmune process
- Evidence of interstitial lung disease or active, non-infectious pneumonitis
- Prior radiotherapy within 2 weeks of initiating treatment; 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
- Currently pregnant or breastfeeding
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MEDI4736 + INCB024360
Arm Description
MEDI4736 at selected dose levels every 2 weeks + INCB024360 25 mg BID as starting dose, followed by dose escalations until MTD or PAD is identified
Outcomes
Primary Outcome Measures
Phase 1 : Number of Treatment-Emergent Adverse Events (TEAE)
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
Phase 2: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Secondary Outcome Measures
Phase 1: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified RECIST v1.1
ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Phase 2: Number of Treatment-Emergent Adverse Events
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
Phase 1 and 2: Durability of Response as Measured by the Time From the Earliest Date of Disease Response Until Earliest Date of Disease Progression
Defined as the time from earliest date of disease response until the earliest date of disease progression per RECIST v1.1, or death due to any cause, if occurring sooner than progression.
Phase 1 and 2: Progression-free Survival as Measured by the Duration From the Date of Enrollment Until the Earliest Date of Disease Progression or Death
Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Measured by Peak Concentration
Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Measured by Time to Maximal Observed Concentration
Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Area Under the Concentration-time Curve
Phase 1 and 2: Immunogenicity of MEDI4736 as Measured by the Number and Percentage of Subjects Who Develop Detectable Anti-drug Antibodies (ADAs)
Full Information
NCT ID
NCT02318277
First Posted
November 19, 2014
Last Updated
January 7, 2022
Sponsor
Incyte Corporation
Collaborators
AstraZeneca
1. Study Identification
Unique Protocol Identification Number
NCT02318277
Brief Title
A Study of Epacadostat (INCB024360) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced Solid Tumors (ECHO-203)
Official Title
A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of Epacadostat (INCB024360) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced Solid Tumors (ECHO-203)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 5, 2015 (Actual)
Primary Completion Date
August 28, 2019 (Actual)
Study Completion Date
October 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
Collaborators
AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to explore the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of INCB024360 administered in combination with MEDI4736 in subjects with selected advanced solid tumors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumors, Head and Neck Cancer, Lung Cancer, UC (Urothelial Cancer)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
176 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MEDI4736 + INCB024360
Arm Type
Experimental
Arm Description
MEDI4736 at selected dose levels every 2 weeks + INCB024360 25 mg BID as starting dose, followed by dose escalations until MTD or PAD is identified
Intervention Type
Drug
Intervention Name(s)
MEDI4736
Intervention Description
MEDI4736 administered intravenously (IV) every two weeks (q2w)
Intervention Type
Drug
Intervention Name(s)
INCB024360
Intervention Description
INCB024360: Oral daily dosing
Primary Outcome Measure Information:
Title
Phase 1 : Number of Treatment-Emergent Adverse Events (TEAE)
Description
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
Time Frame
Duration of study treatment and up to 90 days after the last dose [approximately 3 years]
Title
Phase 2: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Description
ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time Frame
Measured every 8 weeks for duration of study treatment [approximately 12 months]
Secondary Outcome Measure Information:
Title
Phase 1: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified RECIST v1.1
Description
ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame
Measured every 8 weeks for duration of study treatment [approximately 6 months]
Title
Phase 2: Number of Treatment-Emergent Adverse Events
Description
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
Time Frame
Continuously for duration of study treatment and up to 90 days after the last dose [approximately 3 years]
Title
Phase 1 and 2: Durability of Response as Measured by the Time From the Earliest Date of Disease Response Until Earliest Date of Disease Progression
Description
Defined as the time from earliest date of disease response until the earliest date of disease progression per RECIST v1.1, or death due to any cause, if occurring sooner than progression.
Time Frame
Measured every 8 weeks for duration of active study treatment [approximately 24 months]
Title
Phase 1 and 2: Progression-free Survival as Measured by the Duration From the Date of Enrollment Until the Earliest Date of Disease Progression or Death
Time Frame
Measured every 8 weeks for duration of active study treatment [approximately 24 months]
Title
Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Measured by Peak Concentration
Time Frame
Pre dose, 0.5, 1,2, 4.6.& 8 hrs Post dose on C1D1,C1D8,C2D1
Title
Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Measured by Time to Maximal Observed Concentration
Time Frame
Pre dose, 0.5, 1,2, 4.6.& 8 hrs Post dose on C1D1,C1D8,C2D1
Title
Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Area Under the Concentration-time Curve
Time Frame
Pre dose, 0.5, 1,2, 4.6.& 8 hrs Post dose on C1D1,C1D8,C2D1
Title
Phase 1 and 2: Immunogenicity of MEDI4736 as Measured by the Number and Percentage of Subjects Who Develop Detectable Anti-drug Antibodies (ADAs)
Time Frame
Measured at defined study visits from Cycle 1 Day 1 through cycle 2 [approximately 2 weeks].
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subjects, age 18 years or older
Histologically or cytologically confirmed diagnosis of selected locally advanced or metastatic solid tumors
Must have failed at least 1 prior treatment regimen for locally advanced or metastatic disease or be intolerant to treatment or refuse standard treatment
Exclusion Criteria:
Laboratory and medical history parameters not within protocol-defined range
Participation in any other study in which receipt of an investigational study drug occurred within 28 days or 5 half-lives (whichever is longer) prior to 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 (exception is tumor types in which a PD-1 pathway targeted agent is approved, e.g. melanoma, non-small cell lung cancer.)
Receipt of any anticancer medication in the 21 days prior to receiving the first dose of study medication
Has an active or inactive autoimmune process
Evidence of interstitial lung disease or active, non-infectious pneumonitis
Prior radiotherapy within 2 weeks of initiating treatment; 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
Currently pregnant or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lance Leopold, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
City
San Francisco
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Port Saint Lucie
State/Province
Florida
Country
United States
City
Sarasota
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Louisville
State/Province
Kentucky
Country
United States
City
Durham
State/Province
North Carolina
Country
United States
City
Huntersville
State/Province
North Carolina
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
36309837
Citation
Naing A, Algazi AP, Falchook GS, Creelan BC, Powderly J, Rosen S, Barve M, Mettu NB, Triozzi PL, Hamm J, Zhou G, Walker C, Dong Z, Patel MR. Phase 1/2 study of epacadostat in combination with durvalumab in patients with metastatic solid tumors. Cancer. 2023 Jan 1;129(1):71-81. doi: 10.1002/cncr.34512. Epub 2022 Oct 30.
Results Reference
derived
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A Study of Epacadostat (INCB024360) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced Solid Tumors (ECHO-203)
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