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Completed

NCT Number: NCT02318277

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

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.

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Key information

Conditions

Solid Tumors Head and Neck Cancer Head and Neck Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms UC (Urothelial Cancer)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

San Francisco, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MEDI4736

Drug

MEDI4736 administered intravenously (IV) every two weeks (q2w)

INCB024360

Drug

INCB024360: Oral daily dosing

Primary outcomes

  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 outcomes

  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].

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Collaborators

  • AstraZeneca

Registry information

Official study 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)

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Dec 17, 2014
Registry last updated
Jan 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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