Phase 2
Completed N=10
Ipilimumab and All-Trans Retinoic Acid Combination Treatment of Advanced Melanoma
Source: ClinicalTrials.gov NCT02403778 ↗Enrolled (actual)
10
Serious AEs
50.0%
Results posted
Jul 2019
Primary outcomePrimary: Number of Adverse Events — 51; 45 Number of events in treatment group
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Events |
51; 45 | — |
| PRIMARY MDSC Frequency |
34.35; 7.29 | — |
| PRIMARY MDSC Suppressive Function |
NA; NA | — |
| SECONDARY Changes in the Frequency of Tumor-specific T Cell Responses |
6.0975; 14.2833 | — |
| SECONDARY Unresectable Stage III and STAGE IV |
776; 662 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02403778). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.