Ipilimumab and All-Trans Retinoic Acid Combination Treatment of Advanced Melanoma

• Status: Active, not recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Treatments: Antibodies, Monoclonal; Ipilimumab; Tretinoin

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.