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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06418724
Registration number
NCT06418724
Ethics application status
Date submitted
12/04/2024
Date registered
17/05/2024
Date last updated
3/06/2025
Titles & IDs
Public title
Neoadjuvant PD-1 Inhibitor and EGFR Inhibitor in Locally Advanced Cutaneous Squamous Cell Carcinoma
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Scientific title
Neoadjuvant PD-1 Inhibitor and EGFR Inhibitor in Locally Advanced Cutaneous Squamous Cell Carcinoma
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Secondary ID [1]
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02.23
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Universal Trial Number (UTN)
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Trial acronym
NEOPECS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Locally Advanced Cutaneous Squamous Cell Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Cetuximab
Treatment: Drugs - Cemiplimab
Experimental: Cetuximab and Cemiplimab - All patients will be administered the same treatment combination.
Cemiplimab will be administered 350mg intravenously every 21 days. A maximum of 4 cycles will be given.
Cetuximab will be administered 400mg/m2 loading dose on day 1 and 250mg/m2 on day 8 and day 15 for a 21 day cycle for first cycle. Cetuximab will be administered 250mg/m2 on day 1, 8 and 15 for a 21 day cycle for subsequent cycles for 4 cycles.
Treatment: Drugs: Cetuximab
Cetuximab is a monoclonal antibody against epidermal growth factor receptor (EGFR). EGFR is over-expressed in many human cancers, including colorectal cancers.
Treatment: Drugs: Cemiplimab
Cemiplimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with its ligands programmed death-ligand 1 (PD-L1) and programmed death-ligand 2 (PD-L2). Engagement of PD-1 with its ligands PD-L1 and PD-L2, which are expressed by antigen presenting cells and may be expressed by tumour cells and/or other cells in the tumour microenvironment, results in inhibition of T cell function such as proliferation, cytokine secretion, and cytotoxic activity. Cemiplimab potentiates T cell responses, including antitumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Preliminary activity
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Assessment method [1]
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The primary preliminary activity endpoint will be the achievement of clinical downstaging from borderline resectable status to either resectable status or surgery avoidance due to complete metabolic response with no residual pathological disease as deemed by Multi-Disciplinary Team (MDT) consensus evaluation following up to 4 cycles of neoadjuvant therapy.
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Timepoint [1]
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3 months
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Secondary outcome [1]
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Treatment safety and feasibility as assessed by NCI CTCAE v5
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Assessment method [1]
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Safety and feasibility by assessment of Common Terminology Criteria for Adverse Events (CTCAE) V5.0 with the incidence of = Grade 3 adverse events, \< Grade 3 adverse events and SAEs and AEs leading to study treatment discontinuation.
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Timepoint [1]
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12 months
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Secondary outcome [2]
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Treatment safety and feasibility as assessed by rate of R0 resection
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Assessment method [2]
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Safety and feasibility by assessment of change in rate of R0 resection. R0 resection is defined no residual tumour in surgically removed specimen of curative intent per local and central pathology review.
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Timepoint [2]
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12 months
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Secondary outcome [3]
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Pathological response rate
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Assessment method [3]
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Preliminary efficacy by assessment of pathological response rate, including complete (0% residual tumour cells) and major (0-10% residual tumour cells) pathological responses, by blinded central pathology review. Complete pathological response (pCR) defined as absence of viable tumor cells in surgical specimen. Major pathological response (MPR) defined as 0-10% viable tumor cells in surgical specimen.
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Timepoint [3]
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12 months
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Secondary outcome [4]
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Overall response rate (ORR)
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Assessment method [4]
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Preliminary efficacy by assessment of overall response rate (ORR) as per Modifed Response Evaluation Criteria in Solid Tumors for immune based therapeutics (iRECIST) criteria or investigator caliper assessment where disease is un-measurable by CT or MRI modalities
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Timepoint [4]
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12 months
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Secondary outcome [5]
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Progression free survival (PFS)
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Assessment method [5]
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Preliminary efficacy by assessment of 12-month and median PFS using the Kaplan-Meier method. PFS is defined as the interval from date of registration to the date of first evidence of disease progression or death, whichever occurs first.
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Timepoint [5]
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12 months
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Secondary outcome [6]
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Event-free survival (EFS)
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Assessment method [6]
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Preliminary efficacy by assessment of 12-month and median EFS using the Kaplan-Meier method. EFS is defined as the interval from date of registration to progressive disease or adverse events precluding surgery, inability to undergo complete (R0) resection, disease recurrence or death from any cause.
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Timepoint [6]
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12 months
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Secondary outcome [7]
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Overall survival (OS)
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Assessment method [7]
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Preliminary efficacy by assessment of 12-month and median OS using the Kaplan-Meier method. OS is defined as the interval from date of registration to date of death from any cause, or the date of last known follow-up alive.
