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

Phase 1

Active, not recruiting

• Conditions: Advanced neuroendocrine neoplasias G3 (NEN G3) (excluding SCLC and Merkel cell carcinomas); MedDRA version: 20.0Level: PTClassification code 10057270Term: Neuroendocrine carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-000986-34-DE
• Lead Sponsor: niversity Medical Center of the Johannes Gutenberg-University Mainz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Not 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

- Merkel Cell carcinoma (MCC) or small cell lung cancer (SCLC)
- 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
- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified