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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT02403778
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • VESANOID — DRUG
    All-trans retinoic acid (ATRA) is a vitamin A derivative that binds the retinoic acid receptor on MDSCs and differentiates immature monocytes into more mature dendritic cells (12). VESANOID is a standard treatment for patients with acute promyelocytic leukemia (APL).
  • Ipilimumab — DRUG
    Ipilimumab is current standard of care treatment for melanoma.

Study Details

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.

Key Dates

Start date
Dec 17, 2015
Status verified
Sep 2023
Primary completion
Aug 31, 2018
Completion
Jan 18, 2023

Study Design

Enrollment
10 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Ipilimumab
    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.
  • Experimental: VESANOID
    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.

Primary Outcome Measure

Number of Adverse Events [ Time Frame: Up to 2 years from the time of study enrollment for each patient. ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado HospitalAuroraColorado80045-

Find similar trials in Aurora, CO

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
University of Colorado Hospital· Aurora, CO

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