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

Phase 1

Conditions: Advanced neuroendocrine neoplasias G3 (NEN G3) (excluding SCLC and Merkel cell carcinomas)
MedDRA version: 20.0Level: PTClassification code: 10057270Term: Neuroendocrine carcinoma Class: 100000004864
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2024-513518-37-00

Lead Sponsor: niversitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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