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.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with stage 3 or stage 4 unresectable melanoma
- Did not respond to previous treatment with anti-PD1 therapy
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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: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.
- 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)
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Study of Dapansutrile Plus Pembrolizumab in Patients with PD-1 Refractory Advanced Melanoma
Principal Investigator
April
Salama
Protocol Number
PRO00108864
NCT ID
NCT04971499
Phase
I/II
Enrollment Status
Open to Enrollment