Neoplasms

All Conditions

Symptoms and General Pathology

Carcinoma

Carcinoma, Squamous Cell

Recurrence

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Cemiplimab

Antineoplastic Agents, Immunological

Immunocompromised patients will be given Cemiplimab-rwlc every 3 weeks

Cemiplimab-rwlc will be administered as a flat dose of 350 mg IV over approximately 30 minutes every 21 days (+/- 3 days)

Cemiplimab-Rwlc

Christine H Chung, MD

The purpose of this research study is to determine how people with weakened immune systems and unresectable (cannot be removed by surgery) locally recurrent and/or metastatic cutaneous squamous cell carcinoma (CSCC) respond to study treatment with Cemiplimab. Cemiplimab is approved for sale in United States by the U.S. Food and Drug Administration (FDA).

Cemiplimab-rwlc for Unresectable Locally Recurrent and/or Metastatic CSCC

A Single Arm Phase II Study of Cemiplimab-rwlc in Immunocompromised Patients With Unresectable Locally Recurrent and/or Metastatic Cutaneous Squamous Cell Carcinoma (CSCC)

Overall Response Rate (ORR) as indicated by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 analysis of radiologic scans. In some patients, response assessments include photos and radiologic scans and will be evaluated by composite efficacy criteria.

Clinical lesions will only be considered measurable when they are superficial (eg, skin nodules and palpable lymph nodes) and ≥10 mm (≥1 cm) diameter as assessed using calipers (e.g., skin nodules). Patients who are deemed as not evaluable according to RECIST 1.1 or inevaluable by the composite efficacy criteria will be considered as not reaching ORR.

Progression Free Survival (PFS), defined as time from on study date to disease progression

Overall Survival (OS), defined as time from on study date to death from any cause

Regeneron Pharmaceuticals

H. Lee Moffitt Cancer Center and Research Institute

Immunocompromised patients will be given Cemiplimab-rwlc every 3 weeks

Cemiplimab-Rwlc: Cemiplimab-rwlc will be administered as a flat dose of 350 mg IV over approximately 30 minutes every 21 days (+/- 3 days)

Spots Global Cancer Trial Database for Cemiplimab-rwlc for Unresectable Locally Recurrent and/or Metastatic CSCC

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

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