CompletedPhase 2

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

Spain37 participantsStarted 2019-10-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. absolute neutrophil count (ANC) ≥1500 cells/mm3
✓. platelets ≥100,000 cells/mm3
✓. hemoglobin ≥9.0 g/dL
✓. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x upper limit of normal (ULN); in patients with liver metastases AST and ALT ≤5.0 x ULN
✓. total bilirubin ≤1.5 x ULN
✓. serum creatinine ≤1.5 x ULN or calculated creatinine clearance ≥60 mL/min.

What they're measuring

Overall Survival Rate at 12 Months

Timeframe: 12 months

Trial details

NCT IDNCT03980925

SponsorGrupo Espanol de Tumores Neuroendocrinos

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-13

Results submitted2024-10-02

View on ClinicalTrials.gov More Neuroendocrine Tumors trials