Adjuvant encorafenib & binimetinib vs. placebo in resected stage II BRAF V600E/K mutated melanoma: a randomized triple-blind Phase III Study incollaboration with the EORTC Melanoma Group. - Not available

PIERRE FABRE MéDICAMENT0 个研究点目标入组 900 人开始时间: 2021年10月18日最近更新: 2024年3月12日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 900

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•Molecular pre-screening
•1. Before any related study activity, written informed consent must be given according to ICH/GCP, and national/local regulations ;
•2. Male or female = 18 years of age;
•3. Surgically resected, with tumor free margins, and histologically/pathologically confirmed new diagnosis of stage II (pT2bpT4bN0) cutaneous melanoma per AJCC 8th edition;
•4. Sentinel node (SN) staged node negative (pN0);
•5. Sentinel node (SN) biopsy within 14 weeks from initial diagnosis of melanoma;
•1. Melanoma determined locally to be V600E/K mutation-positive. Note: only PCR and NGS-based local assay results will be acceptable;
•2. Participant still free of disease as evidenced by the required baseline imaging and physical/dermatological assessments performed within 6 weeks from the randomization (Day 1);
•3. Before any related study activity, written informed consent must be given according to ICH/GCP, and national/local regulations;
•4. Randomization within 12 weeks from SN biopsy;
•5. Able to provide a sufficient amount of representative tumor specimen (diagnostic biopsy) for retrospective central testing of BRAFV600E/K mutation status. FFPE tumor tissue block or a minimum of 10 slides, optimally up to 15 slides;
•6. Recovered from definitive surgery (e.g. complete wound healing, no uncontrolled wound infections or indwelling drains);
•7. ECOG performance status of 0 or 1;
•8. Adequate bone marrow function:
•i. Absolute neutrophil count (ANC) = 1.5 x 1000000000/L
•ii. Platelets = 100 x1000000000 /L
•iii. Hemoglobin = 9.0 g/dL
•9. Adequate renal function:
•Serum creatinine = 1.5 × ULN; or calculated creatinine clearance = 50 mL/min by Cockcroft-Gault formula;
•10. Adequate electrolytes, defined as serum potassium and magnesium levels within institutional normal limits.
•11. Adequate hepatic function:
•i. Serum total bilirubin = 1.5 x ULN and < 2 mg/dL
•ii. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) = 2.5 x ULN
•12. Adequate cardiac function:
•i. Left ventricular ejection fraction (LVEF) = 50% as determined by a multigated acquisition (MUGA) scan or echocardiogram
•ii. Mean triplicate QT interval corrected for heart rate according to Fridericia's formula (QTcF) value = 480 msec and no history of QT syndrome
•13. Negative serum ß-HCG test (female patient of childbearing potential only) performed within 3 days prior to Day 1;
•14. Participants of childbearing / reproductive potential should use adequate birth control measures (see Appendix 4, section 10.4.2):
•Female participants are either postmenopausal for at least 1 year, surgically sterile for at least 6 weeks or must agree to take appropriate precautions to avoid pregnancy.
•Male participants must agree to take appropriate precautions to avoid
•fathering a child.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 720
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 180

排除标准

•Molecular pre-screening
•1. Unknown ulceration status;
•2. Uveal and mucosal melanoma;
•3. Clinically apparent metastases (N+/M1);
•4. Microsatellites, satellites and/or in-transit metastases;
•5. Local (scar) recurrences.
•1. Breast feeding women;
•2. History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes);
•3. History of thromboembolic or cerebrovascular events = 12 weeks prior to randomization;
•i. Note 1: Thromboembolic or cerebrovascular events include stroke, transient ischemic attacks, cerebrovascular accidents, hemodynamically significant (i.e massive or sub-massive) deep vein thrombosis, pulmonary emboli, aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis;
•ii. Note 2: Participants with thromboembolic events related to indwelling catheters or other procedures may be enrolled;
•4. Previous or concurrent malignancy for the past 3 years (must be free from disease for at least 3 years). Except for non-melanoma skin cancer (Basal Cell Carcinomas or Squamous Cell Carcinomas) and any in situ
•5.Participants with a prior cancer associated with RAS mutation;
•6. Previous treatment for melanoma beyond complete surgical resection (any prior systemic anticancer therapy; prior radiotherapy);
•7. Hypersensitivity to the study drugs or to any of the excipients;
•8. Participants with severe lactose intolerance (e.g Rare hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption);
•9.Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following:
•iii. History of acute myocardial infarction, acute coronary syndromes (including unstable angina, coronary artery bypass graft, coronary angioplasty or stenting) = 6 months prior to randomization;
•iv. Congestive heart failure requiring treatment (New York Heart Association Grade = 2);
•v. Uncontrolled hypertension defined as persistent systolic blood pressure = 150 mmHg or diastolic blood pressure = 100 mmHg despite optimal therapy;
•vi. Presence of clinically significant cardiac arrhythmias including uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia (stable controlled atrial fibrillation or paroxysmal supraventricular tachycardia is accepted);
•10. Neuromuscular disorders that are associated with CK > ULN (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy);
•11. Non-infectious pneumonitis and Interstitial Lung Disease;
•12. Positive SARs-CoV-2 or variants of SARs-CoV2 RT-PCR test at screening or suspected to be infected with SARs-CoV2 or variants of SARsCoV2 with confirmation pending;
•13. Known history of a positive serology for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS), known history of a positive serology for active hepatitis B, and/or
•hepatitis C;
•14. Unable to ingest or digest tablets and capsules. This can be caused by any impaired gastrointestinal function or disease, such as for example: ulcerative diseases, malabsorption syndrome, small bowel
•resection, ileus, etc. Or any condition causing uncontrolled nausea, vomiting or diarrhea;
•15. Presence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up s

研究者

发起方

PIERRE FABRE MéDICAMENT

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