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A Study of Epacadostat (INCB024360) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced Solid Tumors (ECHO-203)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02318277
Recruitment Status : Completed
First Posted : December 17, 2014
Results First Posted : December 29, 2020
Last Update Posted : January 13, 2022
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Incyte Corporation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Solid Tumors Head and Neck Cancer Lung Cancer UC (Urothelial Cancer) Drug: MEDI4736 Drug: INCB024360 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 5, 2015
Actual Primary Completion Date : August 28, 2019
Actual Study Completion Date : October 16, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: MEDI4736 + INCB024360
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
 Drug: MEDI4736
MEDI4736 administered intravenously (IV) every two weeks (q2w)

Drug: INCB024360
INCB024360: Oral daily dosing


Outcome Measures
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Primary Outcome Measures :
  1. Phase 1 : Number of Treatment-Emergent Adverse Events (TEAE) [ Time Frame: Duration of study treatment and up to 90 days after the last dose [approximately 3 years] ]
    Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment

  2. Phase 2: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Measured every 8 weeks for duration of study treatment [approximately 12 months] ]
    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 :
  1. Phase 1: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified RECIST v1.1 [ Time Frame: Measured every 8 weeks for duration of study treatment [approximately 6 months] ]
    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

  2. Phase 2: Number of Treatment-Emergent Adverse Events [ Time Frame: Continuously for duration of study treatment and up to 90 days after the last dose [approximately 3 years] ]
    Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment

  3. 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 [ Time Frame: Measured every 8 weeks for duration of active study treatment [approximately 24 months] ]
    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.

  4. 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] ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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]. ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02318277


Locations
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United States, California
San Francisco, California, United States
United States, Colorado
Denver, Colorado, United States
United States, Florida
Miami, Florida, United States
Port Saint Lucie, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, North Carolina
Durham, North Carolina, United States
Huntersville, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
Sponsors and Collaborators
Incyte Corporation
AstraZeneca
Investigators
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Study Director: Lance Leopold, MD Incyte Corporation
  Study Documents (Full-Text)

Documents provided by Incyte Corporation:
Study Protocol  [PDF] September 21, 2018
Statistical Analysis Plan  [PDF] November 26, 2014

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02318277    
Other Study ID Numbers: INCB 24360-203 / ECHO-203
First Posted: December 17, 2014    Key Record Dates
Results First Posted: December 29, 2020
Last Update Posted: January 13, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
 Durvalumab
Antineoplastic Agents, Immunological
Antineoplastic Agents