Treating Patients With Melanoma and ALK Alterations With Ensartinib

NCT03420508 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 17-471
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Melanoma

Keywords

Ensartinib; ALK Inhibitor; ALK Alterations; Aberrant ALK Expression; 17-471

Outcome Measures

Primary Outcomes (1)

• clinical benefit rate (CBR)

  CBR is defined as any confirmed objective response by Response Evaluation in Solid Tumor (RECIST) 1.1, or stable disease until the 24 week assessment.

  up to 24 weeks

Study Arms (1)

ensartinib

EXPERIMENTAL

The screening portion of the trial will test archival tumor material for the presence of ALKATI using a Nanostring-based RNA assay for any patients deemed to be current or future candidates for this trial. This will require approximately 5 formalin-fixed paraffin- embedded (FFPE) slides of 5-8 micron thickness. For the treatment portion of the study, all patients will receive ensartinib orally at a dose of 225mg daily.

Drug: Ensartinib; Diagnostic Test: ALKATI by Customized Nanostring Assay

Interventions

Ensartinib DRUG

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.

ensartinib

ALKATI by Customized Nanostring Assay DIAGNOSTIC_TEST

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

ensartinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Acceptable liver, renal, and hematological function:
• total bilirubin ≤1.5x upper limit of normal (ULN); patients with Gilbert's Syndrome must have bilirubin ≤3x ULN
• Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤3 x ULN (≤5x if liver metastases are present)
• Estimated glomerular filtration rate (GFR) ≥ 30 mL/min using a cancer-specific GFR Model; the calculator found at: http://tavarelab.cruk.cam.ac.uk/JanowitzWilliamsGFR/
• Hemoglobin ≥9 g/dL

You may not qualify if:

• 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.
• Clinically significant cardiovascular disease, including:
• QTc interval by Bazett's formula \>480 ms
• Symptomatic bradycardia \<45 beats per minute
• Other clinically significant ECG abnormalities (e.g. bundle branch block) may be eligible after discussion with the Principal Investigator
• Clinically uncontrolled hypertension in the investigator's opinion.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Xcovery Holdings, Inc.: collaborator

Study Sites (4)

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Melanoma

Interventions

ensartinib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Alexander Shoushtari

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This single arm, single center, open label Phase 2 trial will utilize a Simon 2 stage design.

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 5, 2018
• Study Start: January 10, 2018
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (4)