Cabozantinib in combination with Avelumab in patients refractory to standard chemotherapy with advanced neuroendocrine neoplasias G3 (NEN G3)

Korábbi kezelés

• Vaccination within 4 weeks before the first dose of avelumab and while on trial
• 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
• 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

Más betegség

• 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
• Patients who are at increased risk for severe haemorrhage

Egyéb

• Pregnancy or lactation
• Typical or Atypical Carcinoid of the lung with a Ki67 < 20%

• 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