West Cancer Center

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

NCT03553836

Malignancy

Melanoma

Stage

Stage 2

Disease Setting

Adjuvant

Line Of Therapy

Adjuvant

Investigational Agent

Pembrolizumab

Drug Class

PD-1 inhibitor

Ari VanderWalde, MD

Sponsor

Merck Sharp & Dohme Corp.

Phase

Phase 3

Status

Closed to Accrual

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