Clinical trial · Interventional
A Phase 1/2 Randomized, Blinded, Placebo Controlled Study of Ipilimumab in Combination With Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Further development of this compound with ipilimumab in the treatment of melanoma is no longer being pursued.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epacadostat | Drug | — | UNRESOLVED |
| ipilimumab | Drug | Ipilimumab | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Epacadostat 25 mg
- description
- 25 mg BID in combination with ipilimumab
- interventionNames
- Drug: Epacadostat
- Drug: ipilimumab
- type
- EXPERIMENTAL
- label
- Epacadostat 50 mg
- description
- 50 mg BID in combination with ipilimumab. 50 mg BID Int indicates 50 mg BID daily 2 weeks on and 1 week off.
- interventionNames
- Drug: Epacadostat
- Drug: ipilimumab
- type
- EXPERIMENTAL
- label
- Epacadostat 75 mg
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDGibney 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. PMID 30894212