Solid TumorsPhase 1/2NCT02318277

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

A Phase 1/2 study testing MEDI4736 and INCB024360 in people with Solid Tumors and Head and Neck Cancer, run by Incyte Corporation at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumors, Head and Neck Cancer, Lung Cancer
What is being tested?: MEDI4736 and INCB024360
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 176 participants
Where: 13 sitesUnited States
Study dates: 5 Jan 2015to 16 Oct 2020
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Study site
Chicago, Illinois
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Durham, North Carolina
Study site
Houston, Texas
Study site
Huntersville, North Carolina
Study site
Louisville, Kentucky
Study site
Miami, Florida
Study site
Port Saint Lucie, Florida
Study site
San Francisco, California
Study site
Sarasota, Florida
Study site
Tampa, Florida
Study site
Winston-Salem, North Carolina

Other trials in United States

About this study

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)

Conditions: Solid Tumors, Head and Neck Cancer, Lung Cancer, UC (Urothelial Cancer)
Being tested: MEDI4736, INCB024360
Medical subject headings: Head and Neck Neoplasms, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MEDI4736Drug
MEDI4736 administered intravenously (IV) every two weeks (q2w)
INCB024360Drug
INCB024360: Oral daily dosing

Study groups in NCT02318277
Study group	Role	What they receive
MEDI4736 + INCB024360	Experimental	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 Receives: Drug: MEDI4736; Drug: INCB024360

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Duration of study treatment and up to 90 days after the last dose [approximately 3 years]
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.
Measured: Measured every 8 weeks for duration of study treatment [approximately 12 months]

Secondary outcomes (8)

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
Measured: Measured every 8 weeks for duration of study treatment [approximately 6 months]
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
Measured: Continuously for duration of study treatment and up to 90 days after the last dose [approximately 3 years]
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.
Measured: Measured every 8 weeks for duration of active study treatment [approximately 24 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
Measured: Measured every 8 weeks for duration of active study treatment [approximately 24 months]
Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Measured by Peak Concentration
Measured: Pre dose, 0.5, 1,2, 4.6.& 8 hrs Post dose on C1D1,C1D8,C2D1
Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Measured by Time to Maximal Observed Concentration
Measured: Pre dose, 0.5, 1,2, 4.6.& 8 hrs Post dose on C1D1,C1D8,C2D1
Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Area Under the Concentration-time Curve
Measured: Pre dose, 0.5, 1,2, 4.6.& 8 hrs Post dose on C1D1,C1D8,C2D1
Phase 1 and 2: Immunogenicity of MEDI4736 as Measured by the Number and Percentage of Subjects Who Develop Detectable Anti-drug Antibodies (ADAs)
Measured: Measured at defined study visits from Cycle 1 Day 1 through cycle 2 [approximately 2 weeks].

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jan 201516 Oct 2020

First posted17 Dec 2014 (estimated)
Study start5 Jan 2015
Primary completion28 Aug 2019
Study completion16 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Solid TumorsStudies of the same condition, open and under way.
More trials run by Incyte CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 176 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02318277
Sponsor's protocol ID: INCB 24360-203 / ECHO-203
Status last verified: Jan 2022
First submitted: 19 Nov 2014
Last updated: 13 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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All Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT02318277
Acronym / sponsor ID: INCB 24360-203 / ECHO-203
Conditions: Solid Tumors, Head and Neck Cancer, Lung Cancer, UC (Urothelial Cancer)
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 176 participants (actual)
Lead sponsor: Incyte CorporationIndustry (pharma, biotech, devices)
Collaborators: AstraZeneca
Study start: 5 Jan 2015 (actual)
Primary completion: 28 Aug 2019 (actual)
Study completion: 16 Oct 2020 (actual)
First posted: 17 Dec 2014 (estimated)
Results: Posted 29 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MEDI4736 + INCB024360	Experimental	Drug: MEDI4736, Drug: INCB024360MEDI4736 at selected dose levels every 2 weeks + INCB024360 25 mg BID as starting dose, followed by dose escalations until MTD or PAD is identified

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MEDI4736MEDI4736 administered intravenously (IV) every two weeks (q2w)	Drug	MEDI4736 + INCB024360
INCB024360INCB024360: Oral daily dosing	Drug	MEDI4736 + INCB024360

Primary outcome

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
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.

8 secondary outcomes

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]
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]
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]
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]
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
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
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
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].

Results and safety

Results posted to the registry on 29 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)	6	0
Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)	3	0
Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)	4	0
Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)	4	0
Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)	8	0
Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)	9	0
Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)	49	0
Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)	93	0

Primary outcome: 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]. Count of participants. Unit: Participants

Measure	Phase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg) n = 6	Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg) n = 3	Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg) n = 4	Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg) n = 4	Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg) n = 8	Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg) n = 9
Value	6	3	4	4	8	9

Population analysed: The Phase 1 safety population includes all subjects enrolled in the Phase 1 portion of the study who received at least 1 dose of INCB024360 or MEDI4736. Treatment groups were determined according to the actual treatment the subject received on Day 1 regardless of the actual study drug the subject received during participation in the study.

Primary outcome: 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]. Count of participants. Unit: Participants

Measure	Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg) n = 49	Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg) n = 93
Value	6	12

Population analysed: Intent-to-Treat Population : All subjects who are enrolled in the Phase 2 portion of the study.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Duration of study treatment and up to 90 days after the last dose [approximately 3 years]. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)	2 of 6 (33.3%)	6 of 6 (100%)	5 of 6
Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)	0 of 3 (0%)	3 of 3 (100%)	3 of 3
Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)	2 of 4 (50%)	4 of 4 (100%)	1 of 4
Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)	0 of 4 (0%)	4 of 4 (100%)	4 of 4
Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)	4 of 8 (50%)	8 of 8 (100%)	6 of 8
Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)	3 of 9 (33.3%)	9 of 9 (100%)	5 of 9
Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)	20 of 49 (40.8%)	48 of 49 (98%)	35 of 49
Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)	54 of 93 (58.1%)	87 of 93 (93.5%)	58 of 93

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36309837Naing 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.

Related trials for Solid Tumors

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lance Leopold, MD study director

Incyte Corporation

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MEDI4736 and INCB024360 in people with Solid Tumors and Head and Neck Cancer, run by Incyte Corporation at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02318277, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.