A study to investigate the clinical activity and safety of avelumab in patients with neuroendocrine carcinomas

Phase 1

• Conditions: advanced, metastatic high grade neuroendocrine carcinomas NEC G3 (WHO 2010); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-004373-40-DE
• Lead Sponsor: niversity Medical Center of the Johannes Gutenberg-University Mainz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-15
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- Male or female patient = 18 years
- Histologically proven neuroendocrine neoplasia NEC G3 (WHO 2010)
- One block or 20 slides (4 microns) of archival tumor tissue to perform central pathological review and biomarker assessment
- No curative option available
- Progressive disease within 9 months before study initiation and after prior at least
one chemotherapy (platinum based chemotherapy or STZ/TEM/DTIC based
chemotherapy in NET G3)
- Presence of measurable disease as per RECIST1.1 criteria
- ECOG Performance Status 0 – 2
- 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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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 antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints)
- Neuroendocrine tumors that are potentially curable by surgery
- Major surgery within 4 weeks of first dose of study medication.
- TACE, TAE, SIRT or PRRT within 3 months of starting study treatment
- Patients pretreated with Interferon as last treatment line prior to study entry
- Concurrent anticancer treatment
- active infection requiring systemic therapy including, HIV/AIDS, HBV or HCV
- Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
- Pregnancy or lactation
- Vaccination within 4 weeks of the first dose of avelumab and while on trial

Study & Design

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