A phase II, open-label, multicenter trial to investigate the clinical activity and safety ofCabozantinib in combination with avelumab in patients refractory to standardchemotherapy with advanced neuroendocrine neoplasias G3 (NEN G3) - CaboAveNEC

niversitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR0 个研究点目标入组 30 人开始时间: 2024年6月11日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•Age = 18 years, Histologically proven neuroendocrine neoplasia NEN G3 (WHO 2010/2019), One block or 20 slides (4 microns) of archival tumor tissue to perform central pathological review and biomarker assessment and for translational research, No curative option available, Progression after at least one chemotherapy (platinum based or STZ/TEM/DTIC based chemotherapy), Presence of measurable disease as per RECIST1.1 criteria, Adequate organ and bone marrow function, ECOG Performance Status 0 - 1, Written informed consent

•Merkel Cell carcinoma (MCC) or small cell lung cancer (SCLC), Active infection requiring systemic therapy including, HIV/AIDS, HBV, HCV, Covid 19, Severe active autoimmune disease that requires immunomodulatory therapy, Uncontrolled hypertension, Congestive heart failure or symptomatic coronary artery disease, Pregnancy or lactation, Vaccination within 4 weeks before the first dose of avelumab and while on trial, Typical or Atypical Carcinoid of the lung with a Ki67 < 20%, Prior therapy with any TKI or immune therapy, Neuroendocrine tumors that are potentially curable by surgery, Major surgery within 4 weeks before first dose of study medication. Complete wound healing must be observed at least 10 days prior to enrollment, Patients who are at increased risk for severe haemorrhage, TACE, TAE, SIRT or PRRT within 8 weeks before first dose of study medication, Patients pretreated with Interferon as last treatment line prior to study entry, Concurrent anticancer treatment

发起方

niversitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR