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Treating Patients With Melanoma and ALK Alterations With Ensartinib | Clinical Trials | Clareo Health

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Treating Patients With Melanoma and ALK Alterations With Ensartinib

A Phase 2 Study of the ALK Inhibitor Ensartinib for Patients With Melanomas Harboring ALK Alterations or Aberrant ALK Expression

NCT03420508•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to test the effects of the study drug, ensartinib, on the patient and the cancer. Ensartinib is a new, investigational type of treatment for melanoma with a particular type of abnormality.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For Screening Phase:
•Patients ≥18 years of age
•Histologically confirmed advanced malignant melanoma, regardless of subtype
•For Treatment Phase, as above and in addition:
•Progression following PD-1 based checkpoint inhibitor therapy, with or without ipilimumab. Tumors harboring BRAF V600 alterations must also have received prior therapy with BRAF inhibitors (with or without a MEK inhibitor). Patients with uveal melanoma are exempt from PD-1 based progression since there is no accepted standard frontline therapy.
•Tumors must harbor an alteration in ALK using a CLIA-certified laboratory, including, but not limited to, ALKATI, ALK fusions, or ALK mutations.
•Disease must be measurable according to RECIST 1.1. Disease that has undergone local therapy in the past 30 days is not considered measurable unless the investigator has documented progression despite the local therapy.
•° If a patient has consented to the pre-screening portion, has been determined to have ALK alterations, but has no measurable disease, the trial may be favored later, and the patient should be consented (or re-consented) to the treatment portion of the trial at the discretion of the investigator.
•Asymptomatic untreated brain metastases are allowed. Symptomatic metastases that have undergone local therapy with RT or surgery and have not required an increase in steroid dose in prior 2 weeks are allowed. Disease that has undergone local therapy is not considered measurable.
•Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2
+9 more criteria

Exclusion Criteria

•For Screening Phase:
•Any prior ALK inhibition.
•For Treatment Phase, as above and in addition:
•Prior therapy with immune-activating agents within less than 1 cycle length prior to first day of study treatment (e.g. 3 weeks for ipilimumab or pembrolizumab; 2 weeks for nivolumab).
•Prior therapy with BRAF/MEK agents within 3 weeks prior to first day of study treatment.
•Any other systemic or regional anticancer therapy (cytotoxic chemotherapy, embolization) within 3 weeks or 1 cycle length, whichever is shorter, prior to first day of study treatment
•Prior RT or clinically relevant major surgery (e.g. craniotomy, metastasectomy) within 2 weeks prior to first day of study treatment.
•Any other active malignancy other than melanoma that, in the opinion of the investigator, would interfere with study participation.
•Receipt of any other systemic anticancer therapy except for hormonal therapy for a hormonally sensitive (e.g. breast or prostate) cancer.
•Receipt of strong CYP3A inhibitors or inducers per Appendix A.
+14 more criteria

Locations (4)

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

January 10, 2018

Primary Completion Date

January 1, 2027

Completion Date

January 1, 2027

Last Updated

February 5, 2026

Enrollment

ESTIMATED participants

Conditions

Melanoma

Interventions

Ensartinib

DRUG

ALKATI by Customized Nanostring Assay

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Treating Patients With Melanoma and ALK Alterations With Ensartinib

Inclusion Criteria

Exclusion Criteria

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