NCT04323202

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

A Phase 1B, Single Arm Study of Neoadjuvant-Adjuvant Pembrolizumab in Resectable Advanced Basal Cell Carcinoma of the Head and Neck to Assess for Pathologic Responses in the Tumor Microenvironment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Basal Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Post Fine-cut CT: 4 doses of pembrolizumab (200mg) IV q 3 weeks. Post standard resection and reconstruction: 1 year of pembrolizumab (200mg) q 3 weeks (another 13 doses, thus 17 doses total)
OTHER	Tissue collection	Non-marginal tissue as well as pre-op biopsy tissue to be stored

Timeline

• Start date: 2020-08-04
• Primary completion: 2024-07-23
• Completion: 2025-06-25
• First posted: 2020-03-26
• Last updated: 2025-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study