Treating Patients With Melanoma and ALK Alterations With Ensartinib

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

January 10, 2018

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2026

Conditions
Melanoma
Interventions
DRUG

Ensartinib

Ensartinib will be given at a dose of 225mg daily in the form of 100mg and 25mg capsules. Patients will receive treatment continuously in 28 day cycles. Patients will then have the same tumor specimen biopsied again at day 15. Treatment will continue until disease progression, unacceptable toxicity, or patient choice to discontinue therapy.

DIAGNOSTIC_TEST

ALKATI by Customized Nanostring Assay

a custom chip with probes targeting the ATI site in ALK, providing a reproducible, quantitative measure of ALKATI

Trial Locations (4)

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Westchester, Harrison

07748

Memorial Sloan Kettering Monmouth, Middletown

07645

Memorial Sloan Kettering Bergen, Montvale

All Listed Sponsors
collaborator

Xcovery Holdings, Inc.

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER