A phase II single arm trial evaluating the preliminary efficacy of the combination of 177Lu-DOTATATE and nivolumab in Grade 3 well-differentiated neuroendocrine tumours (NET) or poorly differentiated neuroendocrine carcinomas (NEC)

Fundación de investigación de HM Hospitales0 sites30 target enrollmentDecember 2, 2019

Conditionseuroendocrine neoplasms (Grade 3 well-differentiated neuroendocrine tumours (NET) or poorly differentiated neuroendocrine carcinomas (NEC))MedDRA version: 20.0 Level: PT Classification code 10057270 Term: Neuroendocrine carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0 Level: PT Classification code 10052399 Term: Neuroendocrine tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0 Level: LLT Classification code 10062476 Term: Neuroendocrine tumor System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsOPDIVO 10 mg/ml concentrado para solución para perfusión Lutathera 370 MBq/ml solución para perfusión

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: euroendocrine neoplasms (Grade 3 well-differentiated neuroendocrine tumours (NET) or poorly differentiated neuroendocrine carcinomas (NEC))
Sponsor: Fundación de investigación de HM Hospitales
Enrollment: 30
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 2, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Fundación de investigación de HM Hospitales

Eligibility Criteria

Inclusion Criteria

•1\)Patients having voluntarily signed and dated an and dated an IRB/IEC\-approved written informed consent form in accordance with regulatory and institutional guidelines before the performance of any protocol\-related procedures.
•2\)Patients with advanced/metastatic, histologically confirmed, well\-differentiated grade Grade 3 NET or poorly\-differentiated NEC of the pancreas, gastrointestinal tract and unknown primary site at diagnosis or after progression to one systemic treatment. Patients will be enrolled in two cohorts based on the therapy of their aforementioned cancer:
•Cohort 1: Patients with no previous chemotherapy.
•Cohort 2: Patients who have received one line of chemotherapy.
•3\)Age \> or \=18 years.
•4\)Patients must have measurable disease based on RECIST v.1\.1 meeting the following criteria:
•a)Lesions that have had external beam radiotherapy or loco\-regional therapies such as radiofrequency ablation or liver embolization must show evidence of progressive disease based on RECIST v.1\.1 to be deemed a target lesion.
•b)Patients in cohort 2 must show evidence of disease progression by radiologic image techniques according to RECIST v.1\.1 within 3 months prior to signing informed consent.
•5\)Confirmed presence of somatostatin receptors on tumour lesions based on positive PET\-Gallium (SomaKit) imaging within 8 weeks prior to enrolment in the study. At least one lesion should have an uptake of 64\-Gallium higher than the normal liver according to investigator judgement.
•6\)Karnofsky Performance Score \> or \= 60 and Eastern Cooperative Oncology Group (ECOG) performance status (PS) \< or \= 2\.

Exclusion Criteria

•1\)Lung neuroendocrine tumours, carcinomas or carcinoids.
•2\)Treatment with \>30 mg Octreotide LAR at 3\-4 weeks intervals within 12 weeks prior to enrolment in the study.
•3\)Peptide receptor radionuclide therapy (PRRT) at any time prior to enrolment in the study.
•4\)Targeted surgery, radiotherapy (external beam), chemotherapy, embolization, interferons, mTOR\-inhibitors or other investigational therapy within 12 weeks prior to enrolment in the study. In Cohort 2, chemotherapy should be administered at least 4 weeks prior to first dose of the treatment.
•5\)Prior treatment with anti\-PDL\-1/anti\-PD\-1 or anti\-CTL\-4 therapy.
•6\)Known brain metastases, unless these metastases have been treated and stabilized for at least 24 weeks prior to enrolment in the study. Patients with a history of brain metastases must have a head CT with contrast to document stable disease prior to enrolment in the study.
•7\)Uncontrolled congestive heart failure (NYHA II\-IV).
•8\)Uncontrolled diabetes mellitus as defined by a fasting blood glucose \>2 ULN.
•9\)Any patient receiving treatment with short\-acting Octreotide, which cannot be interrupted for 24 h before and 24 h after the administration of 177Lu\-DOTATATE , or any patient receiving treatment with Octreotide LAR, which cannot be interrupted for at least 6 weeks before the administration of 177Lu\-DOTATATE, unless the tumour uptake observed by Somakit imaging during continued Octreotide treatment is at least as high as normal liver uptake observed by planar imaging.
•10\) Acute or chronic hepatitis B (e.g., Hepatitis B surface antigen reactive), hepatitis C (e.g., HCV RNA \[qualitative] is detected) or known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).