Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Infections

Symptoms and General Pathology

Rare Diseases

Carcinoma

Carcinoma, Neuroendocrine

Skin Neoplasms

Carcinoma, Merkel Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Adenocarcinoma

Neoplasms, Nerve Tissue

Communicable Diseases

Polyomavirus Infections

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Skin Diseases

Merkel Cell Carcinoma

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Lenvatinib

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Participants with Merkel cell carcinoma amenable to complete resection will receive two cycles (6 weeks) of therapy with the combination of lenvatinib plus pembrolizumab and then proceed to planned resection within 2-4 weeks following completion of cycle 2. Following surgical recovery and completion of adjuvant radiation therapy (if indicated), treatment will resume with pembrolizumab monotherapy with intent to complete 17 cycles total of pembrolizumab.

20mg of Lenvatinib will be taken orally once daily

Lenvatinib Oral Product

200mg of Pembrolizumab will be administered through IV infusion every 3 weeks.

Andrew Brohl, MD

Justin Martin

Nikhil Khushalani, MD

Zeynep Eroglu, MD

Ahmad Tarhini, MD

Vernon Sondak, MD

Youngchul Kim, PhD

Ken Tsai, PhD

This is a single arm trial of participants with Merkel cell carcinoma receiving a combination of lenvatinib plus pembrolizumab.

Neoadjuvant Lenvatinib Plus Pembrolizumab in Merkel Cell Carcinoma

Neoadjuvant Lenvatinib Plus Pembrolizumab in Resectable Merkel Cell Carcinoma

Pathological Complete Response will be determined by pathologist examination of tissue after neoadjuvant treatment and resection

Progressive disease will be defined by the detection of any recurrent disease following complete surgical resection or by progression of disease that is not amenable to complete surgical resection prior to planned surgery.

Feasibility of treatment will be defined by the percentage of patients able to complete both neoadjuvant cycles of trial therapy and be able to complete surgical resection as planned.

Merck Sharp & Dohme LLC

H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for trabecular carcinoma of the skin