Melanoma
Conditions
Keywords
Melanoma, Skin Cancer, Oncology
Brief 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. Only Phase 1 of the study, dose escalation phase, was conducted. The study was terminated due to a business decision.
Interventions
DRUGEpacadostat
DRUGipilimumab
ipilimumab 3 mg/kg intravenous (IV)
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1: Number of patients with adverse events as a measure of Safety and Tolerability. | 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 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
| Measure | Time frame |
|---|---|
| Preliminary efficacy as assessed by tumor response. | 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 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). |
Countries
United States
Contacts
STUDY_DIRECTORLance Leopold, M.D.
Incyte Corporation
Outcome results
None listed