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

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Trial Identification

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

Official Title: 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

Study ID: NCT04315701

Interventions

Cemiplimab
Resection

Study Description

Brief Summary: 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Los Angeles County-USC Medical Center, Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

Hoag Memorial Hospital, Newport Beach, California, United States

Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States

Contact Details

Name: Gino K In, MD

Affiliation: University of Southern California

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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