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Timepoint [7]
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12 months
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Secondary outcome [8]
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Change in predicted difficulty of surgical resection and repair
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Assessment method [8]
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Change in predicted difficulty of surgical resection and repair pre- and post-neoadjuvant therapy as measured with paired surgeon-rated scaling "scale for predicted operability of cutaneous SCC". Scale scores range from Inoperable disease (A) to Complete response (F)
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Timepoint [8]
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3 months
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Eligibility
Key inclusion criteria
1. Male or female > 18 years of age and able to comply with treatment, assessment and follow up
2. Documentation of a locally advanced cutaneous squamous cell carcinoma diagnosis as evidenced by histopathology with available archival tissue. Locally Advanced cutaneous Squamous Cell Carcinoma (LASCC) defined as borderline resectable for surgery due to multiple recurrences, prior radiotherapy, large extension, bone erosion and/or deep infiltration beyond the subcutaneous tissue into muscle/nerve or, where curative resection may lead to unacceptable complications, morbidity or deformity, and ineligible for curative radiotherapy
3. Measurable disease in accordance with iRECIST criteria OR clinically measurable disease >1cm by caliper measurement. Patients with synchronous primary cutaneous squamous cell carcinoma (cSCC) tumours will be eligible.
4. Adequate bone marrow function with haemoglobin >100g/L, absolute neutrophil count > 1.5 x 109/L, platelets > 100 x 109/L). Blood transfusion is allowable.
5. Adequate hepatic function with total bilirubin levels <1.5 upper limit normal range and Alanine aminotransferase (ALT) and AST levels <2.5 level normal range.
6. Adequate renal function with eGFR estimated with Cockcroft Gault formula >50mL/min. Serum potassium levels 3.5 - 5.5 mmoL/L, Serum magnesium levels 0.7 - 1.05 mmol/L, Serum corrected calcium levels 2.15 - 2.55 mmol/L
7. Adequate performance status of Eastern Cooperative Oncology Group (ECOG) 0-1 as assessed by investigator
8. Life expectancy of >6 months
9. Able to provide written informed consent obtained from patient and ability for patient to comply with the requirements of the trial.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Distant metastatic disease (M1) including visceral or distant nodal metastases
2. Prior receipt of checkpoint inhibitor therapy or anti-EGFR therapy for LASCC or any other malignancy
3. Uncontrolled medical/psychiatric co-morbidity as per investigator that may jeopardize the ability of the patient to undergo trial procedures with reasonable safety
4. Uncontrolled autoimmune disease requiring active immune-suppression within 1 year of enrolment
5. Corticosteroid use of >10mg daily of oral prednisone within 2 weeks of Cycle 1 Day 1 (C1D1)
6. Known history of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases.
7. Uncontrolled infection with human immunodeficiency virus, hepatitis B, or hepatitis C infection; or has a diagnosis of immunodeficiency
8. Transplant recipient
9. Hepatitis C virus (HCV) and hepatitis B virus (HBV) testing will be performed at screening
10. Controlled HIV infection (undetectable viral load (HIV RNA PCR) and Cluster of differentiation 4 (CD4) counts above 350 either spontaneously or on a stable antiviral regimen) is permitted. Monitoring will be performed per local standards.
11. Controlled hepatitis B antibody positive infection (HBsAg+) is permitted providing a serum hepatitis B virus DNA PCR that is below the limit of detection and patient is receiving anti-viral therapy for hepatitis B. Periodic monitoring of HBV DNA is required. Anti-viral therapy for at least 6 months post the last dose of investigational study drug is required.
12. Controlled hepatitis C virus antibody positive (HCV Ab+) is permitted (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy).
13. History of another malignancy within 5 years prior to trial registration. A past history of adequately treated carcinoma-in-situ, basal cell carcinoma of skin, or superficial transitional cell carcinoma of the bladder is permitted. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 3 years after definitive primary treatment and low expected risk of recurrence.
14. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with trial protocol and follow-up schedule, including alcohol and drug abuse.
15. Pregnancy, lactation or inadequate contraception. Women must be post-menopausal, infertile or willing to use reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilized or willing to use double barrier contraception.
16. Sexually active men and women of childbearing potential who are unwilling to practice highly effective contraception prior to the start of the first treatment, during the study, and for at least 6 months after the last dose of investigational drug.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
11/12/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2028
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Actual
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Sample size
Target
27
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Primary sponsor type
Other
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Name
Melanoma and Skin Cancer Trials Limited
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The NEOPECS trial is a phase II prospective, single-arm, non-randomised interventional trial for patients with borderline resectable locally advanced cutaneous squamous cell carcinoma with a 6-participant safety lead in to ensure safety of the combination in the neoadjuvant setting across 3 sites in Australia.
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Trial website
https://clinicaltrials.gov/study/NCT06418724
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Jia (Jenny) Liu, MD, PhD, FRACP
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Address
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Kinghorn Cancer Centre/St Vincent's Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Melanoma and Skin Cancer Trials Ltd Project Officer
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Address
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Country
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Phone
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+61 3 9903 9022
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06418724
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