Neoadjuvant-Adjuvant Pembrolizumab in Resectable Advanced Basal Cell Carcinoma of H&N

2020-04-01 04:26:53 | BioPortfolio


The purpose of this study is to evaluate anti-PD-1 Neoadjuvant therapy in Basal cell carcinoma to provide a better outcome when administered prior to surgery and provide a therapeutic strategy to avoid surgery altogether. The study team will gather information about how Basal cell carcinoma responds to Pembrolizumab prior to surgery and to gather information about recurrence rates.

Pembrolizumab, is an investigational (experimental) drug that may improve the response of the immune system against cancer. Pembrolizumab is a manufactured antibody, much like the antibodies usually made by the human body to fight off infection. The idea behind developing this experimental drug is to stimulate the body's immune system to kill cancer cells. Pembrolizumab antibody has been specifically made to block a program cell death-1 (PD-1) protein receptor, which is found on cells of the immune system. PD-1 receptor seems to slow down the immune response. Blocking PD-1 with pembrolizumab antibody may make the immune response more active and may improve the response of the immune system against cancer. Pembrolizumab is currently FDA approved for use in other malignancies. It has been used to treat a number of other diseases such as certain types of lung cancer, cervical cancer and lymphoma. The use of Pembrolizumab in this study is experimental because it is not approved by the Food and Drug Administration (FDA) for use in the treatment of Basal cell carcinoma.


This is a phase 1 study looking at anti-PD-1 Neoadjuvant therapy in Basal cell carcinoma in participants with locoregionally advanced, but resectable basal cell carcinoma of the head and neck. Participants will undergo fine cut CT imaging (head and neck) and treatment with the study drug pembrolizumab.

The primary objective of this study is to evaluate pathologic response to pre-operative treatment of pembrolizumab in the study group.

Secondary objectives of this study include assessing safety of the intervention, and assessing phenotyping immune infiltrates in non-pathology complete responders (pCRs), as well as assessment of changes to the systemic immune system (e.g. peripheral blood lymphocytes (PBLs)) in pCRs vs partial responders (pPR) vs non responders.

The exploratory objective will include assessing one-year recurrence rates after completion of NeoAdjuvant-Adjuvant therapy.

Study Design


Basal Cell Carcinoma of the Head and Neck


Pembrolizumab, Tissue collection


Cleveland Clinic, Case Comprehensive Cancer Center
United States


Not yet recruiting


Case Comprehensive Cancer Center

Results (where available)

View Results


Published on BioPortfolio: 2020-04-01T04:26:53-0400

Clinical Trials [6598 Associated Clinical Trials listed on BioPortfolio]

Neoadjuvant Pembrolizumab + Epacadostat Prior to Curative Surgical Care for Squamous Cell Carcinoma of the Head and Neck

The KEO study is a single arm phase II trial including 44 patients with T1N1-2B, T2N0-N2B head and neck squamous cell carcinoma (HNSCC) eligible for curative-intent resection (+/- adjuvant...

Afatinib and Pembrolizumab for Head and Neck Squamous Cell Carcinoma (ALPHA Study)

The primary objectives of the trial is to examine the toxicities and efficacies of afatinib and pembrolizumab for recurrent and/or metastatic head and neck squamous cell carcinoma.

A Study of Duvelisib in Combination With Pembrolizumab in Head and Neck Cancer

This study will assess the safety and preliminary efficacy of duvelisib in combination with pembrolizumab in subjects with recurrent or metastatic (R/M) head and neck squamous cell carcino...

AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma

This research is studying the safety and effectiveness of AMD3100 and pembrolizumab in participants with metastatic head and neck squamous cell carcinoma.

Efficacy Study of Pembrolizumab in Relapsed, Locally Recurrent Squamous Cell Cancer of the Head and Neck

The purpose of this study is to determine whether pembrolizumab, when given after salvage surgery, is effective in increasing the time a person with squamous cell cancer of the head and ne...

