An open label phase II study to evaluate the efficacy and safety of PDR001 in patients with well-differentiated advanced or metastatic non-functional neuroendocrine tumors of pancreatic, gastrointestinal (GI), or thoracic origin or poorly-differentiated gasteroenteropancreatic neuroendocrine carcinoma (GEP-NEC) who have progressed on prior treatment (CPDR001E2201)
- Conditions
- 10029107Neuroendocrin tumours of GIpancreas and thorax origin1001799010014713
- Registration Number
- NL-OMON46949
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4
* Female and male patients * 18 years old.
* Pathologically confirmed, advanced (unresectable or metastatic):
- well-differentiated (G1 or G2) unresectable or metastatic non-functional neuroendocrine tumor of GI, pancreatic or thoracic (including lung and thymus) origin.
- poorly differentiated GEP-NEC based on local pathology report
* No active symptoms related to carcinoid syndrome during the last 3 months prior to start
* Criteria for the 4 cohorts (based on location of primary tumor): see protocol, page 35.
* Radiological documentation of disease progression while on/or after the last treatment, see protocol page 35/36 for details.
* At least one measurable lesion assessed by CT and/or MRI according to RECIST 1.1.
* ECOG performance status 0-1-2.
* Adequate contraception.
* Tumor biopsy material mist be provided for all patients for the purpose of biomarker analysis:
- well-differentiated (G1/2) NET: collected from the metastic site, not previously irradiated, preferably be taken within 6 months but not more than 24 months prior start study treatment
- poorly differentiated GEP-NEC: collected from the primary tumor of from metastartic site, not previously irradiated, taken not more tha 24 months prior start study treatment
Update Am2:
- life expectancy of at least 3 months
* Well differentiated grade 3 neuro-endocrine tumors; poorly differentiated neuro-endocrine carcinoma of any origin (other than GEP-NEC); including NEC of unknown origin, adenocarcinoid, goblet cell carcinoid, large cell neuro-endocrine carcinoma and small cell carcinoma.
* Pretreatment with interferon as last treatment prior to start of study treatment.
* Prior treatment for study indication with antibodies or immunotherapy, PRRT, systemische antineoplastic therapy, TKIs, PD-1 or PD-L1 directed therapy. Cryoablation, radiofrequency ablation, or trans-arterial chemo-embolization of hepatic metastases. See for details and washout periods protocol page 37.
* History of severe hypersensitivity reactions to other monoclonal antibodies which in the opinion of the investigator may pose an increased risk of a serious infusion reaction.
* Pregnancy, lactation, insufficient contraception for females of childbearing potential.
* Autoimmune disease that has required systemic treatment. Stable and adequate controlled endocrinopathies requiering replacement therapy are not considered as systemic treatment and therefore are allowed.
* Known history or current interstitial lung disease or nonb-infections pneumonitis
* Use of somatostatin analogs or any other medications administered to control active symtoms related to carcinoid syndrome during the last 3 months prior to start of study treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Overall response rate.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Duration of response. Adverse events, additional efficacy parameters per<br /><br>Resist, CgA and NSE, PK parameters, quality of life, immunogenicity.</p><br>