Clinical Trial 23590

• Overview

  Study Title:

  Randomized Phase III Trial of Neoadjuvant Immunotherapy with Response-Adapted Treatment versus Standard-Of-Care Treatment for Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma

  Objective:

  Primary Objective *To determine if neoadjuvant immunotherapy combined with response-adapted oncologic surgery improves site-reported event-free survival (EFS) compared to standard-of-care surgery in resectable stage III/IV CSCC. Secondary Objectives * To compare disease-free survival (DFS) between arms. * To compare overall survival (OS) between arms. * To compare adverse events (CTCAE v5.0) between

• Treatments

  Therapies:

  Immunotherapy; Radiotherapy; Surgery

  Medications:

  Cemiplimab (); REGN2810 (Cemiplimab); Radiotherapy ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Previously untreated or recurrent CSCC
  • Clinical American Joint Committee on Cancer (AJCC) 8th Edition (head and neck sites) or Union for International Cancer Control (UICC) (non-head and neck sites) stage III or IV
  • Primary tumor site must be in the head and neck cutaneous region, other non-head and neck cutaneous regions, or eyelid cutaneous region
  • No mucosal squamous cell carcinoma (vermillion lip, nasal, oral, sinonasal, conjunctival, anogenital)
  • Tumor must be resectable with curative intent. Note: Tumor with bony skull base invasion and/or skull base foramen involvement (T4b) is not eligible. (Patients with T4b eyelid tumors using UICC Staging, and not involving the brain, are eligible).
  • At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • No definitive clinical or radiologic evidence of distant metastatic disease (M1), visceral and/or distant nodal disease
  • Age ≥ 18
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Not pregnant and not nursing
  • Absolute neutrophil count (ANC) ≥ 1,000 cells/mm^3
  • Platelets ≥ 75,000 cells/mm^3
  • Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] ≥ 8.0 g/dl is acceptable)
  • Creatinine clearance (CrCL) > 30mL/min by the Cockcroft-Gault formula
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (NOTE: For patients with Gilbert's syndrome, total bilirubin ≤ 3 x ULN. Gilbert's syndrome must be documented appropriately as past medical history.)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 3 x institutional ULN
  • No prior systemic therapy for the study cancer (including patients currently receiving immunotherapy for a separate malignancy).
  • No prior radiotherapy to the region of the study cancer that would result in cumulative doses of radiation to organs at risk for radiation injury that exceed protocol limitations
  • No history of myocardial infarction/unstable angina within the last 6 months
  • New York Heart Association functional classification IIb or better (New York Heart Association [NYHA] functional classification III/IV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification)
  • No active infection requiring systemic antibiotics, antiviral, or antifungal treatments
  • No history of allogeneic stem cell transplantation, or autologous stem cell transplantation
  • No history of a solid organ transplant (other than corneal transplant)
  • No active, known, or suspected autoimmune disease
  • No history of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia)
  • No active, noninfectious pneumonitis requiring immune-suppressive therapy
  • No active tuberculosis
  • No live vaccines within 28 days prior to registration
  • No history of allergic reaction to the study agent, compounds of similar chemical or biologic composition to the study agent (or any of its excipients)
  • Additional Criteria may apply

• Exclusion Criteria

  Key Exclusion Criteria:
  • Not meeting all of the inclusion criteria

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