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.

Phase 1

• Conditions: nresectable, 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 Classification code 10067518 Term: Pancreatic neuroendocrine tumor System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10068909 Term: Pancreatic neuroendocrine tumour metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: LLT Classification code 10068916 Term: Pancreatic neuroendocrine tumor metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10071542 Term: Neuroendocrine carcinoma metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10077559 Term: Gastroenteropancreatic neuroendocrine tumour disease System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA ve; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-001546-18-ES
• Lead Sponsor: Grupo Español de Tumores Neuroendocrinos y Endocrinos (GETNE)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-11
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 38

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified