A phase Ib/II, multicenter, study of LEE011 in combination with LGX818 in adult patients with BRAF mutant melanoma - LEE011 and LGX818 in BRAF mutant melanoma

ovartis0 个研究点目标入组 14 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•1. Adult with histologically confirmed diagnosis of locally advanced or metastatic melanoma along with written documentation of any BRAF V600 mutation.
•2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
•3. Patients must have evidence of evaluable and/or measurable disease, by RECIST v1.1.
•4. A representative tumor sample is available for molecular testing
•5. A sufficient interval must have elapsed, Cytotoxic chemotherapy >= 2 weeks, biologic therapy >= 4 weeks.
•6. A negative serum βHCG test <= 72 hours before starting study treatment for premenopausal women and for women < 1 years after the onset of menopause

•1. Symptomatic brain metastases. Asymptomatic stable metastases are allowed.
•2. Symptomatic or untreated leptomeningeal disease.
•3. Patients with the abnormal laboratory values during screening, please check protocol for specific info: ANC, Hgb, platelets, serum creatine, serum total bilirubine, ASAT and ALAT
•4. Impairment of gastro-intestinal function /GI disease that may significantly alter the absorption
•5. In the phase II BRAFi naïve arms (1a/b), prior exposure to CDK4/6 inhibitor
•6. Impaired cardiac function or clinically significant cardiac diseases, including any of the following: LVEF <= 45%, QTcF >450 ms for males and >470 ms for females.
•7. Patients who are currently receiving treatment QTc prolongators
•8. History of thromboembolic or cerebrovascular events within the last 6 months,
•9. Patients with concurrent severe and/or uncontrolled concurrent medical conditions
•10. Previous or concurrent malignancy.
•11. Major surgery < 2 weeks before starting study treatment
•12. Patients unwilling or unable to comply with the protocol
•13. Known diagnosis of human immunodeficiency virus (HIV) or hepatitis C
•14. Pregnant or nursing (lactating) women
•15. Women of child-bearing potential, unless highly effective methods of contraception or post-menopausal. Sexually active male must use a condom during intercourse

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