Study of Oral Azacitidine and Pembrolizumab for Patients with Advanced Melanoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02816021

Provider View

This clinical trial is testing a combination of two drugs, oral azacitidine and pembrolizumab, to see if they can help control advanced melanoma. The study will also look at the safety of using these drugs together.

Patient Parameters

Program Overview

You are being invited to participate in this study because you have advanced melanoma. The study aims to find out if a combination of oral azacitidine and pembrolizumab can help control melanoma. While both drugs are approved for other uses, their combined use for melanoma is still being researched. Up to 71 participants will be involved, all at MD Anderson.

Description

Study Drug Administration:

  • Each treatment cycle lasts 3 weeks.
  • You will take azacitidine by mouth once daily for the first 14 days of each cycle. You may need to keep a Pill Diary to record when you take your medication.
  • You will receive pembrolizumab through an IV on the first day of each cycle.

Study Visits:

  • Cycles 1-3: Physical exam, blood tests, and possibly tumor biopsies.
  • Cycle 4: Physical exam, blood tests, and an MRI or CT scan.
  • Cycle 5: Physical exam, blood tests, and tumor biopsies.
  • Cycles 6 and beyond: Regular exams and blood tests.
  • MRI or CT scans will be done at the end of Cycle 8 and every 4 cycles after.

Length of Study:

  • You may continue treatment for up to 24 months or 35 doses, unless the disease worsens or side effects become too severe.

End-of-Treatment Visit:

  • Blood tests and an MRI or CT scan.
  • Possible tumor biopsies if the disease worsens.

Follow-Up:

  • If you stop treatment for reasons other than disease progression, you will have scans every 12 weeks.
  • If the disease worsens, you may be eligible for additional pembrolizumab treatment.

Safety Follow-Up Visit:

  • About 30 days after your last dose, you will have a physical exam and blood tests.

Long-Term Follow-Up:

  • You will receive a phone call every 12 weeks to check on your health.

Eligibility Criteria

Inclusion Criteria

  • Have advanced melanoma that cannot be surgically removed or has spread.
  • Be 18 years or older.
  • Have measurable disease.
  • Be willing to provide a tumor sample.
  • Have good overall health and organ function.
  • Women of childbearing potential must have a negative pregnancy test and use birth control.
  • Men must agree to use contraception.

Exclusion Criteria

  • Currently in another study or have been in one recently.
  • Have immune system issues or are on immunosuppressive therapy.
  • Have active infections like TB or hepatitis.
  • Have had recent cancer treatments or surgeries without full recovery.
  • Have other active cancers or untreated brain metastases.
  • Have autoimmune diseases needing treatment in the past 2 years.
  • Have significant heart disease or active infections.
  • Are pregnant or breastfeeding.

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