This is a prospective, multi-centre, open label, non-randomized phase II study evaluating the efficacy and safety of nivolumab plus platinum-based chemotherapy in patients with advanced G3 NENs of the GEP tract or of UK origin.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Subjects will receive Nivolumab 360 mg every 3 weeks (Q3W) first day of each cycle plus Carboplatin area under the curve (AUC5) Q3W first day of each cycle plus Etoposide 100 day 1-3 of each cycle up to 6 cycles of combined therapy (Induction Phase). At the time of completion of 6 cycles of chemotherapy and nivolumab, participants who have not experienced disease progression will continue to receive nivolumab at a dose of 480 mg as 30 minute infusion every 4 weeks for up to 2 years (24 months) (maintenance phase). Cycles are defined by 4 weeks or 28 days.
Subjects will receive Nivolumab 360 mg every 3 weeks (Q3W) first day of each cycle plus Carboplatin AUC5 Q3W first day of each cycle plus Etoposide 100 day 1-3 of each cycle up to 6 cycles of combined therapy (Induction Phase). At the time of completion of 6 cycles of chemotherapy and nivolumab, participants who have not experienced disease progression will continue to receive nivolumab at a dose of 480 mg as 30 minute infusion every 4 weeks for up to 2 years (24 months) (maintenance phase). Cycles are defined by 4 weeks or 28 days.
Subjects will receive Nivolumab 360 mg every 3 weeks (Q3W) first day of each cycle plus Carboplatin AUC5 Q3W first day of each cycle plus Etoposide 100 day 1-3 of each cycle up to 6 cycles of combined therapy (Induction Phase). At the time of completion of 6 cycles of chemotherapy and nivolumab, participants who have not experienced disease progression will continue to receive nivolumab at a dose of 480 mg as 30 minute infusion every 4 weeks for up to 2 years (24 months) (maintenance phase). Cycles are defined by 4 weeks or 28 days.
Institut Català d'Oncologia Badalona
Badalona, Barcelona, Spain
Institut Català d'Oncologia l'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Vall d'Hebron University Hospital
Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
MD Anderson Cancer Madrid
Madrid, Spain
Hospital Clínico Universitario Virgen de la Victoria
Málaga, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Spain
...and 2 more locations
Overall Survival Rate at 12 Months
Percentage of patients alive at 1-year from first dose of treatment.
Time frame: 12 months
Overall Response Rate (ORR)
Response to treatment according to RECIST 1.1 criteria or iRECIST 1.1 criteria assessed by computed tomography (CT) scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Throughout the study period, approximately 24 months
Progression-free Survival (PFS) Rate
Percentage of patients without progression of disease (PD) calculated from the date of treatment initiation with first-line chemotherapy and nivolumab until the date of first documentation of PD as per RECIST v1.1 or death.
Time frame: Throughout the study period, approximately 24 months
Median Overall Survival
Length of time between start of treatment and death
Time frame: 30 months
Predictive Biomarkers
Assess biochemical response in patients with baseline elevation of enolase and correlate it with clinical outcome.
Time frame: 30 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Number and type of adverse events reported throughout the study period according to CTCAE 5.0 criteria.
Time frame: 30 months
Median Progression-free Survival
Length of time between date of evidenced response and progression of disease or death
Time frame: 30 months
Duration of Response
The percentage of patients achieving Complete Response, Partial Response or stable disease (SD)
Time frame: 30 months
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