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CompletedNCT02318277Updated Jan 13, 2022Results posted

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

A Phase 1/2 interventional study of MEDI4736 and INCB024360 in Solid Tumors, Head and Neck Cancer and Lung Cancer, sponsored by Incyte Corporation. Completed at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-13.

Sponsored by Incyte Corporation · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
176
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Solid Tumors
  • Head and Neck Cancer
  • Lung Cancer
  • UC (Urothelial Cancer)
03

In context

Head and Neck Neoplasms

2,403 studies on the registry are indexed under Head and Neck Neoplasms; 559 are open to participants now.

This study's enrollment of 176 is above the median of 47 across 1,791 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Incyte Corporation is the lead sponsor of 288 studies on the registry; 35 are open to participants now.

Of its 148 completed or terminated interventional studies of FDA-regulated products, 94 (64%) have results posted.

Browse Incyte Corporation studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
176 participants (actual)

Study arms

  • 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 · Drug: INCB024360

Interventions

  • DrugMEDI4736

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

  • DrugINCB024360

    INCB024360: Oral daily dosing

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Duration of study treatment and up to 90 days after the last dose [approximately 3 years]

  2. 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.

    Time frame: Measured every 8 weeks for duration of study treatment [approximately 12 months]

Secondary outcomes

  1. 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

    Time frame: Measured every 8 weeks for duration of study treatment [approximately 6 months]

  2. 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

    Time frame: Continuously for duration of study treatment and up to 90 days after the last dose [approximately 3 years]

  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

    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]

  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].

07

Results

Posted Dec 29, 2020

Participant flow

This study was conducted at 13 study sites in the United States. Participants were enrolled at 12 study sites.

Participant flow — Overall Study
MilestonePhase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Started6344894993
Completed00000000
Not completed6344894993
Withdrew: Physician decision00000001
Withdrew: Other00000010
Withdrew: Withdrawal by subject001011614
Withdrew: Participant trial terminated by sponsor001012516
Withdrew: Lost to follow-up10100034
Withdrew: Death5314653458
Withdrew: Transitioned to hospice00000100

Outcome measures

PrimaryPhase 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

Time frame:
Duration of study treatment and up to 90 days after the last dose [approximately 3 years]
Reported as:
Count of participants · Participants
Phase 1 : Number of Treatment-Emergent Adverse Events (TEAE)
ParticipantsPhase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Phase 1 : Number of Treatment-Emergent Adverse Events (TEAE)634489
PrimaryPhase 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.

Time frame:
Measured every 8 weeks for duration of study treatment [approximately 12 months]
Reported as:
Count of participants · Participants
Phase 2: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
ParticipantsPhase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Phase 2: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1612
SecondaryPhase 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

Time frame:
Measured every 8 weeks for duration of study treatment [approximately 6 months]
Reported as:
Count of participants · Participants
Phase 1: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified RECIST v1.1
ParticipantsPhase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Phase 1: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified RECIST v1.1101012
SecondaryPhase 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

Time frame:
Continuously for duration of study treatment and up to 90 days after the last dose [approximately 3 years]
Reported as:
Count of participants · Participants
Phase 2: Number of Treatment-Emergent Adverse Events
ParticipantsPhase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Phase 2: Number of Treatment-Emergent Adverse Events4993
SecondaryPhase 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.

Time frame:
Measured every 8 weeks for duration of active study treatment [approximately 24 months]
Reported as:
Median · months
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
monthsPhase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Phase 1 and 2: Durability of Response as Measured by the Time From the Earliest Date of Disease Response Until Earliest Date of Disease Progression1.9 (NA to NA)—NA (NA to NA)—NA (NA to NA)NA (25.6 to NA)13.8 (8.5 to NA)NA (1.9 to NA)
SecondaryPhase 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]
Reported as:
Median · Months
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
MonthsPhase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
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 Death2.4 (1.3 to 7.3)12.0 (1.8 to NA)1.9 (1.1 to NA)1.7 (0.5 to 5.9)4.1 (0.7 to NA)2.5 (1.1 to 27.2)1.9 (1.7 to 2.3)2.1 (1.9 to 3.7)
SecondaryPhase 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
Reported as:
Mean · nM
Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Measured by Peak Concentration
nMPhase I : Epacadostat (25 mg) + DurvalumabPhase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Measured by Peak Concentration273 ± 65.3248 ± 135604 ± 493727 ± 4032660 ± 1200960 ± 4992500 ± 1190
SecondaryPhase 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
Reported as:
Median · hours
Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Measured by Time to Maximal Observed Concentration
hoursPhase I : Epacadostat (25 mg) + DurvalumabPhase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Measured by Time to Maximal Observed Concentration2.0 (1.0 to 2.2)2.0 (1.0 to 3.8)1.9 (0.017 to 3.9)2.0 (0.92 to 6.0)3.3 (1.2 to 6.0)2.0 (0.0 to 5.7)2.1 (0.52 to 5.5)
SecondaryPhase 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
Reported as:
Mean · h*nM
Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Area Under the Concentration-time Curve
h*nMPhase I : Epacadostat (25 mg) + DurvalumabPhase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Area Under the Concentration-time Curve1040 ± 3451580 ± 7393090 ± 18803650 ± 271015400 ± 67704130 ± 196012200 ± 5950
SecondaryPhase 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].
Reported as:
Count of participants · Participants
Phase 1 and 2: Immunogenicity of MEDI4736 as Measured by the Number and Percentage of Subjects Who Develop Detectable Anti-drug Antibodies (ADAs)
ParticipantsPhase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)EditPhase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)EditPhase 2 Stage 1: Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase 2 Stage 2: Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Phase 1 and 2: Immunogenicity of MEDI4736 as Measured by the Number and Percentage of Subjects Who Develop Detectable Anti-drug Antibodies (ADAs)00000100

