Study of Oral Azacitidine (CC-486) in Combination With Pembrolizumab (MK-3475) in Patients With Metastatic Melanoma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02816021
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Azacitidine — DRUG
    300 mg by mouth daily for 15 days (Days 1-15) of every cycle.
  • Pembrolizumab — DRUG
    200 mg by vein every 3 weeks and after the oral dose of Azacitidine on concurrent treatment days.

Study Details

You are being asked to take part in this study because you have advanced melanoma. The goal of this clinical research study is to learn if oral azacitidine (CC-486) and pembrolizumab (MK-3475) can help to control melanoma. The safety of this drug combination will also be studied. This is an investigational study. Azacitidine is FDA approved and commercially available for the treatment of myelodysplastic syndrome (MDS) and acute myeloid leukemia. Pembrolizumab is FDA approved and commercially available for the treatment of melanoma. It is considered investigational to use this drug combination to treat melanoma. The study doctor will explain how the study drugs are designed to work. Up to 71 participants will be enrolled in this study. All will take part at MD Anderson.

Key Dates

Start date
Feb 14, 2017
Status verified
Apr 2026
Primary completion
Mar 19, 2026
Completion
Mar 19, 2026

Study Design

Enrollment
24 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Metastatic Melanoma - PD-1 Naive
    Thirty-six participants with metastatic melanoma that are PD-1 naïve enrolled in treatment Arm A. Treatment consists of 3-week cycles and continues until disease progression. Oral Azacitidine administered by mouth daily for 15 days (Days 1-15) of every cycle. Pembrolizumab administered by vein every 3 weeks and after the oral dose of Azacitidine on concurrent treatment days.
  • Experimental: Arm B: Metastatic Melanoma - Post PD-1 Progression
    Thirty-five participants with metastatic melanoma that have progressed on PD-1 directed therapy enrolled in treatment Arm B. Treatment consists of 3-week cycles and continues until disease progression. Oral Azacitidine administered by mouth daily for 15 days (Days 1-15) of every cycle. Pembrolizumab administered by vein every 3 weeks and after the oral dose of Azacitidine on concurrent treatment days.

Primary Outcome Measure

Objective Response Rate in Participants with Metastatic Melanoma That Are PD-1 Naïve (Arm A) or That Have Progressed on PD-1 Directed Therapy (Arm B) [ Time Frame: After 4 cycles. Each cycle is 21 days. ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77330-

Find similar trials in Houston, TX

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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