NCT05289856CompletedPhase 2
Cabozantinib in combination with Avelumab in patients refractory to standard chemotherapy with advanced neuroendocrine neoplasias G3 (NEN G3)
A phase II, open-label, multicenter trial to investigate the clinical activity and safety of Cabozantinib in combination with avelumab in patients refractory to standard chemotherapy with advanced neuroendocrine neoplasias G3 (NEN G3)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 26 Jun 2024
Brief summary (registry, in English)
Primary study objective is to assess the clinical activity of the combination therapy of Cabozantinib with Avelumab in comparison to monotherapy with avelumab in the AveNEC trial (EudraCT No.: 2016-004373-40) in patients with progressive Neuroendocrine Neoplasias G3 (NEN G3) after standard chemotherapy. The primary end point is the disease control rate (DCR) according to iRECIST after 16 weeks from start of treatment until documented disease progression (PD). The tumor assessment is done every 8 weeks for the first 6 month and every 12 weeks thereafter.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 11 Jun 2024
- Start date
- 15 Mar 2022
- Lead sponsor
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Diseases
- Lung cancer
- NCT number
- NCT05289856
- EU CT number
- 2024-513518-37-00
- EudraCT number
- 2021-000986-34
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 30
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Pregnancy or lactation
- Typical or Atypical Carcinoid of the lung with a Ki67 < 20%
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Completed |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.