Platinum-doublet Chemotherapy and Nivolumab for the Treatment of Subjects With Neuroendocrine Neoplasms (NENs) of the Gastroenteropancreatic (GEP) Tract or of Unknown (UK) Origin.

PHASE2CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

October 11, 2019

Primary Completion Date

February 13, 2023

Study Completion Date

June 9, 2023

Conditions
Neuroendocrine TumorsNeuroendocrine NeoplasmGastroenteropancreatic Neuroendocrine Tumor
Interventions
DRUG

Nivolumab

"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."

DRUG

Carboplatin

"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."

DRUG

Etoposide

"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."

Trial Locations (12)

Unknown

Institut Català d'Oncologia Badalona, Badalona

Institut Català d'Oncologia l'Hospitalet, L'Hospitalet de Llobregat

Vall d'Hebron University Hospital, Barcelona

Hospital Universitario 12 de Octubre, Madrid

Hospital Universitario La Paz, Madrid

Hospital Universitario Ramón y Cajal, Madrid

MD Anderson Cancer Madrid, Madrid

Hospital Clínico Universitario Virgen de la Victoria, Málaga

Hospital Universitario Central de Asturias, Oviedo

Hospital Universitario Marqués de Valdecilla, Santander

Hospital Universitario Virgen del Rocío, Seville

Hospital Universitario Miguel Servet, Zaragoza

All Listed Sponsors
lead

Grupo Espanol de Tumores Neuroendocrinos

OTHER

NCT03980925 - Platinum-doublet Chemotherapy and Nivolumab for the Treatment of Subjects With Neuroendocrine Neoplasms (NENs) of the Gastroenteropancreatic (GEP) Tract or of Unknown (UK) Origin. | Biotech Hunter | Biotech Hunter