A randomized open-label multi-arm two-part phase II study to assess efficacy and safety of multiple LXH254 combinations in patients with previously treated unresectable or metastatic BRAFV600 or NRAS mutant melanoma | NYU Langone Health

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A randomized open-label multi-arm two-part phase II study to assess efficacy and safety of multiple LXH254 combinations in patients with previously treated unresectable or metastatic BRAFV600 or NRAS mutant melanoma

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Conditions:
Melanoma
Age: Between 18 years - 100 years
Gender: Male or Female

Other Inclusion Criteria:

1. Histologically confirmed unresectable or metastatic cutaneous melanoma. 2. Documentation of BRAFV600 or NRAS mutation in tumor tissue prior to study treatment as determined by local assay agreed by Novartis or as determined by central pre-screening assessment performed at a Novartis designated laboratory.

You may not be eligible for this study if the following are true:

1. All primary central nervous system (CNS) tumors or symptomatic CNS metastases that are neurologically unstable. 2. Insufficient bone marrow, hepatic or renal function at the screening visit. 3. Abnormal EGG as determined by the mean of a triplicate EGG and assessed locally.