Neoplasms

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Carcinoma

Carcinoma, Squamous Cell

Recurrence

Skin Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Neoplasms, Squamous Cell

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

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.

National Cancer Institute (NCI)

University of Southern California

Atezolizumab

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Immune Checkpoint Inhibitors

Immunologic Factors

Patients undergo SBRT on days 1, 3, 5, 7, and 9 of cycle 1. Beginning 1-2 days after SBRT, patients also receive atezolizumab IV on day 1. Treatment repeats every 3 weeks for 3 cycles in the absence of disease progression or unacceptable toxicity.

Stereotactic Body Radiation Therapy

Arya Amini

This phase I trial tests the safety and side effects radiotherapy in combination with atezolizumab in treating patients with cutaneous squamous cell cancer that has spread to nearby tissue or lymph nodes (locally advanced) and can be removed from surgery (resectable) or cannot be remove by surgery (unresectable). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving radiotherapy in combination with atezolizumab may help improve outcomes for remission (cancer that is under control) than taking either treatment separately.

PRIMARY OBJECTIVE:

I. To determine the safety profile of combination of atezolizumab + radiation therapy (RT) in borderline resectable or unresectable cutaneous squamous cell carcinoma (cSCC).

SECONDARY OBJECTIVES:

I. Determine pathologic response after neoadjuvant atezolizumab + RT. II. Determine clinical response (via imaging and clinical exam) postoperatively (if surgically resectable) or at post-treatment biopsy (if not surgically resectable), and 3 months following the completion of surgery or RT (if not surgically resectable).

III. Define the toxicity profile associated with the treatment protocol. IV. Assess short-term quality-of-life associated with the treatment protocol.

EXPLORATORY OBJECTIVES:

I. To compare immune checkpoint molecule (e.g. PD1, PD-L1, TIM3, TIGIT, etc.) expression intensity within tumor cells and immune cells in the tumor microenvironment, as well as immune cell subset infiltration patterns including T cells before and after atezolizumab + stereotactic body radiation therapy (SBRT) by multiplex immunohistochemistry (or immunofluorescence).

II. To evaluate the impact of tumor molecular features on immune response and treatment outcome using next generation targeted deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) sequencing of pre-treatment tumor tissue.

III. To compare changes in circulating immune cell subsets in peripheral blood by RNA-based T-cell receptor (TCR)-sequencing and immunophenotyping by flow cytometry (or immunophenotyping by single-cell RNA sequencing), and correlate changes with response, clinical outcomes, and toxicity.

IV. To evaluate circulating tumor DNA (ctDNA) levels before start of treatment and immediately prior to surgery/repeat biopsy.

OUTLINE:

Patients undergo SBRT on days 1, 3, 5, 7, and 9 of cycle 1. Beginning 1-2 days after SBRT, patients also receive atezolizumab intravenously (IV) on day 1. Treatment repeats every 3 weeks for 3 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study, patients are followed up every 12 weeks for 24 months.

Radiotherapy in Combination With Atezolizumab in Locally Advanced Borderline Resectable or Unresectable Cutaneous SCC

Phase I Trial of Radiotherapy in Combination With Atezolizumab in Borderline Resectable and Unresectable Cutaneous Squamous Cell Carcinoma(cSCC)

Toxicity will be assessed by Common Terminology Criteria for Adverse Events version 5 criteria.

Will be calculated as the ratio of the number of patients who demonstrated a complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) divided by the number of patients evaluable for response.

Will be examined using the Kaplan-Meier method. Median OS and corresponding two-sided 95% confidence intervals will be computed.

Will be examined using the Kaplan-Meier method. Median PFS and corresponding two-sided 95% confidence intervals will be computed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Radiotherapy in Combination With Atezolizumab in Locally Advanced Borderline Resectable or Unresectable Cutaneous SCC	NCT05085496	Locally Advance... Resectable Skin... Unresectable Sk...	Atezolizumab Stereotactic Bo...	18 Years -	City of Hope Medical Center
Radiotherapy in Combination With Atezolizumab in Locally Advanced Borderline Resectable or Unresectable Cutaneous SCC	NCT05085496	Locally Advance... Resectable Skin... Unresectable Sk...	Atezolizumab Stereotactic Bo...	18 Years -	City of Hope Medical Center
Radiotherapy in Combination With Atezolizumab in Locally Advanced Borderline Resectable or Unresectable Cutaneous SCC	NCT05085496	Locally Advance... Resectable Skin... Unresectable Sk...	Atezolizumab Stereotactic Bo...	18 Years -	City of Hope Medical Center

Spots Global Cancer Trial Database for resectable skin squamous cell carcinoma