Treating Patients With Melanoma and ALK Alterations With Ensartinib

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.
• •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.
• •The following within 6 months prior to Cycle 1 Day 1:
• •* Congestive heart failure (New York Heart Class III or IV).
• •* Cardiomyopathy.
• •* o Arrhythmia or conduction abnormality requiring medication. Note: patients with atrial fibrillation/flutter adequately controlled by medication in the opinion of the treating physician and arrhythmias controlled by pacemakers are eligible.
• •* Severe/unstable angina, coronary artery/peripheral bypass graft, or myocardial infarction.
• •* Cerebrovascular accident or transient ischemia.
• •Any serious, active infection at the time of treatment such as bacteremia
• •Interstitial lung disease or pneumonitis that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity. Patients with prior pneumonitis that has resolved are eligible.
• •Patients must not be pregnant or breast feeding, or unable or unwilling to use proper contraception during the study and up to 3 months following study completion.