A Phase II, Open-Label, Multicenter Study of Vemurafenib plus Cobimetinib (GDC-0973) in Unresectable Stage IIIc or Stage IV Melanoma; Response Monitoring and Resistance Prediction with Positron Emission Tomography and Tumor Characteristics. - Vemurafenib plus Cobimetinib in Metastatic Melanoma; REPOSIT.

Werkgroep Immunotherapie Nederland voor Oncologie (WIN-O)0 个研究点目标入组 90 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•Patients with histologically confirmed melanoma, either unresectable stage IIIc or stage IV metastatic melanoma, as defined by AJCC 7th edition.
•Prior BRAF/MEK inhibition is allowed only when given for a period of at most 12 weeks prior to immunotherapy AND no progression is seen on ceCT at the time of discontinuation of BRAF/MEK inhibitor. Prior immunotherapy (including ipilimumab) is allowed.
•Documentation of BRAFV600E or BRAFV600K mutation-positive status in melanoma tumor tissue (archival or newly obtained tumor samples).
•Measurable disease per RECIST v1.1, which are accessible to biopsies.
•Biopsy lesion is within scan reach of diagnostic CT and PET-CT (thorax- abdomen-pelvis)
•ECOG performance status of 0 or 1.
•Male or female patient aged >= 18 years.
•Life expectancy >= 12 weeks.
•Adequate hematologic and end organ function within 14 days prior to first dose of study drug treatment.

•History of prior RAF or MEK pathway inhibitor treatment longer than 21 weeks or shorter than 12 weeks but with clinical or radiological signs of progression.
•Palliative radiotherapy, major surgery or traumatic injury within 14 days prior to the first dose of study treatment.
•Active malignancy within the past 3 years other than melanoma that could potentially interfere with the interpretation of efficacy measures, except for patients with resected BCC or SCC of the skin, melanoma in-situ, carcinoma in-situ of the cervix, and carcinoma in-situ of the breast.
•History of or evidence of retinal pathology, clinically significant cardiac dysfunction, patients with symptomatic CNS lesions, renal or liver dysfunction as described in main protocol (REPOSIT NL48639.031.14).
•Pregnant, lactating, or breast-feeding.
•Unwillingness or inability to comply with study and follow-up procedures (i.e. severe anxiety disorder preventing PET/CT imaging.

发起方

Werkgroep Immunotherapie Nederland voor Oncologie (WIN-O)