Clinical trial · Interventional
Ipilimumab and All-Trans Retinoic Acid Combination Treatment of Advanced Melanoma
NCT02403778CI-TRIAL-00069723completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess the safety and efficacy of combined treatment with Ipilimumab and all-trans retinoic acid (ATRA) in melanoma patients.
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 |
|---|---|---|---|
| Ipilimumab | Drug | Ipilimumab | ALIAS |
| VESANOID | Drug | Tretinoin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Ipilimumab
- description
- Arm A (No VESANOIDTherapy) will receive the standard of care treatment with ipilimumab only, receiving the standard 4 doses of either 3 or 10 mg/kg ipilimumab every 3 weeks.
- interventionNames
- Drug: Ipilimumab
- type
- EXPERIMENTAL
- label
- VESANOID
- description
- Arm B (VESANOID Therapy) will receive the standard 4 doses of either 3 or 10 mg/kg ipilimumab every three weeks plus the supplemental treatment of 150 mg/m2 of VESANOID orally for 3 days surrounding each dose of ipilimumab (day -1, day 0, day +1) for a total of 12 days of VESANOID treatment.
- interventionNames
- Drug: VESANOID
- Drug: Ipilimumab
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: * Patients over the age of 18 year. * Patients diagnosed with advanced melanoma. * Patients that are considered candidates for ipilimumab therapy. * Patients able to understand and willing to sign a written informed consent documents. * Patients willing to have regular blood draws, one before treatment and four during or after treatment. Exclusion Criteria: * Patients under the age of 18. * Patients with Stage I or II, melanoma who are not candidates for Ipilimumab. * Patients that have received systemic treatments within four weeks prior to the beginning of treatment. * Women that are pregnant or nursing. * Patients taking immunosuppressive medications. * Patients with active autoimmune disease. * Patients with known sensitivity to retinoic acid derivatives. * Patients with aspartate aminotransferase (AST), alanine aminotransferase (ALT), or bilirubin \> 2.5 × ULN.
References
Publications (1)
- RESULTTobin RP, Jordan KR, Robinson WA, Davis D, Borges VF, Gonzalez R, Lewis KD, McCarter MD. Targeting myeloid-derived suppressor cells using all-trans retinoic acid in melanoma patients treated with Ipilimumab. Int Immunopharmacol. 2018 Oct;63:282-291. doi: 10.1016/j.intimp.2018.08.007. Epub 2018 Aug 16. PMID 30121453