Ensartinib for Melanoma

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byAlexander Shoushtari

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for adults with advanced malignant melanoma that has a specific ALK alteration. Participants must have tried PD-1 based therapy (and BRAF inhibitors if applicable) without success, and should not be pregnant or breastfeeding. They need to have good liver, kidney, and blood function and can't have used certain other cancer treatments or strong CYP3A affecting drugs recently.

Inclusion Criteria

My cancer progressed after PD-1 therapy, and if it's BRAF V600 positive, I've had BRAF inhibitors.

My liver, kidney, and blood tests are within the required ranges.

My tumor has an ALK alteration.

+5 more

Exclusion Criteria

I have previously received ALK inhibitors for treatment.

I had lung inflammation before, but it's resolved now.

I haven't had any cancer treatments in the last 3 weeks or within the last treatment cycle, whichever is shorter.

+10 more

Participant Groups

The trial is testing ensartinib's effectiveness on melanoma with ALK alterations. Ensartinib is an investigational drug targeting this abnormality in the hope of treating the cancer more effectively.

1Treatment groups

Experimental Treatment

Group I: ensartinibExperimental Treatment2 Interventions

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.

Ensartinib is already approved in United States for the following indications:

🇺🇸 Approved in United States as Ensacove for: