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

Phase 2 Completed 37 enrolled Spanish Group for Research in Neuroendocrine Tumors

NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2019-10-11
Primary completion: 2023-02-13
Completion: 2023-06-09

Outcome

Missed primary endpoint

paper with a 12-month OS rate of 54.1% (95%CI: 40.2-72.8) that did not meet the primary endpoint. PMID 39117670 ↗

Publications

Riesco-Martinez MC, Capdevila J, Alonso V, Jimenez-Fonseca P, Teule A, Grande E, Sevilla I, Benavent M, Alonso-Gordoa T, Custodio A, Anton-Pascual B, Hernando J, Polo E, Castillo-Trujillo OA, Lamas-Paz A, Teijo A, Rodriguez-Gil Y, Soldevilla B, Garcia-Carbonero R. Nivolumab plus platinum-doublet chemotherapy in treatment-naive patients with advanced grade 3 Neuroendocrine Neoplasms of gastroenteropancreatic or unknown origin: The multicenter phase 2 NICE-NEC trial (GETNE-T1913). Nat Commun. 2024 Aug 8;15(1):6753. doi: 10.1038/s41467-024-50969-8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	5 unknown	Intravenous
Subject	Etoposide	Small molecule	100 mg/m2	Intravenous
Subject	Nivolumab	Monoclonal antibody	480 mg	Intravenous