Solid TumorsPhase 1/2NCT03361228
A Study to Evaluate the Safety, Tolerability, and Antitumor Activity of INCB001158 Plus Epacadostat, With or Without Pembrolizumab, in Advanced Solid Tumors
A Phase 1/2 study testing INCB001158, Epacadostat and Pembrolizumab in people with Solid Tumors, run by Incyte Corporation at 2 sites in United States.
Trial summary
The purpose of this study is to assess the safety and antitumor activity of INCB001158 plus epacadostat, with or without pembrolizumab, in participants with advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- INCB001158, Epacadostat and Pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2018to 30 Mar 2019
- 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
- For Phase 1, subjects with histologically or cytologically confirmed advanced or metastatic solid tumors that have failed prior standard therapy (disease progression; subject intolerance is also allowable).
- For Phase 2, subjects with the following tumor types who meet protocol-defined criteria: advanced or metastatic NSCLC, melanoma, urothelial carcinoma, SCCHN, SCLC, and CRC.
- Presence of at least 1 measurable lesion by computed tomography or magnetic resonance imaging per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
- Resolution of all toxicities and any toxic effect(s) of the most recent prior therapy to Grade 1 or less (except alopecia). Subjects with ≤ Grade 2 neuropathy are an exception and may enroll.
- Adequate renal, hepatic, and hematologic functions per protocol-defined laboratory parameters within ≤ 7 days before treatment initiation.
Who cannot join
- Participation in any other study in which receipt of an investigational study drug or device occurred within 2 weeks or 5 half-lives (whichever is longer) before first dose.
- Has received a prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is shorter) before administration of study drug.
- Prior chemotherapy or targeted small molecule therapy within 2 weeks before administration of study treatment.
- Prior therapy with an IDO1 or arginase 1 inhibitor.
- Active autoimmune disease that has required systemic treatment in past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Receipt of a live vaccine within 30 days before the first dose of study treatment.
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- Any history of serotonin syndrome after receiving serotonergic drugs.
- Use of protocol-defined prior/concomitant therapy.
- Known or suspected defect in the function of the urea cycle.
- History of gastrointestinal condition that may affect drug absorption.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama
Birmingham, Alabama, 35294-3300
The University of Chicago Medicine
Chicago, Illinois, 60637
About this study
Official title: An Open-Label, Multicenter, Nonrandomized, Dose-Escalation, and Tumor-Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability, and Antitumor Activity of INCB001158 Plus Epacadostat (INCB024360), With or Without Pembrolizumab, in Subjects With Advanced Solid Tumors
The purpose of this study is to assess the safety and antitumor activity of INCB001158 plus epacadostat, with or without pembrolizumab, in participants with advanced or metastatic solid tumors.
- Conditions
- Solid Tumors
- Being tested
- INCB001158, Epacadostat, Pembrolizumab
- Keywords
- Non-small cell lung cancer (NSCLC), melanoma, urothelial carcinoma, squamous cell carcinoma of the head and neck (SCCHN), small cell lung cancer (SCLC), colorectal cancer (CRC), arginase 1 inhibitor, indoleamine 2,3-dioxygenase 1 inhibitor, programmed death-1 receptor (PD-1) inhibitor
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Melanoma, Carcinoma, Transitional Cell, Squamous Cell Carcinoma of Head and Neck, Small Cell Lung Carcinoma, Colorectal Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB001158Drug
Phase 1: INCB001158 administered orally twice daily at the protocol-defined dose. Phase 2: INCB001158 administered orally twice daily at the recommended dose from Phase 1.
EpacadostatDrug
Also called INCB024360
Epacadostat at the protocol-defined dose administered orally twice daily.
PembrolizumabDrug
Also called MK-3475
Pembrolizumab at the protocol-defined dose administered intravenously every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| INCB001158 + Epacadostat + Pembrolizumab | Experimental | Not described Receives: Drug: INCB001158; Drug: Epacadostat; Drug: Pembrolizumab |
| INCB001158 + Epacadostat | Experimental | Not described Receives: Drug: INCB001158; Drug: Epacadostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 Only: Safety and Tolerability of INCB001158 in Combination With Epacadostat ± Pembrolizumab as Assessed by Number of Participants With a Treatment-emergent Adverse Event (TEAE)
TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment.
Measured: Up to approximately 12 months per subject
Phase 2 Only: Objective Response Rate (ORR) of INCB001158 in Combination With Epacadostat ± Pembrolizumab
Defined as percentage of subjects having a complete response (CR) or partial response (PR) based on investigator assessment per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Measured: Up to approximately 12 months per subject
Secondary outcomes (6)
Phase 2 Only: Safety and Tolerability of INCB001158 in Combination With Epacadostat ± Pembrolizumab as Assessed by Number of Participants With a TEAE
TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment.
Measured: Up to approximately 12 months per subject
Phase 1 Only: ORR With INCB001158 in Combination With Epacadostat ± Pembrolizumab
Defined as percentage of subjects having a CR or PR based on investigator assessment per RECIST v1.1.
Measured: Up to approximately 12 months per subject
Disease Control Rate With INCB001158 in Combination With Epacadostat ± Pembrolizumab
Defined as percentage of subjects having CR, PR, or stable disease for at least 56 days based on investigator assessment per RECIST v1.1.
Measured: Up to approximately 12 months per subject
Duration of Response With INCB001158 in Combination With Epacadostat ± Pembrolizumab
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: Up to approximately 12 months per subject
Progression-free Survival With INCB001158 in Combination With Epacadostat ± Pembrolizumab
Defined as the time from date of first dose of study treatment until the earliest date of disease progression (based on investigator assessment of per RECIST v1.1) or death due to any cause, if occurring sooner than progression.
