Treating Patients With Melanoma and ALK Alterations With Ensartinib

Description

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.

Study Start Date

January, 10 2018

Estimated Completion Date

January 2020

Interventions

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

Study ID

Memorial Sloan Kettering Cancer Center -- 17-471

Status

Unknown

Trial ID

NCT03420508

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

18

Sponsor

Memorial Sloan Kettering Cancer Center

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:
  • progressing 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).
  • 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.
  • 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 0-1
  • 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)
  • Serum creatinine ?1.5 x ULN
  • Hemoglobin ?9 g/dL
  • Neutrophils ?1.5 x 10^9/L
  • Platelets ?100 x 10^9/L
  • Prothrombin time, international normalized ratio [INR], and/or activated partial thromboplastin time within ?1.5 x ULN
  • Prothrombin time, international normalized ratio [INR], and/or activated partial thromboplastin time within ?1.5 x ULN

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 with the exception of 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.
  • Known HIV infection, solid organ transplantation, or other immunosuppressed state
  • 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.

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (3)

Study Location Distance Name Phone Email
Memorial Sloan Kettering Westchester - Harrison, New York 28.7 miles Alexander Shoushtari MD 646-888-4161 None
Memorial Sloan Kettering Cancer Center - New York, New York 50.7 miles Alexander Shoushtari MD 646-888-4161 None
Memoral Sloan Kettering Monmouth - Middletown, New Jersey 72.7 miles Alexander Shoushtari MD 646-888-4161 None

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