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Closed (no longer recruiting)Last updated: 2 February 2024

This phase II trial is trying to determine how effective a targeted therapy is in the neoadjuvant (pre-) treatment of cutaneous squamous cell carcinomaA Phase 2 Study of Neoadjuvant Cemiplimab for Stage II to IV (M0) Cutaneous Squamous Cell Carcinoma (CSCC)

Clinical summary

Summary

Eligible patients will receive intravenous cemiplimab every three weeks.

Conditions

This trial is treating patients with cutaneous squamous cell carcinoma.

Cancer

Skin Cancers Skin

Age

People18+

Phase

II

More information

Trial Identifiers

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Trial sponsor

Regeneron Pharmaceuticals

Scientific Title

A Phase 2 Study of Neoadjuvant Cemiplimab for Stage II to IV (M0) Cutaneous Squamous Cell Carcinoma (CSCC)

Eligibility

Inclusion

  • Stage II to IV (M0) CSCC, for which surgery would be recommended in routine clinical practice. For stage II patients, lesion must be ≥3 cm at the longest diameter.
  • At least 1 lesion that is measurable by RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ, bone marrow function, and hepatic function as defined in the protocol

Exclusion

  • Solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy (including chronic lymphocytic leukemia [CLL]) at any time
  • Distant metastatic disease (M1), visceral and/or distant nodal
  • Prior radiation therapy for CSCC
  • Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of the first dose of study drug.
  • Patients with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date.
  • History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management.
  • Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus (HBV or HCV) infection; or diagnosis of immunodeficiency
  • Active tuberculosis

NOTE: Other protocol-defined Inclusion/Exclusion Criteria apply

Inclusion

  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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