NCT04315701

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Skin Squamous Cell Carcinoma
• Resectable Skin Squamous Cell Carcinoma
• Stage I Skin Cancer
• Stage II Skin Cancer
• Stage III Skin Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Cemiplimab	Given IV
PROCEDURE	Resection	Undergo surgical resection

Timeline

• Start date: 2020-06-17
• Primary completion: 2025-11-12
• Completion: 2027-06-17
• First posted: 2020-03-19
• Last updated: 2025-11-20

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study