A Study of SEA-CD40 Given with Other Drugs in Cancers (Melanoma)
What is the Purpose of this Study?
If you choose to join this study, you will:
- Get the study drug, SEA-CD40, through a vein in your arm (IV) every 6 weeks
- Get pembrolizumab through IV every 3 weeks
- Have physical exams
- Have blood draws
- Give urine samples
- Have regular MRI or CT scans during the study
- Possibly have a needle biopsy of your tumor
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.
- Get the study drug, SEA-CD40, through a vein in your arm (IV) every 6 weeks
- Get pembrolizumab through IV every 3 weeks
- Have physical exams
- Have blood draws
- Give urine samples
- Have regular MRI or CT scans during the study
- Possibly have a needle biopsy of your tumor
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.
What is the Condition Being Studied?
Melanoma
Who Can Participate in this Study?
Adults ages 18+ who:
- Are diagnosed with melanoma and have not gotten better after 3 rounds of therapy that include an anti-PD-(L)1 monoclonal antibody; OR
- Are diagnosed with metastatic uveal melanoma; OR
- Are diagnosed with metastatic melanoma and have never received an anti-PD-(L)1 monoclonal antibody
For more information about who can be in this study, please contact the study team at carolann.wiggs@duke.edu
Age Group
Adults
Participating Institutions
What is Involved?
We are doing this study to find out if an experimental drug called SEA-CD40 is a safe and effective treatment for melanoma when it's given in combination with pembrolizumab.
Study Details
Full Title
An Open-label, Phase 2 Basket Study of SEA-CD40 Combination Therapies in Advanced Malignancies
Principal Investigator
Protocol Number
IRB:
PRO00108587
NCT:
NCT04993677
ClinicalTrials.gov
View on ClinicalTrials.gov