At a glance
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Phase 2B Single-site, Open-label, Nonrandomized Study Evaluating the Efficacy of Neoadjuvant Pembrolizumab for Unresectable Stage III and Unresectable Stage IV Melanoma
In Brief
A Phase 2 clinical trial evaluating Pembrolizumab for Unresectable Malignant Neoplasm and 4 related conditions. Completed, enrolled 10 participants across 1 site.
Detailed Summary
This study is being done to see if using the study drug, pembrolizumab, can shrink down melanoma tumors enough so that they will be small enough to cut out, so that there will be no cancer left in the body. Eligible participants include those who have not received any systemic melanoma therapies (i.e. participants do not have to fail ipilimumab or BRAF inhibitor) and those who have failed all available systemic options (if the participant meets other inclusion / exclusion criteria).
Study Details
Timeline
Interventions
At the Treatment Initiation Visit (Baseline/Day 1), subjects will begin treatment with IV pembrolizumab 200 mg infusions every 3 weeks. As in previous pembrolizumab trials, eligible subjects will receive at least 24 weeks of therapy and may receive up to 2 years of pembrolizumab therapy depending on response to treatment.