Ensartinib for Melanoma

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Strong CYP3A inhibitors

Disqualifiers: Prior ALK inhibition, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 24 weeks

18 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications, but it does mention that you cannot have received certain cancer therapies or strong CYP3A inhibitors or inducers recently. It's best to discuss your current medications with the trial team.

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.

Research Team

Alexander Shoushtari

Principal Investigator

Memorial Sloan Kettering Cancer Center

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive ensartinib orally at a dose of 225mg daily

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Ensartinib

Trial Overview 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.

Participant Groups

Group I: ensartinib Experimental Treatment 2 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:

• ALK-positive non-small cell lung cancer

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Xcovery Holdings, Inc.

Industry Sponsor

Trials

10

Recruited

620+

Xcovery Holding Company, LLC

Industry Sponsor

Trials

9

Recruited

530+