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8110 Gatehouse Road, Falls Church, VA 22042

A Phase 3, Randomized, Doubleblind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants with High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-

General Information

Age Group

Adult

Status

Recruiting

Protocol Number

NCT03833167

Background Information

The purpose of this study is to test the safety of the study drug, pembrolizumab, and whether it keeps your type of cancer from coming back or spreading compared to placebo. The purpose of this study is also to see if giving pembrolizumab after surgery and radiation helps patients with your type of cancer live longer.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital

Eligibility Information

  • Participants must be 18 years of age or older
  • Participants must have histologically confirmed cSCC as the primary site of malignancy
  • Participants must have completed adjuvant RT for LA cSCC with last dose of RT ≥4 weeks and ≤16 weeks from randomization
  • Additional eligibility in protocol

Ineligibility Information

  • Participants who have any other histologic type of skin cancer other than invasive cSCC, eg, basal cell carcinoma that has not been definitively treated with surgery or radiation, Bowen’s disease, MCC, melanoma
  • Participants must have recovered from all radiation-related toxicities, not have required corticosteroids, and not have had radiation pneumonitis
  • Has had an allogeneic tissue/solid organ transplant
  • Additional ineligibility in protocol

For more information go to: https://clinicaltrials.gov/ct2/show/NCT03833167