A Phase I/IIA Study of LNS8801 with and without Pembrolizumab Immunotherapy in People with Advanced Melanoma

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Full Title

A Multicenter Phase 1-2A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of LNS8801 in Patients With Advanced Cancer With and Without Pembrolizumab

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational drug LNS8801 with and without pembrolizumab immunotherapy in people with advanced melanoma. LNS8801 works to reduce levels of a growth protein called MYC. By reducing these levels, LNS8801 may slow the growth of cancer, shrink the cancer, and help the immune system remove cancer from the body. Pembrolizumab boosts the ability of the immune system to find and kill cancer cells.

Doctors believe that using LNS8801 and pembrolizumab together is more effective than using either medication alone. Participants will receive either LNS8801 alone or with pembrolizumab. LNS8801 is taken orally (by mouth) and pembrolizumab is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have advanced skin or uveal melanoma that cannot be successfully treated with standard therapies.
  • At least 4 weeks must pass between the completion of previous treatments and receipt of the study therapy.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

For more information and to ask about eligibility for this study, please contact the office of Dr. Alexander Shoushtari at 646-888-4161.

Protocol

22-132

Phase

I/II

Co-Investigators