Actively Recruiting
Neoadjuvant Pembrolizumab in Cutaneous Squamous Cell Carcinoma
Led by Queensland Health · Updated on 2022-08-01
27
Participants Needed
3
Research Sites
257 weeks
Total Duration
On this page
Sponsors
Q
Queensland Health
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Cutaneous Squamous Cell Carcinoma (cSCC) is typically associated with a high tumour 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 resection has multiple potential advantages, including: 1. Reduction in surgical and radiotherapy morbidity by reducing tumour burden and allowing the appropriate selection of patients to undergo post-operative radiotherapy; 2. Provision of immediate information about pathological response and 3. Access to tissue 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.
CONDITIONS
Official Title
Neoadjuvant Pembrolizumab in Cutaneous Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed invasive cSCC that is locally advanced (Stage II-IV on AJCC 8th edition) and considered high risk requiring post-operative radiotherapy
- Candidate for complete surgical resection
- Measurable disease based on RECIST 1.1 criteria
- ECOG performance status of 0 to 1 within 10 days before treatment start
- Adequate organ function
- Tissue sample available for research from biopsy
- Life expectancy over 6 months
- At least 18 years old at informed consent signing
- Female participants of childbearing potential must have negative pregnancy test within 72 hours before first treatment dose and agree to contraception use during and 120 days after treatment
- Willing and able to provide written informed consent
You will not qualify if you...
- Metastatic or unresectable cSCC not curable by surgery or radiotherapy
- Other types of skin cancer as primary disease (e.g., basal cell carcinoma untreated, Bowen's disease, Merkel cell carcinoma, melanoma)
- Prior allogeneic solid organ or stem cell transplant
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or similar immune agents
- Previous systemic anti-cancer therapy for cSCC
- Prior radiotherapy to target lesion
- Live vaccine within 30 days before first treatment dose
- Participation in investigational trials or use of investigational devices within 4 weeks prior to treatment
- Active or recent serious autoimmune disease requiring systemic immunosuppressive treatment
- Immunodeficiency disorders or current systemic steroid/immunosuppressive therapy exceeding defined limits
- Diagnosis or treatment for another malignancy within past 3 years, with specified exceptions
- Active autoimmune disease requiring systemic treatment in past 2 years
- History of pneumonitis needing steroids or current pneumonitis
- Active infection requiring systemic therapy
- Known active Hepatitis B or C infection
- Psychiatric or substance abuse disorders interfering with trial participation
- Pregnant, breastfeeding, or intending to conceive/father children during trial and 120 days after last dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
2
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Actively Recruiting
3
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
Research Team
R
Rahul Ladwa, MD
CONTACT
K
Kym Bessell
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here