Dapansutrile Plus Pembrolizumab in Melanoma (DREAM)

What is the Purpose of this Study?

We are doing this study to find out if the combination of the drugs Dapansutrile and Pembrolizumab is a safe and effective treatment for people with melanoma that does not improve after PD-1 therapy.

What is the Condition Being Studied?

Melanoma

Who Can Participate in the Study?

Adults ages 18+ who:

  • Are diagnosed with stage 3 or stage 4 unresectable melanoma
  • Did not respond to previous treatment with anti-PD1 therapy

For more information about who can join this study, please contact the study team at carol.wiggs@duke.edu.

Age Group
Adults

What is Involved?

The study is divided into 2 periods: a screening period and a study dosing period.

If you choose to join the study, you will go through a screening period to see if you are eligible. During this period, you will:

  • Have a physical exam
  • Answer questionnaires
  • Have blood draws
  • Have imaging scans (X-Ray, MRI, CT, or PET)
  • Have a tumor biopsy (only if we do not already have a sample from you)

If you are eligible to proceed to the study dosing period, you will:

  • Take Dapansutrile by mouth twice per day
  • Get Pembrolizumab through a vein in your arm (IV) every 3 weeks
  • Have physical exams
  • Have blood draws
  • Give urine samples
  • Have regular MRI or CT scans during the study

    • You will receive the study drugs for up to 2 years unless you have unwanted side effects or the study doctor finds that you are not getting better.

    Study Details

    Full Title
    A Study of Dapansutrile Plus Pembrolizumab in Patients with PD-1 Refractory Advanced Melanoma
    Principal Investigator
    Headshot of April Kelly Scott Salama
    Associate Professor of Medicine
    Protocol Number
    IRB: PRO00108864
    NCT: NCT04971499
    Phase
    Phase I/II
    ClinicalTrials.gov
    Enrollment Status
    OPEN TO ACCRUAL
    Participate