Neoplasms

All Conditions

Rare Diseases

Carcinoma

Neuroendocrine Tumors

Carcinoma, Neuroendocrine

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Lenvatinib

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks, in addition to 20 mg Lenvatinib by mouth every day of each 3 week cycle. Estimated average length of treatment per participant: 4 months.

200 mg Pembrolizumab by IV on Day 1 of each 3 week cycle.

20 mg Lenvatinib by mouth every day of each 3 week cycle

Jonathan Strosberg, M.D.

The purpose of this study is to:

* Assess overall radiographic response rate (ORR)
* Assess progression-free survival (PFS)
* Test the safety and tolerability of Pembrolizumab in combination with lenvatinib

Phase II Study of Pembrolizumab and Lenvatinib in Advanced Well-differentiated Neuroendocrine Tumors

Response Evaluation Criteria in Solid Tumors (RECIST) based response rate. Complete Response (CR): Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to \<10 mm in short axis. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest). The SLD must also demonstrate an absolute increase of at least 5mm. (Two lesions increasing from 2 mm to 3 mm, for example, does not qualify). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

DOR, defined as the time from first documented evidence of Complete Response (CR) or Partial Response (PR) until disease progression or death due to any cause, whichever occurs first.

PFS, defined as the time from initial treatment to the first documented disease progression according to RECIST 1.1, or death due to any cause, whichever occurs first.

OS defined as the time from initial treatment until death from any cause.

Merck Sharp & Dohme LLC

H. Lee Moffitt Cancer Center and Research Institute

Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks, in addition to 20 mg Lenvatinib by mouth every day of each 3 week cycle. Estimated average length of treatment per participant: 4 months.

Pembrolizumab: 200 mg Pembrolizumab by IV on Day 1 of each 3 week cycle.

Lenvatinib: 20 mg Lenvatinib by mouth every day of each 3 week cycle

Spots Global Cancer Trial Database for Phase II Study of Pembrolizumab and Lenvatinib in Advanced Well-differentiated Neuroendocrine Tumors

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

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Contact Details

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