Avelumab in G2-3 NET (NCT03278379) | Clinical Trial Compass
CompletedPhase 2
Avelumab in G2-3 NET
Canada17 participantsStarted 2017-11-15
Plain-language summary
This is a single-center, single-arm, open-label, phase II trial to evaluate the efficacy and safety of avelumab in subjects with unresectable or metastatic, Grade 2-3, well-differentiated neuroendocrine.tumour.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Adults (males or females), aged 18 years or older with pathologically confirmed, advanced (unresectable or metastatic) neuroendocrine tumour from a gastroenteropancreatic or lung source. Both participants with functional NETs and those with nonfunctional NETs shall be eligible for this study.
* Histologically confirmed, WHO Grade 2-3, well-differentiated NETs of gastroenteropancreatic or lung origin.
* Has received 0,1 or 2 prior lines of systemic therapy (chemotherapy, PRRT, targeted therapies such as everolimus or sunitinib). Somatostatin analogues are not considered a line of therapy for the purposes of this criterion.
* Radiological documentation of disease progression within 24 weeks of study enrolment. Disease progression must be demonstrated on two scans less than one year apart.
* Participants previously treated with any systemic therapies are eligible to enroll if disease progression is documented during or after their last treatment.
* Measurable disease as assessed by CT scan of the chest, abdomen and pelvis which is suitable for accurate repeated measurements (according to RECIST v1.1).
* ECOG performance status 0-2.
* Adequate bone marrow function (ANC \> 1.5 x 109/L; Platelets \>100 x109/L; haemoglobin \> 90 g9/L).
* Adequate liver function defined by a total bilirubin level ≤1.5xULN and AST and ALT levels ≤2.5xULN for participants (or AST and ALT levels ≤ 5xULN for participants with documented metastatic disease to the liver).
* Adequa…