J18109 - Adjuvant Therapy with Pembrolizumab versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE 716)
Johns Hopkins Kimmel Cancer Center in Baltimore
This trial will examine whether the benefits achieved with pembrolizumab adjuvant therapy seen in Stage III and IV melanoma translates to the adult ( equal to 18 years of age) and pediatric (age 12 and older) High Risk Stage II melanoma populations,and leads to improved RFS, DMFS and OS, while identifying biomarker correlates. Tolerable AEs are expected in an otherwise untreated population, making this an ideal design in which to include pediatric and adult participants. Upon recurrence, this trial will explore whether re-challenge with pembrolizumab after adjuvant therapy decreases the risk of another recurrence or disease progression.
Participants must be at least 12 years I age. Must have had surgery post new diagnosis of Stage IIB or IIC cutaneous melanoma.No evidence of metastatic disease. ECOG 0-1Must be recovered from surgery. Good organ function. No known malignancy that has required treatment in the past 5 years. Chronic steroid therapy not allowed. no immunodeficiencies allowed. No pregnant women. No prior systemic anti-cancer treatments for melanoma allowed. No prior investigational agents for melanoma.
Part 1 (Adjuvant Treatment) Randomized, Double BlindedPembrolizumab or Placebo every 3 weeks for 17 doses unless disease recurrence or a non-tolerated adverse event should occur. Participants who have disease recurrence will be unblinded. Part 2 Crossover or Re-Challenge
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