Immunotherapy in Perineural Spread of Cutaneous Squamous Cell Carcinoma - IPERCS
A single arm, phase II trial of Cemiplimab in Head and Neck Cutaneous Squamous Cell Carcinoma with Large Nerve Perineural Spread
Metro South Hospital and Health Services
22 participants
Mar 2, 2026
Interventional
Conditions
Summary
This study is investigating whether an immunotherapy drug (Cemiplimab) is effective as a treatment for cutaneous squamous cell carcinoma (a skin cancer of the head and neck), particularly for patients who have had their cancer spread to large nerves within the head and neck area. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with stage 3-4 cutaneous squamous cell carcinoma (cSCC) and you also have been diagnosed with a spread of this cancer into large peripheral nerves (also known as large-nerve perineural spread). Study details There is only one treatment available as part of this study, all participants who choose to enrol will be offered the same immunotherapy treatment. Cemiplimab will be given to participants via an infusion into a vein, once every 3 weeks for up to 8 treatment cycles (approximately 6 months). Participants will need to attend their local hospital to receive this treatment and to undergo additional CT and MRI scans to review their nerves that may have been impacted by the cancer. Participants will be asked to undergo CT and MR imaging at the time that they enrol in the study, then at 6 weeks, 12 weeks and then at 12-weekly increments for a maximum of 5 years. It is hoped that this study will help us understand whether cemiplimab can shrink the tumour, in which patients this may be more likely to occur, and any side effects that may be experienced during this study. This may help to treat other patients with cSCC of the skin in future and reduce the impact of this type of cancer on the nearby nerves in the head and neck.
Eligibility
Inclusion Criteria27
- Histologically confirmed history of cutaneous cell carcinoma (cSCC)
- Large Nerve-Perineural Spread (LN-PNS) defined as clinical and /or radiologic involvement of named nerves (UICC 2015 )
- Stage III-IV cSCC as defined by AJCC8th edition
- Measurable LN-PNS on baseline MRI
- Absence of distant metastatic disease on baseline imaging
- ECOG performance status 0-1
- Participants must have adequate organ function as defined below:
- Laboratory Value
- Haematological
- Absolute neutrophil count (ANC): equal to 1500 cells/µL without granulocyte colony-stimulating factor (G- CSF) support within 2 weeks prior to the first dose of study treatment
- Platelets: equal to 100 000/µL
- Haemoglobin: equal to 9 g/dL or equal to 5.6 mmol/L. Participants are eligible if levels are reached after blood transfusion.
- Renal: a Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) equal to1.5 × ULN OR equal to 45 mL/min for participants with creatinine levels
- greater than 1.5 × institutional ULN
- Hepatic: bTotal bilirubin equal to 1.5 × ULN OR direct bilirubin equal to ULN for participants with total bilirubin levels greater than 1.5 × ULN
- AST: (SGOT) and ALT
- (SGPT) equal to 2.5 × ULN
- Coagulation: international normalized ratio (INR)
- OR PT and aPTT equal to 1.5 × ULN unless participant is receiving anticoagulant therapy as long as prothrombin time (PT) or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants
- a. Creatinine clearance should be calculated per institutional standard.
- b. For participants with Gilbert's disease, total bilirubin may be greater than 1.5 × ULN; however, direct bilirubin must be normal.
- c. Partial thromboplastin time (PTT) may be performed if the local laboratory is unable to perform aPTT.
- Participants must have a life expectancy of greater than 6 months
- Be at least 18 years of age
- Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hrs prior to receiving the first dose of medication
- Female participants of childbearing potential must agree to use a highly effective method of contraception during the treatment period and for at least 120 days after the last dose.
- The participant or legal representative must be willing and able to sign to provide written informed consent.
Exclusion Criteria18
- Participant with distant metastatic cSCC
- Participants with any prior allogeneic solid organ or hematopoietic stem cell transplantations are excluded.
- Participant has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
- Participant has received prior systemic anti-cancer therapy including investigational agents for cSCC.
- Participant has received prior radiotherapy to the target lesion.
- Participant has a contraindication to MRI
- Participant is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of trial treatment.
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments (eg, with use of disease-modifying agents, anticoagulants, corticosteroids or immunosuppressive drugs)., which may suggest risk for immune-related adverse events (irAEs) or has a diagnosis of immunodeficiency disorders (such as organ transplantation or hematologic malignancies associated with immune suppression).
- Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial drug.
- Has uncontrolled infection with human immunodeficiency virus, hepatitis B, or hepatitis C infection; or has a diagnosis of immunodeficiency
- a. Patients with known HIV infection who have controlled infection (undetectable viral load (HIV RNA PCR) and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted.
- b. Patients with hepatitis B (HBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection and receiving anti-viral therapy for hepatitis B) are permitted. Patients must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.
- c. Patients who are hepatitis C virus antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) may be enrolled into the study.
- Participant has a diagnosis and/or has been treated for additional malignancy within the past 3 years prior to allocation.
- Participant has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Participant has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
- Participant has a known psychiatric or substance abuse disorder that would interfere with the participant’s ability to cooperate with the requirements of the trial.
- Participant is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
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Interventions
Single arm, nonrandomised Cemiplimab intravenous 350mg every three weeks for 8 cycles. Patients will attend the day oncology unit at their treating institution for administration of Cemiplimab 350mg every 3 weeks for a period of 24 weeks. Patient will be monitored as per industry standards and guidelines. Patients will be assessed for response via medical imaging. The mode of medical imaging to be used in this study is Computer Tomography (CT), Positron Emission Tomography (PET/CT and Magnetic Resonance Imaging (MRI) with contrast. These modes of imaging require a contrast dye which is administered intravenously. The amount of contrast needed can vary dependant on patient weight, but approximately 30-120ml of contrast is needed. A CT scan can take up to 30 mins to perform An MRI can take up to 30 mins to perform All imaging is performed by a qualified radiologist at the patient's treating institution. Imaging scans are required at screening, 6 weeks and 12 weeks during the treatment phase. Imaging is required every 3 months during for follow up phase until disease progression, withdrawal of consent of death.
Locations(2)
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ACTRN12625000197437