MelanomaPhase 1/2NCT01604889
A Phase 1/2 Randomized, Blinded, Placebo Controlled Study of Ipilimumab in Combination With Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma
A Phase 1/2 study testing Epacadostat and ipilimumab in people with Melanoma, run by Incyte Corporation at 7 sites in United States.
Trial summary
The study design included an open-label, dose escalation phase followed by a blinded, randomized phase, which combined epacadostat (an oral IDO1 inhibitor) with an approved therapy and compared to approved therapy plus placebo in metastatic melanoma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Epacadostat and ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 7 sitesUnited States
- Study dates
- 29 Mar 2012to 20 Jan 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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, aged 18 years or older with unresectable or metastatic melanoma.
- A life expectancy of >12 weeks.
- Laboratory ranges and medical criteria met, as defined within the protocol.
- Subject may have received more than 1 prior regimen of systematic treatment for unresectable or metastatic melanoma.
- For Phase 2 period of the study only, Subjects must have archival tumor tissue available and collected with the prior 6 months or accessible disease for pre-treatment, study biopsy.
Who cannot join
- Pregnant or nursing women.
- Current investigational trial participation with another investigational product or subjects who have received any anticancer medications within 21 days prior to screening (6 weeks for mitomycin-C or nitrosoureas.)
- Subjects receiving monoamine oxidase inhibitors (MAOI)s; subjects who have ever had Serotonin Syndrome after receiving one or more serotonergic drugs.
- Subjects who have received prior immune checkpoint inhibitors (eg anti-CTLA-4, anti-programmed death 1 (PD-1), anti-programmed death-ligand 1 (PD-L1) and others) who have had Grade 3 or 4 hepatotoxicity, immune colitis requiring infliximab, endocrine toxicity not controlled by replacement, any other Grade 4 immune adverse events (AEs) or ocular toxicity
- Subjects with protocol-specified active autoimmune process except vitiligo or thyroiditis.
- Subjects with concurrent conditions that would jeopardize the safety of the safety of the subject or compliance with the protocol.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Study site
Chicago, Illinois
Study site
Durham, North Carolina
Study site
Los Angeles, California
Study site
Miami, Florida
Study site
Philadelphia, Pennsylvania
Study site
Pittsburgh, Pennsylvania
Study site
Tampa, Florida
About this study
The study design included an open-label, dose escalation phase followed by a blinded, randomized phase, which combined epacadostat (an oral IDO1 inhibitor) with an approved therapy and compared to approved therapy plus placebo in metastatic melanoma patients.
Only Phase 1 of the study, dose escalation phase, was conducted. The study was terminated due to a business decision.
- Conditions
- Melanoma
- Being tested
- Epacadostat, ipilimumab
- Keywords
- Melanoma, Skin Cancer, Oncology
- Medical subject headings
- Melanoma, Skin Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpacadostatDrug
Also called INCB024360
ipilimumabDrug
ipilimumab 3 mg/kg intravenous (IV)
| Study group | Role | What they receive |
|---|---|---|
| Epacadostat 25 mg | Experimental | 25 mg BID in combination with ipilimumab Receives: Drug: Epacadostat; Drug: ipilimumab |
| Epacadostat 50 mg | Experimental | 50 mg BID in combination with ipilimumab. 50 mg BID Int indicates 50 mg BID daily 2 weeks on and 1 week off. Receives: Drug: Epacadostat; Drug: ipilimumab |
| Epacadostat 75 mg | Experimental | 75 mg once a day (QD) in combination with ipilimumab. 75 mg total daily dose indicates 50 mg every day before noon (QAM ) and 25 mg every day after noon (QPM). Receives: Drug: Epacadostat; Drug: ipilimumab |
| Epacadostat 100 mg | Experimental | 100 mg twice daily (BID) in combination with ipilimumab Receives: Drug: Epacadostat; Drug: ipilimumab |
| Epacadostat 300 mg | Experimental | 300 mg twice daily (BID) in combination with ipilimumab Receives: Drug: Epacadostat; Drug: ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Number of patients with adverse events as a measure of Safety and Tolerability.
Measured: Baseline and minimally every 3 weeks until discontinuation or death (estimated timeframe to be 29 months from first patient enrolled to last patient discontinued or dead).
Phase 2: Overall survival.
Measured: Measured every 4 weeks until the 50th death occurs, then follow-up is measured every 3 months (estimated timeframe to be 29 months from first patient enrolled to last patient death).
Secondary outcomes (2)
Preliminary efficacy as assessed by tumor response.
Measured: Baseline and every nine weeks (3 cycles) thereafter (estimated timeframe is that each patient will be on study for 11 months).
Evaluation of progression free survival.
Measured: Measured every 4 weeks until the 50th death occurs, then follow-up is measured every 3 months (estimated timeframe is that patients will progress after 11 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2012 (estimated)
- Study start29 Mar 2012
- Primary completion27 Dec 2016
- Study completion20 Jan 2017
Why it stopped: Further development of this compound with ipilimumab in the treatment of melanoma is no longer being pursued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lance Leopold, M.D., Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604889
- Sponsor's protocol ID
- INCB 24360-201
- Status last verified
- Apr 2026
- First submitted
- 9 May 2012
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Gibney GT, Hamid O, Lutzky J, Olszanski AJ, Mitchell TC, Gajewski TF, Chmielowski B, Hanks BA, Zhao Y, Newton RC, Maleski J, Leopold L, Weber JS. Phase 1/2 study of epacadostat in combination with ipilimumab in patients with unresectable or metastatic melanoma. J Immunother Cancer. 2019 Mar 20;7(1):80. doi: 10.1186/s40425-019-0562-8.
