Study of Trametinib + Ceritinib in Patients With Unresectable Melanoma

  • STATUS
    Recruiting
  • End date
    Jun 4, 2022
  • participants needed
    27
  • sponsor
    H. Lee Moffitt Cancer Center and Research Institute
Updated on 4 March 2021
measurable disease
BRAF
pd-l1
solid tumors
solid tumour
mek inhibitor
unresectable melanoma
mekinist
trametinib
cytotoxic t-lymphocyte antigen 4

Summary

The main purpose of this study is to determine the risks and benefits of ceritinib (ZYKADIA) given in combination with trametinib (MEKINIST) in patients who have progressed on prior melanoma therapy.

Description

Ceritinib that has been approved for patients with metastatic non-small cell lung cancer (NSCLC) by the US Food and Drug Administration (FDA). While ceritinib is not currently FDA-approved specifically in melanoma, researchers believe ceritinib may also help keep melanoma cancer cells from growing and therefore potentially help patients with melanoma as well. Trametinib is currently FDA-approved for melanoma with a BRAFV600-mutation.

Details
Condition melanoma, skin cancer, Metastatic Melanoma, Advanced Melanoma, Unresectable Melanoma, Malignant Melanoma
Treatment Trametinib, Ceritinib
Clinical Study IdentifierNCT03501368
SponsorH. Lee Moffitt Cancer Center and Research Institute
Last Modified on4 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Advanced Melanoma or Metastatic Melanoma or Unresectable Melanoma or skin cancer or Malignant Melanoma or melanoma?
Do you have any of these conditions: Unresectable Melanoma or Malignant Melanoma or skin cancer or Advanced Melanoma or Metastatic Melanoma or melanoma?
Do you have any of these conditions: skin cancer or Metastatic Melanoma or Malignant Melanoma or melanoma or Advanced Melanoma or Unresectable Melanoma?
Diagnosis of advanced/unresectable melanoma (AJCC v.8 Stage 3C/D/4)
Measurable disease, defined as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Must have at least one tumor site accessible for a biopsy
Documented disease refractory to at least one PD1/PD-L1 (+/- CTLA-4) inhibitor treatment, or intolerance to these drugs and if BRAFV600-mutant melanoma, refractory disease to at least one BRAF and MEK inhibitor (defined as progression while on treatment), or intolerance to these drugs
Last line of treatment prior to study enrollment must not have been BRAF/MEK inhibitor therapy
Prior treatment-related toxicity resolved to Grade 2 or baseline
Prior radiation allowed
Eastern Cooperative Oncology Group (ECOG) performance status 2
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for 90 days after completion of trametinib + ceritinib administration
Participants must have normal organ and marrow function

Exclusion Criteria

Potential participants with known hypersensitivity to any of the excipients of trametinib, ceritinib (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate)
An untreated or uncontrolled brain metastases or evidence of leptomeningeal disease. Patients with asymptomatic brain metastases or previously treated brain metastases that are stable (i.e., not requiring corticosteroids) at the time of study start will be eligible
Previous malignancy is not an exclusion provided that the other malignancy is considered under control, patient is not on concomitant anti-cancer drug therapy, and target lesions from melanoma are clearly defined for response assessment
Other severe, acute, or chronic medical conditions including uncontrolled diabetes mellitus or psychiatric conditions or laboratory abnormalities that, in the opinion of the investigator, may increase the risk associated with study participation or may interfere with the interpretation of study results
Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months), such as
unstable angina within 6 months prior to screening
myocardial infarction within 6 months prior to screening
history of documented congestive heart failure (New York Heart Association functional classification III-IV)
cardiac arrhythmias not controlled with medication
Corrected QT (QTcF) >470 ms at baseline
A history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention). (Note, this does NOT include immune-mediated pneumonitis)
Impaired gastrointestinal (GI) function or GI disease that may alter absorption of study drugs or inability to swallow
Receiving medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to start of treatment with study drugs and for the duration of participation
Medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes
Strong inhibitors or strong inducers of CYP3A4/5, and Medications with a low therapeutic index that are primarily metabolized by CYP3A4/5, and/or CYP2C9
Therapeutic doses of warfarin sodium (Coumadin) or any other coumadin-derived anti-coagulant. Anticoagulants not derived from warfarin are allowed (e.g., dabigatran, rivaroxaban, apixaban)
Unstable or increasing doses of corticosteroids in the 5 days before first dose of study treatment
Enzyme-inducing anticonvulsive agents
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