SKIN CANCER: Squamous cell: Adjuvant: KEYNOTE-630

A Phase 3, Randomized, Double-blind, 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)

Title
Merck MK-3475-630 (Squamous cell skin)
Study Title

A Phase 3, Randomized, Double-blind, 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)

Site Link
Malignancy
Skin cancer; squamous cell skin cancer, non-melanoma skin cancer; SCC, cSCC
Stage
Disease Setting
Adjuvant/Curative
Line Of Therapy
Adjuvant
Investigational Agent
Pembrolizumab
Drug Class
PD-1 inhibitor
PI
Ari VanderWalde, MD
Sponsor
Merck Sharp & Dohme Corp
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Has histologically confirmed cutaneous squamous cell carcinoma (cSCC) as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted)
  • Has histologically confirmed LA cSCC with ≥1 high-risk feature(s) as the primary site of malignancy
  • Has undergone complete macroscopic resection of all known cSCC disease with or without microscopic positive margins
  • Has completed adjuvant radiotherapy (RT) for LA cSCC with last dose of RT ≥4 weeks and ≤16 weeks from randomization
  • Has completed at least 50 Gray (Gy) 25 fractions of adjuvant RT for LA cSCC prior to study entry
  • Is disease free as assessed by the investigator with complete radiographic staging assessment ≤28 days from randomization
  • Has provided an archival or newly-obtained tumor tissue sample adequate for Programmed Cell Death Ligand 1 (PD-L1) testing as determined by central laboratory testing
  • ECOG PS 0-1
  • No other histologic type of skin cancer other than invasive cSCC (eg, basal cell carcinoma) that has not been definitively treated with surgery or radiation, Merkel cell carcinoma; or melanoma
  • No prior immunotherapy
  • Must have recovered from all radiation-related toxicities; must have not required corticosteroids; and has not had radiation pneumonitis
  • No active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
  • No known HIV/HBV/HCV
Objective
  • Primary- RFS
  • Secondary- OS, QoL, Safety
Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
Squamous cell skin cancer
Dosing Frequency
Control Agents
Placebo
Study Protocol
Randomized
Yes
X