PubMed 30894212
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Randomized, Blinded, Placebo Controlled Study of Ipilimumab in Combination With Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT01604889
- Acronym / sponsor ID
- INCB 24360-201
- Conditions
- Melanoma
- Keywords
- Melanoma, Skin Cancer, Oncology
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Further development of this compound with ipilimumab in the treatment of melanoma is no longer being pursued.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2012 (actual)
- Primary completion
- 27 Dec 2016 (actual)
- Study completion
- 20 Jan 2017 (actual)
- First posted
- 24 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study design included an open-label, dose escalation phase followed by a blinded, randomized phase, which combined epacadostat (an oral IDO1 inhibitor) with an approved therapy and compared to approved therapy plus placebo in metastatic melanoma patients.
Only Phase 1 of the study, dose escalation phase, was conducted. The study was terminated due to a business decision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Epacadostat 25 mg | Experimental | Drug: Epacadostat, Drug: ipilimumab25 mg BID in combination with ipilimumab |
| Epacadostat 50 mg | Experimental | Drug: Epacadostat, Drug: ipilimumab50 mg BID in combination with ipilimumab. 50 mg BID Int indicates 50 mg BID daily 2 weeks on and 1 week off. |
| Epacadostat 75 mg | Experimental | Drug: Epacadostat, Drug: ipilimumab75 mg once a day (QD) in combination with ipilimumab. 75 mg total daily dose indicates 50 mg every day before noon (QAM ) and 25 mg every day after noon (QPM). |
| Epacadostat 100 mg | Experimental | Drug: Epacadostat, Drug: ipilimumab100 mg twice daily (BID) in combination with ipilimumab |
| Epacadostat 300 mg | Experimental | Drug: Epacadostat, Drug: ipilimumab300 mg twice daily (BID) in combination with ipilimumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects, aged 18 years or older with unresectable or metastatic melanoma.
- A life expectancy of >12 weeks.
- Laboratory ranges and medical criteria met, as defined within the protocol.
- Subject may have received more than 1 prior regimen of systematic treatment for unresectable or metastatic melanoma.
- For Phase 2 period of the study only, Subjects must have archival tumor tissue available and collected with the prior 6 months or accessible disease for pre-treatment, study biopsy.
Key exclusion criteria (6 listed)
- Pregnant or nursing women.
- Current investigational trial participation with another investigational product or subjects who have received any anticancer medications within 21 days prior to screening (6 weeks for mitomycin-C or nitrosoureas.)
- Subjects receiving monoamine oxidase inhibitors (MAOI)s; subjects who have ever had Serotonin Syndrome after receiving one or more serotonergic drugs.
- Subjects who have received prior immune checkpoint inhibitors (eg anti-CTLA-4, anti-programmed death 1 (PD-1), anti-programmed death-ligand 1 (PD-L1) and others) who have had Grade 3 or 4 hepatotoxicity, immune colitis requiring infliximab, endocrine toxicity not controlled by replacement, any other Grade 4 immune adverse events (AEs) or ocular toxicity
- Subjects with protocol-specified active autoimmune process except vitiligo or thyroiditis.
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 |
|---|---|---|
| EpacadostatAlso: INCB024360 | Drug | Epacadostat 100 mg, Epacadostat 25 mg, Epacadostat 300 mg, Epacadostat 50 mg, Epacadostat 75 mg |
| ipilimumabipilimumab 3 mg/kg intravenous (IV) | Drug | Epacadostat 100 mg, Epacadostat 25 mg, Epacadostat 300 mg, Epacadostat 50 mg, Epacadostat 75 mg |
Primary outcome
Phase 1: Number of patients with adverse events as a measure of Safety and Tolerability.
Time frame: Baseline and minimally every 3 weeks until discontinuation or death (estimated timeframe to be 29 months from first patient enrolled to last patient discontinued or dead).
Phase 2: Overall survival.
Time frame: Measured every 4 weeks until the 50th death occurs, then follow-up is measured every 3 months (estimated timeframe to be 29 months from first patient enrolled to last patient death).
2 secondary outcomes
Preliminary efficacy as assessed by tumor response.
Time frame: Baseline and every nine weeks (3 cycles) thereafter (estimated timeframe is that each patient will be on study for 11 months).
Evaluation of progression free survival.
Time frame: Measured every 4 weeks until the 50th death occurs, then follow-up is measured every 3 months (estimated timeframe is that patients will progress after 11 months).
Results and safety
The study was stopped early (reason given: Further development of this compound with ipilimumab in the treatment of melanoma is no longer being pursued.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Derived from this study: PubMed 30894212Gibney GT, Hamid O, Lutzky J, Olszanski AJ, Mitchell TC, Gajewski TF, Chmielowski B, Hanks BA, Zhao Y, Newton RC, Maleski J, Leopold L, Weber JS. Phase 1/2 study of epacadostat in combination with ipilimumab in patients with unresectable or metastatic melanoma. J Immunother Cancer. 2019 Mar 20;7(1):80. doi: 10.1186/s40425-019-0562-8.
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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, M.D. study director
Incyte Corporation
7 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 Epacadostat and ipilimumab in people with Melanoma, run by Incyte Corporation at 7 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 5 inclusion and 6 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 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
The study was stopped early (reason given: Further development of this compound with ipilimumab in the treatment of melanoma is no longer being pursued.). Results are not available in the source record.
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 patients with adverse events as a measure of Safety and Tolerability. (time frame: Baseline and minimally every 3 weeks until discontinuation or death (estimated timeframe to be 29 months from first patient enrolled to last patient discontinued or dead).). 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 NCT01604889, 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 21 Apr 2026.