Platinum-doublet chemotherapy combined with nivolumab as first treatment for unresectable, locally advanced or metastatic neuroendocrine neoplasms of the stomach, intestines or pancreas or of unknown origin.

A phase II study of Platinum-doublet chemotherapy in combination with nivolumab as first-line treatment, in subjects with unresectable, locally advanced or metastatic G3 Neuroendocrine Neoplasms (NENs) of the gastroenteropancreatic (GEP) tract or of unknown (UK) origin. - NICE-NEC

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001546-18-ES

Enrollment

Registered

2019-06-11

Start date

2019-08-19

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable, locally advanced or metastatic G3 Neuroendocrine Neoplasms (NENs) of the gastroenteropancreatic (GEP) tract or of unknown (UK) origin. MedDRA version: 20.1 Level: PT Classification code 10067517 Term: Pancreatic neuroendocrine tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT

Interventions

Trade Name: OPDIVO Product Name: OPDIVO Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: NIVOLUMAB CAS Number:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Histologically confirmed G3 NENs originated in the gastroenteropancreatic tract (WHO 2015/2019 classification). Patients with a G3 NEN of unknown primary will also be eligible for this trial. - Ki-67 >20% or mitotic rate > 20 per 10 HPF. - Metastatic or locally advanced unresectable disease not amenable to treatment with curative intent. - No prior systemic treatment for advanced disease nor as adjuvant therapy permitted. - Availability of fresh or archive formalin-fixed, paraffin-embedded tumor tissue for biomarker assessment. - Patients must have clinically and/or radiographically documented measurable disease. - Adequate organ function as defined by the following criteria absolute neutrophil count (ANC) =1500 cells/mm3; platelets =100,000 cells/mm3; hemoglobin =9.0 g/dL; AST and 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. - ECOG performance status of 0-2. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 38 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 38

Exclusion criteria

Exclusion criteria: - The following endocrine tumor types may not be included: paraganglioma, adrenal, thyroid parathyroid or pituitary endocrine tumors. Large or small cell lung neuroendocrine carcinoma of the lung will also be excluded. - Prior therapy with any immune checkpoint inhibitor. - Prior organ transplantation, including allogeneic stem-cell transplantation. - Systemic chronic steroid therapy (> 10 mg/day prednisone or equivalent) or other immunosuppressive agents or use of any investigational drug within 28 days before the start of trial treatment. - Known history of positive testing for Human Immunodeficiency Virus (HIV) infection, known history of positive tests for Hepatitis B virus surface antigen (HBVsAg) or Hepatitis C ribonucleic acid (HCV RNA) indicating acute or chronic infection or other significant acute or chronic infections requiring medication at study entry.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the overall survival patients with advanced G3 NENs treated with nivolumab + platinum-based chemotherapy.; Secondary Objective: - To determine other efficacy outcomes of nivolumab + platinum-based chemotherapy in patients with advanced G3 NENs. - To evaluate the safety and tolerability of nivolumab + platinum-based chemotherapy in this patient population. - To evaluate biochemical response as predictive biomarker of efficacy of nivolumab + chemotherapy in this patient population. - To explore potential predictive and prognostic biomarkers. ;Primary end point(s): Overal survival rate;Timepoint(s) of evaluation of this end point: 1 year after start of treatment	—

Measure

Time frame

Main Objective: To determine the overall survival patients with advanced G3 NENs treated with nivolumab + platinum-based chemotherapy.; Secondary Objective: - To determine other efficacy outcomes of nivolumab + platinum-based chemotherapy in patients with advanced G3 NENs. - To evaluate the safety and tolerability of nivolumab + platinum-based chemotherapy in this patient population. - To evaluate biochemical response as predictive biomarker of efficacy of nivolumab + chemotherapy in this patient population. - To explore potential predictive and prognostic biomarkers. ;Primary end point(s): Overal survival rate;Timepoint(s) of evaluation of this end point: 1 year after start of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): - Overall response rate (ORR) - Duration of response (DoR) - Progression-free survival (PFS) - Overall survival (OS) - Incidence of adverse events (AEs), severe AEs and selected AEs. - Chromogranin A and enolase values and their association with ORR, PFS and OS. - Mutational burden, gene expression signature, soluble factors and other molecular markers in peripheral blood and their association with clinical outcomes. - ;Timepoint(s) of evaluation of this end point: End of follow up	—

Measure

Time frame

Secondary end point(s): - Overall response rate (ORR) - Duration of response (DoR) - Progression-free survival (PFS) - Overall survival (OS) - Incidence of adverse events (AEs), severe AEs and selected AEs. - Chromogranin A and enolase values and their association with ORR, PFS and OS. - Mutational burden, gene expression signature, soluble factors and other molecular markers in peripheral blood and their association with clinical outcomes. - ;Timepoint(s) of evaluation of this end point: End of follow up

—

Countries

Spain

Contacts

Public ContactFederico Nepote

MFAR Clinical Research

investigacion@mfar.net3493 434 44 12

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026