Dapansutrile Plus Pembrolizumab in Melanoma (DREAM) - Clinical Trial

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
    Medical Oncologist
    Protocol Number
    IRB: PRO00108864
    NCT: NCT04971499
    Phase
    Phase I/II
    ClinicalTrials.gov
    Enrollment Status
    Open for Enrollment
    Participate