MELANOMA: ADJUVANT: STAGE 2: KEYNOTE-716

Adjuvant Therapy With Pembrolizumab Versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE-716)

Title
Merck MK-3475-716 (Stage II Melanoma)
Study Title

Adjuvant Therapy With Pembrolizumab Versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE-716)

Site Link
Malignancy
Melanoma
Stage
Disease Setting
Adjuvant
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
  • Stage IIB or IIC Melanoma  (T3b, T4a, T4b). Must be node-negative
  • No prior treatment for melanoma beyond complete surgical resection of current primary lesion
  • Must have received sentinel lymph node biopsy which was negative
  • 12 weeks or less from surgical resection and first study treatment
  • No evidence of metastatic disease on imaging
  • ECOG PS 0-1
  • No known additional malignancy within the past 5 years
  • Must have recovered adequately from surgery
  • No active autoimmune disease requiring systemic treatment in the past 2 years
  • No history of non-infectious pneumonitis
  • No known HIV/HBV/HCV
  •  
Objective

Primary- RFS

Secondary- DMFS, OS, Safety

Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
Cutaneous
Dosing Frequency
Control Agents
placebo
Study Protocol
Randomized
Yes
X