General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT0658172

Background Information

To determine if neoadjuvant immunotherapy combined with response-adapted oncologic surgery improves site-reported event-free survival (EF) compared to standard-of-care surgery in resectable stage III/IV CSCC.

For more information, visit: https://clinicaltrials.gov/study/NCT05658172

Offered At

Inova Schar Cancer Institute
A division of Inova Fairfax Hospital
8081 Innovation Park Drive 
Fairfax, VA 22031
Principal Investigator

Jafar Al-Mondhiry, MD

Eligibility Information

  • Definition of Disease
    • Previously untreated or recurrent CSCC
    • Clinical AJCC 8th Edition (head and neck sites) (Appendix I) or UICC (non-head and neck sites) Stage III or IV (Appendix II)
    • Primary tumor site must be in the head and neck cutaneous region, other non-head and neck cutaneous region, or eyelid cutaneous region
    • No mucosal squamous cell carcinoma (vermillion lip, nasal, oral, sinonasal, conjunctival, anogenital).
    • Tumor must be resectable with curative intent. Note: Tumor with bony skull base invasion and/or skull base foramen involvement (T4b) is not eligible.
    • At least 1 lesion that is measure by RECIST 1.1
    • No definitive clinical or radiologic evidence of distant metastatic disease (M1), visceral and/or distant nodal disease.
  • Age ≥18
  • ECOG Performance Status of 0-2

Ineligibility Information

  • A patient cannot be considered eligible for this study unless ALL of the Eligibility Criteria conditions are met.