ENFORTUMAB VEDOTIN for Neuroendocrine carcinoma (NEC) | Neuroendocrine tumour, grade 3 (NET G3)

Inclusion criteria

• {"criterion_text":"- Patients 18 years of age or older."}
• {"criterion_text":"- Patients who give informed consent to participate in the study."}
• {"criterion_text":"- Patients with histologically documented poorly-differentiated neuroendocrine carcinoma of any origin, excluding the lung, or histologically documented well-differentiated neuroendocrine tumours of grade 3 histology with a Ki-67 index >20%, of any origin, excluding the lung, who have failed at least one prior line of platinum-based systemic therapy or are considered ineligible for platinum-based chemotherapy"}
• {"criterion_text":"- Patients with radiologically documented metastatic or locally advanced disease at the start of the study. Subjects with brain metastases must have clinically controlled neurological symptoms and must have completed radiotherapy at least 21 days prior to administration of the first dose of study drug."}
• {"criterion_text":"- Patients with ECOG score 0-2."}
• {"criterion_text":"- Evaluable and/or measurable disease by CT scan according to RECIST v1.1."}
• {"criterion_text":"- Patients must have adequate renal and hepatic function according to the local laboratory reference ranges at the time of screening: - Absolute neutrophil count ≥ 1500/µcL - Platelets ≥ 80,000/mm3 - Haemoglobin ≥ 9.0 g/dL - Serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 30 mL/min - Sodium > 130 mmol/L - Alkaline phosphatase, AST and ALT ≤ 2.5 x ULN - Bilirubin ≤ 1.5 x ULN - Patients with liver metastases may have ALP, AST and ALT ≤ 5.0 x ULN - Patients with bone metastases may have alkaline phosphatase ≤ 5.0 x ULN - Patients with Gilbert’s syndrome may have bilirubin > 1.5 x ULN - Coagulation: activated partial thromboplastin time (aPTT), prothrombin time (PT) ≤ 1.2 x ULN."}
• {"criterion_text":"- Life expectancy of at least 12 weeks."}
• {"criterion_text":"- Women must be surgically sterile, post-menopausal (for at least 1 year), or have a negative pregnancy test."}
• {"criterion_text":"- Women who are not surgically sterile or post-menopausal (for at least one year) and men who have not had a vasectomy must use highly effective contraception measures. (Please see section 13.3.8 of protocol for further details)."}

Exclusion criteria

• {"criterion_text":"- Prior systemic treatment with any antimicrotubule agent such as taxanes or Enfortumab Vedotin, or more than two lines of chemotherapy-based systemic therapy, excluding adjuvant or neoadjuvant treatments."}
• {"criterion_text":"- Grade 2 or higher peripheral neuropathy."}
• {"criterion_text":"- Patients with evidence of other severe uncontrolled disease as judged by the investigator."}
• {"criterion_text":"- Patients with active immune thrombocytopenic purpura, autoimmune haemolytic anaemia, or a history of being refractory to platelet transfusions (within 1 year prior to the 1st dose of study drug)."}
• {"criterion_text":"- Patients with a significant history of uncontrolled cardiovascular disease or renal, neurological, psychiatric, endocrine, metabolic, immunological, or hepatic disease."}
• {"criterion_text":"- Women who are pregnant or breastfeeding."}
• {"criterion_text":"- Patients with a history of other active malignancies within three years prior to study start, with the exception of: adequately treated carcinoma in situ of the cervix, basal or squamous cell carcinoma of the skin, or prior confined malignancy surgically resected with curative intent."}
• {"criterion_text":"- Patients having received any anticancer therapy within 14 days prior to the first dose of study drug."}
• {"criterion_text":"- Patients undergoing major surgery in the four weeks prior to the first dose of study drug."}
• {"criterion_text":"- Patients with known hypersensitivity to EV or any excipient contained in the EV pharmaceutical formulation (including histidine, trehalose dihydrate, and polysorbate 20)."}
• {"criterion_text":"- Patients with poorly controlled diabetes (glycated haemoglobin ≥ 10%)."}

Primary endpoints

• {"endpoint_text":"- Objective response rate (ORR) according to RECIST v1.1.","definition_or_measurement_approach":"ORR assessed according to RECIST v1.1 (radiological objective response rate)."}

Secondary endpoints

• {"endpoint_text":"- Progression-free survival (PFS): The time from the start of the first dose of the study treatment to the first objective documentation of tumour progression or death from any cause.","definition_or_measurement_approach":"Time from first dose to objective tumour progression or death; assessed per RECIST v1.1."}
• {"endpoint_text":"- Duration of response (DOR): The time from the first documentation of confirmed objective response (CR or PR) to the first objective documentation of tumour progression or death due to any reason.","definition_or_measurement_approach":"Time from first confirmed CR or PR to tumour progression or death."}
• {"endpoint_text":"- Overall survival (OS): The time from the start of the first dose of the study treatment to death due to any reason.","definition_or_measurement_approach":"Time from first dose to death from any cause."}
• {"endpoint_text":"- Absolute and relative frequencies of patients experiencing adverse events (AEs), patients experiencing serious adverse events (SAEs), patients experiencing adverse reactions (ARs), patients experiencing serious adverse reactions (SARs) and patients experiencing suspected unexpected serious adverse reactions (SUSARs). Absolute frequencies of recorded AEs, recorded SAEs, recorded ARs, recorded SARs and recorded SUSARs.","definition_or_measurement_approach":"Safety/tolerability assessed by counts and frequencies of AEs, SAEs, ARs, SARs, SUSARs as recorded during the study."}
• {"endpoint_text":"- Exploratory variables: Expression levels of nectin-4 determined by immunohistochemistry in the tumour block of the diagnostic biopsy.","definition_or_measurement_approach":"Expression of nectin-4 measured by immunohistochemistry on tumour biopsy specimens; exploratory correlation with clinical outcomes."}

Other endpoints

• {"endpoint_text":"- Exploratory variables: Expression levels of nectin-4 determined by immunohistochemistry in the tumour block of the diagnostic biopsy.","definition_or_measurement_approach":"Immunohistochemistry measurement of nectin-4 expression in diagnostic tumour block; translational correlation analyses with clinical outcomes."}

Spain

Earliest CTIS Part Ii Submission Date

08-01-2025

Latest Decision Or Authorization Date

29-10-2025

Processing Time Days

294

Number Of Sites

10

Number Of Participants

63

Primary sponsor

Full Name

Grupo Espanol De Tumores Neuroendocrinos

Organisation Type

Patient organisation/association

Country Of Registered Address

Spain

Third parties

• {"country":"Spain","full_name":"Adknoma Health Research S.L.","duties_or_roles":"1,10,11,12,14,5,6,7,8","organisation_type":"Pharmaceutical company"}