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?


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

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 I/II
Enrollment Status
Open for Enrollment