Trial intelligence / Profile preview

NICE-NEC: Nivolumab + Chemo in G3 GEP-NENs

NCT03980925Phase 2

Key facts

Status: Completed
Start: Oct 2019
Primary completion: Feb 2023
Countries: 1
Sponsor: Spanish Group of Neuroendocrine Tumors
Modality: Monoclonal Antibodies

Drugs: nivolumab
Conditions: Gastroenteropancreatic Neuroendocrine Neoplasm (GEP-NEN)Neuroendocrine neoplasm (NEN)

Overview

Phase 2, open-label, single-arm trial of nivolumab in Gastroenteropancreatic Neuroendocrine Neoplasm (GEP-NEN) and Neuroendocrine neoplasm (NEN), sponsored by Spanish Group of Neuroendocrine Tumors. Primary endpoint: Overall Survival Rate at 12 Months. Started Oct 2019; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Nivolumab + platinum-doublet chemotherapy
Induction with Nivolumab + Carboplatin + Etoposide followed by Nivolumab maintenance

Who it enrols

Adult patients with confirmed G3 NENs of GEP or unknown origin, Ki-67 >20%, no prior systemic treatment for advanced disease, and adequate organ function.

Endpoints

Primary

Overall Survival Rate at 12 Months12 months

Secondary

Overall Response Rate24 months
Progression-free Survival Rate24 months
Median Overall Survival30 months
Predictive Biomarkers30 months
Incidence of Treatment-Emergent Adverse Events30 months
Median Progression-free Survival30 months
Duration of Response30 months

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