Open-label, phase IIIb study of dabrafenib in COMBInation with trametinib in the Adjuvant treatment of stage III BRAF V600 mutation-positive melanoma after complete resection to evaluate the impact on pyrexia related outcomes of an adapted pyrexia AE-management algorithm (Plus) - COMBI-APlus

ovartis Pharma AG0 个研究点目标入组 600 人开始时间: 2018年8月27日最近更新: 2021年10月8日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: ovartis Pharma AG
入组人数: 600

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

•>18 years of age with Informed consent
•Signed informed consent must be obtained prior to
•participation in the study.
•Completely resected (R0) histologically confirmed cutaneous melanoma stage IIIA (LN metastasis >1 mm), IIIB, IIIC, IIID [AJCC (ed 8)] no more than 12 weeks before enrollment
•V600E/K mutation positive using a validated local test
•Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
•Subject has adequate bone marrow and organ function as defined by the following laboratory values without continuous supportive treatment (such as blood transfusion, coagulation factors and/or platelet infusion, or red/white blood cell growth factor administration) as assessed by laboratory for eligibility:
•- Hematological
•- Coagulation
•- Left ventricular ejection fraction (LVEF) = lower limit of institutional normal (LLN) as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
•Able to swallow and retain oral medication and must
•not have any clinically significant gastrointestinal
•abnormalities that may alter absorption such as
•malabsorption syndrome or major resection of the
•stomach or bowels
•Other protocol-defined inclusion criteria may apply
•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 480
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 120

排除标准

•Uveal or mucosal melanoma
•Evidence of metastatic disease including unresectable in-transit metastasis
•Received any prior adjuvant treatment, including but not limited to chemotherapy, checkpoint inhibitors, targeted therapy [e.g., BRAF and/or MEK inhibitors], biologic therapy, vaccine therapy, investigational treatment, or radiotherapy for melanoma
•Taken an investigational drug within 28 days or 5 half-lives, whichever is longer, prior to enrollment.
•Current or expected use of a prohibited medications (other anticancer therapies, other investigational drugs, antiretroviral drugs, herbal remedies, and drugs that are strong inhibitors or inducers of CYP3A and CYP2C8).
•Non-melanoma related major surgery or significant traumatic injury = 2 weeks prior to start of study treatment. Minor surgical procedures should be completed 7 days prior to start of study treatment
•Known immediate or delayed hypersensitivity
•reaction or idiosyncrasy to drugs chemically related to
•the study treatments, their excipients, and/or dimethyl
•sulfoxide (DMSO)
•Subjects with known history for testing positive for
•Human Immunodeficiency Virus (HIV)
•Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers and any completely resected carcinoma in situ.
•Cardiac or cardiac repolarization abnormality
•A history or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy
•History of clinically significant or active interstitial lung disease or pneumonitis
•Any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), psychiatric disorders, or other conditions that, in the opinion of the investigator, could interfere with the subject’s safety, obtaining
•informed consent, or compliance with study procedures
•Women child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 4 months after stopping study treatment.
•Women who are nursing during dosing and for 4 months after stopping study treatment
•Male subjects (including those that have had a vasectomy) taking study treatment must use a condom during intercourse, and for 16 weeks after stopping treatment, and should not father a child during these periods
•Other protocol-defined exclusion criteria may apply

研究者

发起方

ovartis Pharma AG

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