Neoplasms

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Skin and Connective Tissue Diseases

Carcinoma

Carcinoma, Squamous Cell

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Skin Neoplasms

Neoplasms, Glandular and Epithelial

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Neoplasms, Squamous Cell

Skin Diseases

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Cemiplimab

Antineoplastic Agents, Immunological

Patients receive cemiplimab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles (or up to 4 cycles for patients whose disease is unresectable after 3 cycles) in the absence of disease progression or unacceptable toxicity. Within 6 weeks of last dose of therapy, patients with potentially resectable tumors undergo surgical resection.

Resection

Charlean Ketchens, RN

Charlean Ketchens

Gino K. In, MD

Cristina de Leon

Jacob S. Thomas, MD

Kavita Shah

Sunandana Chandra, MD

Gino K In, MD

This phase II trial studies how well cemiplimab before surgery works in treating patients with skin cancer that is high-risk and has not spread to other parts of the body (localized), has come back locally (locally recurrent), or has spread regionally (regionally advanced), and can be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

PRIMARY OBJECTIVE:

I. To assess the pathological partial response (PPR) rate in patients with potentially resectable cutaneous squamous cell carcinoma (CSCC) treated with neoadjuvant cemiplimab.

SECONDARY OBJECTIVES:

I. To estimate the pathological complete response rate (PCR). II. To estimate the Response Evaluation Criteria in Solid Tumors (RECIST) (version \[v\]1.1) 9 week objective response rate (ORR).

III. To estimate the RECIST (v1.1) 12 month progression free (PFS). IV. To assess the toxicity among patients with CSCC treated with neoadjuvant cemiplimab.

EXPLORATORY OBJECTIVES:

I. To evaluate tumor mutational burden (TMB) and correlate with response to PD-1 blockade therapy.

II. To evaluate PD-L1 expression on CSCC tumor cells and correlate with response to PD-1 blockade.

III. To evaluate CD8+ T cell infiltration into CSCC tumors and correlate with response to PD-1 blockade.

IV. To assess other adaptive immune resistance mechanisms in CSCC tumors.

OUTLINE:

Patients receive cemiplimab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles (or up to 4 cycles for patients whose disease is unresectable after 3 cycles) in the absence of disease progression or unacceptable toxicity. Within 6 weeks of last dose of therapy, patients with potentially resectable tumors undergo surgical resection.

After completion of study treatment, patients are followed up every 3 months for 24 months.

A PD-1 Checkpoint Inhibitor (Cemiplimab) for High-Risk Localized, Locally Recurrent, or Regionally Advanced Skin Cancer

Evaluating the PD-1 Checkpoint Inhibitor, Cemiplimab, as Neoadjuvant Therapy in High Risk Localized, Locally Recurrent, and Regionally Advanced Cutaneous Squamous Cell Carcinoma: A Phase II Pilot Study

Defined by presence of \< 50% malignant cells. Descriptive statistics will be used to summarize the measurements.

Descriptive statistics will be used to summarize the measurements.

Measured by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. Descriptive statistics will be used to summarize the measurements.

Measured by RECIST v1.1. Descriptive statistics will be used to summarize the measurements.

All toxicities will be summarized and graded according to maximum grade by Common Terminology Criteria for Adverse Events v4. Descriptive statistics will be used to summarize the measurements.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A PD-1 Checkpoint Inhibitor (Cemiplimab) for High-Risk Localized, Locally Recurrent, or Regionally Advanced Skin Cancer	NCT04315701	Recurrent Skin ... Resectable Skin... Stage I Skin Ca... Stage II Skin C... Stage III Skin ...	Cemiplimab Resection	18 Years -	University of Southern California
A PD-1 Checkpoint Inhibitor (Cemiplimab) for High-Risk Localized, Locally Recurrent, or Regionally Advanced Skin Cancer	NCT04315701	Recurrent Skin ... Resectable Skin... Stage I Skin Ca... Stage II Skin C... Stage III Skin ...	Cemiplimab Resection	18 Years -	University of Southern California

Spots Global Cancer Trial Database for stage i skin cancer