Measured: Up to approximately 12 months per subject
Plasma Pharmacokinetic Profile of INCB001158 and Epacadostat
Noncompartmental method of analysis will be used to analyze the plasma concentrations of INCB001158 and epacadostat.
Measured: Up to approximately 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start1 Mar 2018
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
Why it stopped: Study was terminated early based on emerging data with epacadostat and pembrolizumab.
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sven Gogov, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361228
- Sponsor's protocol ID
- INCB 01158-202
- Status last verified
- May 2020
- First submitted
- 28 Nov 2017
- Last updated
- 21 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Nonrandomized, Dose-Escalation, and Tumor-Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability, and Antitumor Activity of INCB001158 Plus Epacadostat (INCB024360), With or Without Pembrolizumab, in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03361228
- Acronym / sponsor ID
- INCB 01158-202
- Conditions
- Solid Tumors
- Keywords
- Non-small cell lung cancer (NSCLC), melanoma, urothelial carcinoma, squamous cell carcinoma of the head and neck (SCCHN), small cell lung cancer (SCLC), colorectal cancer (CRC), arginase 1 inhibitor, indoleamine 2,3-dioxygenase 1 inhibitor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated early based on emerging data with epacadostat and pembrolizumab.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 4 Dec 2017 (actual)
- Results
- Posted 21 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and antitumor activity of INCB001158 plus epacadostat, with or without pembrolizumab, in participants with advanced or metastatic solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INCB001158 + Epacadostat + Pembrolizumab | Experimental | Drug: INCB001158, Drug: Epacadostat, Drug: Pembrolizumab |
| INCB001158 + Epacadostat | Experimental | Drug: INCB001158, Drug: Epacadostat |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- For Phase 1, subjects with histologically or cytologically confirmed advanced or metastatic solid tumors that have failed prior standard therapy (disease progression; subject intolerance is also allowable).
- For Phase 2, subjects with the following tumor types who meet protocol-defined criteria: advanced or metastatic NSCLC, melanoma, urothelial carcinoma, SCCHN, SCLC, and CRC.
- Presence of at least 1 measurable lesion by computed tomography or magnetic resonance imaging per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
- Resolution of all toxicities and any toxic effect(s) of the most recent prior therapy to Grade 1 or less (except alopecia). Subjects with ≤ Grade 2 neuropathy are an exception and may enroll.
Key exclusion criteria (10 listed)
- Participation in any other study in which receipt of an investigational study drug or device occurred within 2 weeks or 5 half-lives (whichever is longer) before first dose.
- Has received a prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is shorter) before administration of study drug.
- Prior chemotherapy or targeted small molecule therapy within 2 weeks before administration of study treatment.
- Prior therapy with an IDO1 or arginase 1 inhibitor.
- Active autoimmune disease that has required systemic treatment in past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
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 |
|---|---|---|
| INCB001158Phase 1: INCB001158 administered orally twice daily at the protocol-defined dose. Phase 2: INCB001158 administered orally twice daily at the recommended dose from Phase 1. | Drug | INCB001158 + Epacadostat, INCB001158 + Epacadostat + Pembrolizumab |
| EpacadostatAlso: INCB024360Epacadostat at the protocol-defined dose administered orally twice daily. | Drug | INCB001158 + Epacadostat, INCB001158 + Epacadostat + Pembrolizumab |
| PembrolizumabAlso: MK-3475Pembrolizumab at the protocol-defined dose administered intravenously every 3 weeks. | Drug | INCB001158 + Epacadostat + Pembrolizumab |
Primary outcome
Phase 1 Only: Safety and Tolerability of INCB001158 in Combination With Epacadostat ± Pembrolizumab as Assessed by Number of Participants With a Treatment-emergent Adverse Event (TEAE)
Time frame: Up to approximately 12 months per subject
TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment.
Phase 2 Only: Objective Response Rate (ORR) of INCB001158 in Combination With Epacadostat ± Pembrolizumab
Time frame: Up to approximately 12 months per subject
Defined as percentage of subjects having a complete response (CR) or partial response (PR) based on investigator assessment per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
6 secondary outcomes
Phase 2 Only: Safety and Tolerability of INCB001158 in Combination With Epacadostat ± Pembrolizumab as Assessed by Number of Participants With a TEAE
Time frame: Up to approximately 12 months per subject
Phase 1 Only: ORR With INCB001158 in Combination With Epacadostat ± Pembrolizumab
Time frame: Up to approximately 12 months per subject
Disease Control Rate With INCB001158 in Combination With Epacadostat ± Pembrolizumab
Time frame: Up to approximately 12 months per subject
Duration of Response With INCB001158 in Combination With Epacadostat ± Pembrolizumab
Time frame: Up to approximately 12 months per subject
Progression-free Survival With INCB001158 in Combination With Epacadostat ± Pembrolizumab
Time frame: Up to approximately 12 months per subject
Plasma Pharmacokinetic Profile of INCB001158 and Epacadostat
Time frame: Up to approximately 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sven Gogov, MD study director
Incyte Corporation
2 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 INCB001158, Epacadostat and Pembrolizumab in people with Solid Tumors, run by Incyte Corporation at 2 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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 21 May 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 Only: Safety and Tolerability of INCB001158 in Combination With Epacadostat ± Pembrolizumab as Assessed by Number of Participants With a Treatment-emergent Adverse Event (TEAE) (time frame: Up to approximately 12 months per subject). 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?
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 21 May 2020.