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Melanoma / Skin
General Information
Study Name:
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-630)
Age Group:
Adult
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
Contact Information
Contact Name:
Kelly Jeffords, CCRP
Contact Phone:
571-472-0631
Contact Email:
kelly.jeffords@inova.org
For more information go to:
https://clinicaltrials.gov/ct2/show/NCT03776136?term=03776136&rank=1