Brief Summary
Cutaneous Squamous Cell Carcinomacancer arising from tissues that line organs (cSCC) is typically associated with a high tumoura tissue mass that forms from groups of unhealthy cells mutation burden, with the majority caused by Ultraviolet (UV) exposure (Pickering et al., 2014).
The use of this trial using neoadjuvant Pembrolizumab in patients with cSCC who will otherwise undergo highly morbid radical surgical resectionsurgical removal of tissue or part/all of an organ has multiple potential advantages, including:
- Reduction in surgical and radiotherapy morbidity by reducing tumour burden and allowing the appropriate selection of patients to undergo post-operative radiotherapy;
- Provision of immediate information about pathological response and
- Access to tissuea group of cells that work together to perform a function to provide insight into resistance mechanisms and identification of biomarkers of response.
The Investigators hypothesized that the use of neoadjuvant Pembrolizumab could reduce tumour burden allowing appropriate selection of patients undergoing radical surgical resection and adjuvant radiotherapy.
Intervention / Treatment
- Drug: Pembrolizumab
Inclusion Criteria:
- Histologically confirmed diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of invasive cSCC that is locally advancedat a late stage, far along (Stage II-IV on AJCC 8th edition) assessed preoperatively as sufficiently high riskthe possibility that something bad will happen that they will warrant post-operatively RT (as recommended by MDT) who is a candidate for a complete resection.
Note: Participants with tumors arising on cutaneous non-glabrous (hair-bearing) lip with extension onto vermillion (dry red lip) may be eligible after communicationHow we talk to each other; how we share our knowledge, what we know with each other. and approval from the principal investigator. Participants for whom the primary site is the nose may be eligible after communication and approval from the MDT if the primary site is skin, not nasal mucosa with outward extension to skin. Participants who have squamous cell parotid metastases and have been treated previously for cSCC are permitted. cSCC that has recurred in the same location after 2 or more surgical procedures are not eligible.
- Participants must have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Participants must have an Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0 to 1 within 10 days prior to the start of treatment.
- Participants must have adequate organ function
- Participants must have a tissue sample adequate for translational research. This tissue sample may be obtained from either a newly obtained core or excisional biopsyremoval of a section of tissue to analyse for cancer cells.
- Participants must have a life expectancy of greater than 6 months.
- Be at least 18 years of age on the day of signing the informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment.. 8. Female participants: Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dosethe amount of medication taken of trial medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Note: In the event that 72 hours have elapsed between the screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for the participant to start receiving study medication.
– A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) as defined in Appendix 1 OR A WOCBP who agrees to use an adequate method of contraception during the treatment period and for at least 120 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant.
– The participant (or legally acceptable representative if applicable) must be willing and able to provide written informed consent for the trial. The participant may also provide consent for Future Biomedical Research. However the participant may participate in the main trial without participating in Future Biomedical Research.