Testing the Addition of an Immunotherapy Drug, Cemiplimab (REGN2810), Plus Surgery to the Usual Surgery Alone for Treating Advanced Skin Cancer

Phase 3

Not yet recruiting

• Conditions: Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck; Recurrent Skin Squamous Cell Carcinoma; Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck; Resectable Skin Squamous Cell Carcinoma; Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8; Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8

• Registration Number: NCT06568172
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-22
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

Inclusion Criteria:<br><br> - Pathologically (histologically or cytologically) proven diagnosis of invasive<br> cutaneous squamous cell carcinoma (CSCC) or regional lymph node or in-transit<br> metastasis of CSCC<br><br> - For patients with regional metastasis without a primary tumor at screening: a<br> clinical history of CSCC that drains to the involved regional lymph nodes or<br> in-transit metastases in question is required<br><br> - For example, a parotid mass shown to be squamous cell carcinoma (SCC) by<br> cytologic analysis of a fine needle aspirate in a patient with a clinical<br> history of CSCC on the ipsilateral scalp would be eligible<br><br> - For patients with regional metastases without a primary tumor and an ambiguous<br> clinical history: tumor genomic sequencing suggesting a primary tumor of<br> cutaneous origin would be acceptable evidence to establish eligibility<br><br> - NOTE: Tumor genomic sequencing is not required to determine eligibility, but<br> may be part of the routine evaluation of patients with cancers of unknown<br> primary at some institutions. For example, a parotid mass shown to be SCC by<br> cytologic analysis of fine needle aspirate without a primary tumor and an<br> ambiguous clinical history, but with a tumor genomic sequencing assay<br> demonstrating a high tumor mutation burden (= 10 mutations/Mb) and/or a high<br> fraction of ultraviolet (UV) related mutations (> 50% of mutations [cytosine<br> (C)/thymine (T)]C > T or CC > TT) and/or the presence of signature 7<br> mutations would be eligible (Chang 2021)<br><br> - Previously untreated or recurrent CSCC<br><br> - Clinical American Joint Committee on Cancer (AJCC) 8th Edition (head and neck sites)<br> or Union for International Cancer Control (UICC) (non-head and neck sites) stage III<br> or IV<br><br> - Primary tumor site must be in the head and neck cutaneous region, other non-head and<br> neck cutaneous regions, or eyelid cutaneous region<br><br> - No mucosal squamous cell carcinoma (vermillion lip, nasal, oral, sinonasal,<br> conjunctival, anogenital)<br><br> - Tumor must be resectable with curative intent. Note: Tumor with bony skull base<br> invasion and/or skull base foramen involvement (T4b) is not eligible<br><br> - At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors<br> (RECIST) 1.1<br><br> - No definitive clinical or radiologic evidence of distant metastatic disease (M1),<br> visceral and/or distant nodal disease<br><br> - Age = 18<br><br> - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2<br><br> - Not pregnant and not nursing<br><br> - Negative urine or serum pregnancy test (in persons of childbearing potential)<br> within 14 days prior to registration. Childbearing potential is defined as any<br> person who has experienced menarche and who has not undergone surgical<br> sterilization (hysterectomy or bilateral oophorectomy) or who is not<br> postmenopausal<br><br> - Absolute neutrophil count (ANC) = 1,000 cells/mm^3<br><br> - Platelets = 75,000 cells/mm^3<br><br> - Hemoglobin = 8.0 g/dl (Note: The use of transfusion or other intervention to achieve<br> hemoglobin [Hgb] = 8.0 g/dl is acceptable)<br><br> - Serum creatinine = 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCL)<br> > 30mL/min by the Cockcroft-Gault formula<br><br> - Total bilirubin = 1.5 x institutional upper limit of normal (ULN) (not applicable to<br> patients with known Gilbert's syndrome)<br><br> - Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])<br> and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =<br> 3 x institutional ULN<br><br> - No prior systemic therapy for the study cancer<br><br> - No prior radiotherapy to the region of the study cancer that would result in<br> cumulative doses of radiation to organs at risk for radiation injury that exceed<br> protocol limitations<br><br> - No history of myocardial infarction within the last 6 months<br><br> - New York Heart Association functional classification IIb or better (New York Heart<br> Association [NYHA] functional classification III/IV are not eligible) (Note:<br> Patients with known history or current symptoms of cardiac disease, or history of<br> treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac<br> function using the New York Heart Association functional classification)<br><br> - No active infection requiring systemic antibiotics, antiviral, or antifungal<br> treatments<br><br> - No history of allogeneic stem cell transplantation, or autologous stem cell<br> transplantation<br><br> - No history of a solid organ transplant (other than corneal transplant)<br><br> - No active, known, or suspected autoimmune disease<br><br> - Active or known disease is defined as:<br><br> - Requiring higher than physiologic steroid levels (> 10mg prednisone/day or<br> equivalent) or<br><br> - Requiring disease-modifying agents or<br><br> - Ongoing or recent (within 5 years prior to registration) evidence of<br> significant autoimmune disease that required treatment with systemic<br> immunosuppressive treatments, which may suggest risk for immune-related<br> adverse events (irAEs)<br><br> - NOTES:<br><br> - Patients who require a brief course of steroids (eg, prophylaxis for<br> imaging assessments due to hypersensitivity to contrast agents) are not<br> excluded<br><br> - Patients with type I diabetes mellitus, and endocrinopathies (including<br> hypothyroidism due to autoimmune thyroiditis) only requiring hormone<br> replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia)<br> not requiring systemic treatment, or conditions not expected to recur in<br> the absence of an external trigger are permitted to enroll<br><br> - Physiologic replacement doses = 10 mg prednisone/day or equivalent<br> allowed, as long as they are not being administered for immunosuppressive<br> intent. Inhaled or topical steroids are permitted<br><br> - No history of interstitial lung disease (eg, idiopathic pulmonary fibrosis,<br> organizing pneumonia)<br><br> - No active, noninfectious pneumonitis requiring immune-suppressive therapy<br><br> - No active tuberculosis<br><br> - Patients with HIV infection on effective anti-retroviral therapy with undetectable<br> viral load within 6 months prior to registration are eligible<br><br> - Patients with chronic lymphocytic leukemia (CLL) with no history of anti-CLL therapy<br> within 6 months prior to registration are eligible<br><br> - No live vaccines within 28 days prior to registration<br><br> - No history of allergic reaction to the study agent, compounds of similar chemical or<br> biologic composition to the study agent (or any of its excipients)

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event-free survival (EFS)

Secondary Outcome Measures

Name	Time	Method
Disease-free survival (DFS);Overall survival (OS);Incidence of adverse events;Pathologic complete response