Purpose of this Study
We are doing this study to find the most effective, safe dose of an experimental drug called LNS8801 (the study drug) when it is given with or without pembrolizumab to people who have treatment-refractory unresectable melanoma.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with unresectable and/or metastatic cutaneous melanoma
- Are not a candidate for surgery to remove their cancer
- Are eligible and able to receive both standard chemotherapy regimens (e.g., dacarbazine, temozolomide) and immunotherapy regimens (e.g., pembrolizumab, nivolumab/relatlimab, nivolumab/ ipilimumab)
- Have had their disease worsen after treatment with an anti-PD-1 monoclonal antibody (mAb) given either alone or in combination with other drugs
- Have not received any type of anti-cancer therapy for at least 4 weeks before starting the study regimen
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 get a random assignment (fair, equal chance) to 1 of 3 groups. You will either:
- Be assigned to take the study drug on its own; OR
- Be assigned to take the study drug in combination with pembrolizumab; OR
- Be assigned to take whatever approved chemotherapy and/or immunotherapy treatment you and your doctor believe is the best choice for you
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Multicenter, Open-Label, Randomized, Controlled Study to Assess the Antitumor Activity of LNS8801 With and Without Pembrolizumab in Patients With Treatment-Refractory, Unresectable Melanoma
Principal Investigator
April
Salama
Protocol Number
PRO00116636
NCT ID
NCT06624644
Phase
II
Enrollment Status
Pending Open to Enrollment