Neoplasms

All Conditions

Rare Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antibodies

Immunoglobulins

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Monotherapy with PD-1 antibody pembrolizumab

Pembrolizumab given intravenously at a fixed dose of 200mg every 3 weeks

Namrata Vijayvergia, MD

The purpose of this research study is to test if pembrolizumab is safe and effective for treating patients with metastatic high-grade neuroendocrine tumors who have failed platinum based chemotherapy.The study drug, pembrolizumab has been FDA approved for treating a type of skin cancer called melanoma and for metastatic non-small cell lung cancer. However, it is not approved for treatment of metastatic high-grade neuroendocrine tumors.

A Study of Pembrolizumab in Patients With Neuroendocrine Tumors

A Phase 2, Open-label Study of Pembrolizumab Monotherapy in Patients With Metastatic High Grade Neuroendocrine Tumors

To estimate objective response rate (ORR), using RECIST 1.1, in previously treated metastatic High Grade Neuroendocrine Tumors (HGNET) patients treated with pembrolizumab monotherapy. The Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria will be used for objective tumor response assessment: Complete Response (CR):Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters

To evaluate progression free survival (PFS) (using RECIST 1.1) in metastatic HGNET patients treated with pembrolizumab monotherapy. PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase (at least 5 mm absolute increase) in the sum of the longest diameter of target lesions. PFS was estimated according to the Kaplan-Meier method.

To evaluate overall survival (OS) in metastatic HGNET patients treated with pembrolizumab monotherapy. OS was estimated according to the Kaplan-Meier method.

Occurence of toxicity, graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.0.

Merck Sharp & Dohme LLC

Fox Chase Cancer Center

Monotherapy with PD-1 antibody pembrolizumab

Pembrolizumab: Pembrolizumab given intravenously at a fixed dose of 200mg every 3 weeks

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

United States

Region of Enrollment

Pembrolizumab can be safely administered to patients with G3NENs but has limited activity as a single agent. Further research to identify active combination therapies should be considered.

Namrata Vijayvergia

Analysis was completed using data from an external site which accrued 8 patients

Objective Response Rate (ORR)

Progression Free Survival (PFS)

Analysis was completed using data from an external site which accrued 8 patients. 95% confidence interval upper limit not estimated

Spots Global Cancer Trial Database for A Study of Pembrolizumab in Patients With Neuroendocrine Tumors

Trial Identification

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Study Description

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