PubMed Articles [26269 Associated PubMed Articles listed on BioPortfolio]

Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study.

Pembrolizumab is active in head and neck squamous cell carcinoma (HNSCC), with programmed cell death ligand 1 (PD-L1) expression associated with improved response.

Comparative Analyses of Tumour Volume Doubling Times for Periocular and Non-periocular Head and Neck Basal Cell Carcinomas.

Basal cell carcinomas are the commonest solid malignancy in humans and thought to grow faster in the periocular region. We measured growth rates between periocular and non-periocular nodular basal cel...

Oncodermatology of the Head and Neck.

The European Academy of Facial Plastic Surgery celebrates its 40th anniversary. We aimed to describe innovations in the diagnostics and treatment in head and neck skin cancer over the past 40 years ...

Prognostic Value of Tumor-Infiltrating Lymphocytes in Head and Neck Squamous Cell Carcinoma.

Biomarkers that reflect prognosis and cellular immunity in patients with head and neck squamous cell carcinoma (HNSCC) are a prerequisite for improving individualized treatment that limits the intensi...

Evaluation of Tissue and Serum Expression Levels of Lactate Dehydrogenase Isoenzymes in Patients with Head and Neck Squamous Cell Carcinoma.

Head and Neck Squamous Cell Carcinoma (HNSCC) is a common malignancy that is associated with high morbidity and mortality all over the world. We explored the role of mRNA expression of both subunits o...

Medical and Biotech [MESH] Definitions

A carcinoma arising from MERKEL CELLS located in the basal layer of the epidermis and occurring most commonly as a primary neuroendocrine carcinoma of the skin. Merkel cells are tactile cells of neuroectodermal origin and histologically show neurosecretory granules. The skin of the head and neck are a common site of Merkel cell carcinoma, occurring generally in elderly patients. (Holland et al., Cancer Medicine, 3d ed, p1245)

A malignant skin neoplasm that seldom metastasizes but has potentialities for local invasion and destruction. Clinically it is divided into types: nodular, cicatricial, morphaic, and erythematoid (pagetoid). They develop on hair-bearing skin, most commonly on sun-exposed areas. Approximately 85% are found on the head and neck area and the remaining 15% on the trunk and limbs. (From DeVita Jr et al., Cancer: Principles & Practice of Oncology, 3d ed, p1471)

Dissection in the neck to remove all disease tissues including cervical LYMPH NODES and to leave an adequate margin of normal tissue. This type of surgery is usually used in tumors or cervical metastases in the head and neck. The prototype of neck dissection is the radical neck dissection described by Crile in 1906.

A surgical technique used primarily in the treatment of skin neoplasms, especially basal cell or squamous cell carcinoma of the skin. This procedure is a microscopically controlled excision of cutaneous tumors either after fixation in vivo or after freezing the tissue. Serial examinations of fresh tissue specimens are most frequently done.

An aggressive THYROID GLAND malignancy which generally occurs in IODINE-deficient areas in people with previous thyroid pathology such as GOITER. It is associated with CELL DEDIFFERENTIATION of THYROID CARCINOMA (e.g., FOLLICULAR THYROID CARCINOMA; PAPILLARY THYROID CANCER). Typical initial presentation is a rapidly growing neck mass which upon metastasis is associated with DYSPHAGIA; NECK PAIN; bone pain; DYSPNEA; and NEUROLOGIC DEFICITS.

More From BioPortfolio on "Neoadjuvant-Adjuvant Pembrolizumab in Resectable Advanced Basal Cell Carcinoma of H&N"

Quick Search

Relevant Topics

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...

Skin cancers
There are three main types of skin cancer: basal cell carcinoma, squamous cell carcinoma and malignant melanoma. Basal cell carcinoma Basal cell carcinoma, or BCC, is a cancer of the basal cells at the bottom of the epidermis. It’s very common ...

Searches Linking to this Trial