General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT06295809

Background Information

This study will assess the safety and efficacy of V940 in combination with pembrolizumab as neoadjuvant and adjuvant therapy in participants with resectable LA cSCC as compared to SOC (surgical resection with/without adjuvant RT at investigator's discretion). Participants with clinical complete response, on clinical examination and by imaging and confirmed by negative biopsy, have the option not to undergo surgery, at the investigator's discretion, and will proceed to adjuvant therapy. It is a Phase 2/3 adaptive design study, and Phase 3 expansion will be determined by prespecified Go-No-Go decision.

For more information, please visit: https://clinicaltrials.gov/study/NCT06295809

Offered At

Inova Schar Cancer Institute
A department of Inova Fairfax Medical Campus
8081 Innovation Park Drive
Fairfax, VA 22031
Principal Investigator

Jennifer DeSimone, MD

Eligibility Information

  • The participant must have a histologically confirmed diagnosis of resectable cSCC as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted).
  • Has LA Stage II-IV (M0) cSCC without distant metastases. 
  • cSCC must be amenable to surgery (resectable) with curative intent.
  • Has an FFPE tumor sample available that is suitable for the Next-generation Sequencing (NGS) required for this study. 
  • Is an individual of any sex/gender, at least 18 years of age, at the time of providing the full informed consent.
  • Measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology.
  • Has a life expectancy of >3 months per investigator assessment.
  • Additional eligibility in protocol.
 

Ineligibility Information

  • Has any other histologic type of skin cancer other than invasive cSCC as well as mixed histology, eg, basal cell carcinoma that has not been definitively treated with surgery or radiation, Bowen's disease, MCC, or melanoma.
  • Distant metastatic disease (M1), visceral and/or distant nodal.
  • Received prior treatment with another cancer vaccine.
  •  Received prior radiotherapy to the index lesion (in-field lesion).
  • History of chronic lymphocytic leukemia (CLL).
  • History of CNS metastases and/or carcinomatous meningitis.
  • History of allogeneic tissue/solid organ transplant.
  • Additional exclusions in protocol.