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LNS8801 +/- Pembro in Patients with Refractory Melanoma (LNS-103) - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Treatment-Refractory Unresectable Melanoma

Who Can Participate in the Study?

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

For more information, contact the study team at carolann.wiggs@duke.edu.

Grupo etario

Adultos

What is Involved?

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

The study drug is a tablet that you will take by mouth every day. Pembrolizumab is given as an infusion (IV) into a vein in your arm.

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