Clinical trial NCT02318277: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Solid Tumors
Head and Neck Cancer
Lung Cancer
UC (Urothelial Cancer)
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2014-12-17
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Phase 1 : Number of Treatment-Emergent Adverse Events (TEAE)
timeFrame: Duration of study treatment and up to 90 days after the last dose [approximately 3 years]
measure: Phase 2: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
timeFrame: Measured every 8 weeks for duration of study treatment [approximately 12 months]
Secondary outcomes:
measure: Phase 1: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified RECIST v1.1
timeFrame: Measured every 8 weeks for duration of study treatment [approximately 6 months]
measure: Phase 2: Number of Treatment-Emergent Adverse Events
timeFrame: Continuously for duration of study treatment and up to 90 days after the last dose [approximately 3 years]
measure: 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
timeFrame: Measured every 8 weeks for duration of active study treatment [approximately 24 months]
measure: 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
timeFrame: Measured every 8 weeks for duration of active study treatment [approximately 24 months]
measure: Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Measured by Peak Concentration
timeFrame: Pre dose, 0.5, 1,2, 4.6.& 8 hrs Post dose on C1D1,C1D8,C2D1
measure: Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Measured by Time to Maximal Observed Concentration
timeFrame: Pre dose, 0.5, 1,2, 4.6.& 8 hrs Post dose on C1D1,C1D8,C2D1
measure: Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Area Under the Concentration-time Curve
timeFrame: Pre dose, 0.5, 1,2, 4.6.& 8 hrs Post dose on C1D1,C1D8,C2D1
measure: Phase 1 and 2: Immunogenicity of MEDI4736 as Measured by the Number and Percentage of Subjects Who Develop Detectable Anti-drug Antibodies (ADAs)
timeFrame: Measured at defined study visits from Cycle 1 Day 1 through cycle 2 [approximately 2 weeks].
Other outcomes:
Locations:
city: San Francisco
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Miami
country: United States
state: Florida
city: Port Saint Lucie
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Louisville
country: United States
state: Kentucky
city: Durham
country: United States
state: North Carolina
city: Huntersville
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
Study officials:
affiliation: Incyte Corporation
name: Lance Leopold, MD
role: STUDY_DIRECTOR
References:
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.