RECRUITING

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

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Conditions

Recurrent Cutaneous Squamous Cell Carcinoma of the Head and NeckRecurrent Skin Squamous Cell CarcinomaResectable Cutaneous Squamous Cell Carcinoma of the Head and NeckResectable Skin Squamous Cell CarcinomaStage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase III trial compares the effect of adding cemiplimab to standard therapy (surgery with or without radiation) versus standard therapy alone in treating patients with stage III/IV squamous cell skin cancer that is able to be removed by surgery (resectable) and that may have come back after a period of improvement (recurrent). The usual treatment for patients with resectable squamous cell skin cancer is the removal of the cancerous tissue (surgery) with or without radiation, which uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. 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. Cemiplimab has been approved for the treatment of skin cancer that has spread or that cannot be removed by surgery, but it has not been approved for the treatment of skin cancer than can be removed by surgery. Adding cemiplimab to the usual treatment of surgery with or without radiation may be more effective in treating patients with stage III/IV resectable squamous cell skin cancer than the usual treatment alone.

Official Title

Randomized Phase III Trial of Perioperative Immunotherapy With Response-Adapted Treatment Versus Standard-of-Care Treatment for Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma

Quick Facts

Study Start:2025-09-16
Study Completion:2031-08-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06568172

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pathologically (histologically or cytologically) proven diagnosis of invasive cutaneous squamous cell carcinoma (CSCC) or regional lymph node or in-transit metastasis of CSCC
  2. * For patients with regional metastasis without a primary tumor at screening: a clinical history of CSCC that drains to the involved regional lymph nodes or in-transit metastases in question is required
  3. * For example, a parotid mass shown to be squamous cell carcinoma (SCC) by cytologic analysis of a fine needle aspirate in a patient with a clinical history of CSCC on the ipsilateral scalp would be eligible
  4. * For patients with regional metastases without a primary tumor and an ambiguous clinical history: tumor genomic sequencing suggesting a primary tumor of cutaneous origin would be acceptable evidence to establish eligibility
  5. * NOTE: Tumor genomic sequencing is not required to determine eligibility, but may be part of the routine evaluation of patients with cancers of unknown primary at some institutions. For example, a parotid mass shown to be SCC by cytologic analysis of fine needle aspirate without a primary tumor and an ambiguous clinical history, but with a tumor genomic sequencing assay demonstrating a high tumor mutation burden (≥ 10 mutations/Mb) and/or a high fraction of ultraviolet (UV) related mutations (\> 50% of mutations \[cytosine (C)/thymine (T)\]C \> T or CC \> TT) and/or the presence of "signature 7" mutations would be eligible (Chang 2021)
  6. * Previously untreated or recurrent CSCC
  7. * 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
  8. * Primary tumor site must be in the head and neck cutaneous region, other non-head and neck cutaneous regions, or eyelid cutaneous region
  9. * No mucosal squamous cell carcinoma (vermillion lip, nasal, oral, sinonasal, conjunctival, anogenital)
  10. * Tumor must be resectable with curative intent. Note: Tumor with bony skull base invasion and/or skull base foramen involvement (T4b) is not eligible
  11. * At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  12. * No definitive clinical or radiologic evidence of distant metastatic disease (M1), visceral and/or distant nodal disease
  13. * Age ≥ 18
  14. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  15. * Not pregnant and not nursing
  16. * Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal
  17. * Absolute neutrophil count (ANC) ≥ 1,000 cells/mm\^3
  18. * Platelets ≥ 75,000 cells/mm\^3
  19. * Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] ≥ 8.0 g/dl is acceptable)
  20. * Creatinine clearance (CrCL) \> 30mL/min by the Cockcroft-Gault formula
  21. * 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.)
  22. * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 3 x institutional ULN
  23. * No prior systemic therapy for the study cancer
  24. * 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
  25. * No history of myocardial infarction within the last 6 months
  26. * 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)
  27. * No active infection requiring systemic antibiotics, antiviral, or antifungal treatments
  28. * No history of allogeneic stem cell transplantation, or autologous stem cell transplantation
  29. * No history of a solid organ transplant (other than corneal transplant)
  30. * No active, known, or suspected autoimmune disease
  31. * Active or known disease is defined as:
  32. * Requiring higher than physiologic steroid levels (\> 10mg prednisone/day or equivalent) or
  33. * Requiring disease-modifying agents or
  34. * Ongoing or recent (within 5 years prior to registration) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs)
  35. * NOTES:
  36. * Patients meeting the following criteria are not considered immunosuppressed and are eligible to enroll:
  37. * Patients who require a brief course of steroids (eg, prophylaxis for imaging assessments due to hypersensitivity to contrast agents) are not excluded
  38. * Patients with type I diabetes mellitus, and endocrinopathies (including hypothyroidism due to autoimmune thyroiditis) only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
  39. * Physiologic replacement doses ≤ 10 mg prednisone/day or equivalent allowed, as long as they are not being administered for immunosuppressive intent. Inhaled or topical steroids are permitted
  40. * Patients with the following immunosuppressed conditions are eligible to enroll:
  41. * Patients with HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible
  42. * Patients with chronic lymphocytic leukemia (CLL) with no history of anti-CLL therapy within 6 months prior to registration are eligible
  43. * No history of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia)
  44. * No active, noninfectious pneumonitis requiring immune-suppressive therapy
  45. * No active tuberculosis
  46. * No live vaccines within 28 days prior to registration
  47. * 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)
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Neil D Gross
PRINCIPAL_INVESTIGATOR
NRG Oncology

Study Locations (Sites)

NRG Oncology
Philadelphia, Pennsylvania, 19103
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

  • Neil D Gross, PRINCIPAL_INVESTIGATOR, NRG Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-16
Study Completion Date2031-08-14

Study Record Updates

Study Start Date2025-09-16
Study Completion Date2031-08-14

Terms related to this study

Additional Relevant MeSH Terms

  • 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