Adverse events

Collected over Duration of study treatment and up to 90 days after the last dose [approximately 3 years]. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Phase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)5/6 (83.3%)2/6 (33.3%)6/6 (100%)
Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)3/3 (100%)0/3 (0%)3/3 (100%)
Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)1/4 (25%)2/4 (50%)4/4 (100%)
Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)4/4 (100%)0/4 (0%)4/4 (100%)
Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)6/8 (75%)4/8 (50%)8/8 (100%)
Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)5/9 (55.6%)3/9 (33.3%)9/9 (100%)
Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)35/49 (71.4%)20/49 (40.8%)48/49 (98%)
Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)58/93 (62.4%)54/93 (58.1%)87/93 (93.5%)
Most frequent serious events
Showing 10 of 105
Most frequent serious events
EventPhase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Abdominal painGastrointestinal disorders0/60/30/40/42/80/93/491/93
BacteraemiaInfections and infestations0/60/31/40/40/80/90/491/93
FallInjury, poisoning and procedural complications0/60/31/40/40/80/90/490/93
HyponatraemiaMetabolism and nutrition disorders0/60/31/40/40/80/90/491/93
HypotensionVascular disorders0/60/31/40/40/80/90/494/93
PyrexiaGeneral disorders0/60/31/40/40/80/91/493/93
Subarachnoid haemorrhageNervous system disorders0/60/31/40/40/80/90/490/93
AnaemiaBlood and lymphatic system disorders1/60/30/40/40/80/92/494/93
DyspnoeaRespiratory, thoracic and mediastinal disorders1/60/30/40/41/80/95/494/93
Pleural effusionRespiratory, thoracic and mediastinal disorders1/60/30/40/40/80/90/492/93
Most frequent other events
Showing 10 of 153
Most frequent other events
EventPhase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
CoughRespiratory, thoracic and mediastinal disorders2/62/31/42/41/82/97/4919/93
FatigueGeneral disorders4/61/32/42/43/82/925/4950/93
NauseaGastrointestinal disorders4/61/31/41/44/83/913/4928/93
ConstipationGastrointestinal disorders1/61/32/40/42/81/911/4920/93
HeadacheNervous system disorders0/60/32/40/41/81/96/4916/93
PyrexiaGeneral disorders0/60/32/40/43/81/911/4910/93
Abdominal pain upperGastrointestinal disorders0/60/30/40/43/80/91/492/93
Oedema peripheralGeneral disorders0/61/30/40/43/80/95/499/93
VomitingGastrointestinal disorders0/60/31/40/43/83/97/4917/93
Abdominal painGastrointestinal disorders1/61/30/41/41/82/95/4910/93

Baseline characteristics

Intent-to-Treat Population who are enrolled in Phase 1 and 2 part of the study

Age, Continuous
Age, Continuous(Years)Phase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)Total
Mean70.8 ± 4.7975.7 ± 7.2365.3 ± 9.0772.3 ± 7.5958.6 ± 8.6563.4 ± 7.7560.2 ± 13.2464 ± 10.2763.3 ± 11.11
Sex: Female, Male
Sex: Female, Male(Participants)Phase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)Total
Female321115192557
Male3133743068119
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Phase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)Total
White6344794183157
Black or African American0000105511
Asian000000134
Other000000123
Missing000000101
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Phase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)Total
Hispanic or Latino200100137
Not Hispanic or Latino4343894687164
Not Reported000000011
Unknown000000224
08

Study locations

13 sites
  • San Francisco, California, United States
  • Denver, Colorado, United States
  • Miami, Florida, United States
  • Port Saint Lucie, Florida, United States
  • Sarasota, Florida, United States
  • Tampa, Florida, United States
  • Chicago, Illinois, United States
  • Louisville, Kentucky, United States
  • Durham, North Carolina, United States
  • Huntersville, North Carolina, United States
  • Winston-Salem, North Carolina, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
09

References and documents

Publications

  • 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. PubMed 36309837 ↗

Study documents

  • Study protocol · Sep 21, 2018
  • Statistical analysis plan · Nov 26, 2014

Documents are hosted by the registry — open the source record to download them.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2015 to primary completion in Aug 2019, 55 months.

Results were first posted in Dec 2020, 1 year 4 months after primary completion.

Of 42 industry-sponsored phase 1/2 interventional studies under Head and Neck Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 44 and three quarters within 84. This study's 55 months is close to that.

Counting every sponsor, half of 78 studies reached it within 55 months; a quarter within 36 and three quarters within 84.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 19, 2014
First posted
Dec 17, 2014
StartActual
Jan 5, 2015
Primary completionActual
Aug 28, 2019
CompletionActual
Oct 16, 2020
Results first posted
Dec 29, 2020
Last update
Jan 13, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02318277
Lead sponsor
Incyte Corporation
Collaborators
AstraZeneca
Responsible party
Sponsor
First posted
Dec 17, 2014
Start date
Jan 5, 2015
Primary completion
Aug 28, 2019
Completion
Oct 16, 2020
Results posted
Dec 29, 2020
Last update
Jan 13, 2022

Study contacts

Lance Leopold, MD
study director · Incyte Corporation

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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