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:<ul>
<li>Are diagnosed with stage 3 or stage 4 unresectable melanoma</li>
<li>Did not respond to previous treatment with anti-PD1 therapy</li></ul>
For more information about who can join this study, please contact the study team at carol.wiggs@duke.edu.
<li>Are diagnosed with stage 3 or stage 4 unresectable melanoma</li>
<li>Did not respond to previous treatment with anti-PD1 therapy</li></ul>
For more information about who can join this study, please contact the study team at carol.wiggs@duke.edu.
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?
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:<ul>
<li>Have a physical exam</li>
<li>Answer questionnaires</li>
<li>Have blood draws</li>
<li>Have imaging scans (X-Ray, MRI, CT, or PET)</li>
<li>Have a tumor biopsy (only if we do not already have a sample from you)</li></ul>
If you are eligible to proceed to the study dosing period, you will:
<li>Take Dapansutrile by mouth twice per day</li>
<li>Get Pembrolizumab through a vein in your arm (IV) every 3 weeks</li>
<li>Have physical exams</li>
<li>Have blood draws</li>
<li>Give urine samples</li>
<li>Have regular MRI or CT scans during the study</li></ul>
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.
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:<ul>
<li>Have a physical exam</li>
<li>Answer questionnaires</li>
<li>Have blood draws</li>
<li>Have imaging scans (X-Ray, MRI, CT, or PET)</li>
<li>Have a tumor biopsy (only if we do not already have a sample from you)</li></ul>
If you are eligible to proceed to the study dosing period, you will:
<li>Take Dapansutrile by mouth twice per day</li>
<li>Get Pembrolizumab through a vein in your arm (IV) every 3 weeks</li>
<li>Have physical exams</li>
<li>Have blood draws</li>
<li>Give urine samples</li>
<li>Have regular MRI or CT scans during the study</li></ul>
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.
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