Purpose of this Study
We are doing this study to find out if an experimental drug called acasunlimab (the study drug) is a safe and effective option for adults with relapsed/refractory, unresectable, locally advanced, or metastatic cutaneous melanoma that has progressed despite treatment with a checkpoint inhibitor. We want to know how well the study drug works on its own and in combination with pembrolizimab.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with cutaneous melanoma
- Have disease that is relapsed/refractory (does not improve with treatment or comes back afterward), locally advanced unresectable (Stage IIIB, IIIC, or IIID), or metastatic (Stage IV - has spread)
- Have received previous, unsuccessful treatment that included a PD-1 blocking antibody
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
If you choose to join this study, you will go through a 28-day screening period to find out it if you are eligible to take part.
If you are eligible, you will get a random assignment (like a coin flip) to 1 of 2 groups. You will either:
- Take the study drug on its own; OR
- Take the study drug in combination with pembrolizumab
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
Efficacy and Safety Study of Acasunlimab as Monotherapy and in Combination
With Pembrolizumab in Subjects With Relapsed/Refractory, Unresectable Locally
Advanced or Metastatic Cutaneous Melanoma That Progressed On or After
Treatment With a Checkpoint Inhibitor
With Pembrolizumab in Subjects With Relapsed/Refractory, Unresectable Locally
Advanced or Metastatic Cutaneous Melanoma That Progressed On or After
Treatment With a Checkpoint Inhibitor
Principal Investigator
April
Salama
Protocol Number
PRO00118084
NCT ID
NCT06984328
Phase
II
Enrollment Status
Pending Open to Enrollment