Recurrent Skin Squamous Cell Carcinoma Clinical Trial
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
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04428671 -
Cemiplimab Before and After Surgery for the Treatment of High Risk Cutaneous Squamous Cell Cancer
|
Phase 1 | |
| Completed |
NCT01198028 -
Erlotinib in Treating Patients With Recurrent or Metastatic Skin Squamous Cell Carcinoma
|
Phase 2 | |
| Active, not recruiting |
NCT04163952 -
Talimogene Laherparepvec and Panitumumab for the Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Skin
|
Phase 1 |