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Cabozantinib in combination with Avelumab in patients refractory to standard chemotherapy with advanced neuroendocrine neoplasias G3 (NEN G3)
EU CTIS ID: 2024-513518-37-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.