Clinical Trial

Neoadjuvant PD-1 Blockade in Patients with Stage IIB/C Melanoma

Active, Not Recruiting Phase 2
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Summary
The main purpose of this study is to determine the rate of positive sentinel lymph nodes (i.e. the closest draining lymph node(s) to the primary melanoma site) and to test whether treatment with pembrolizumab before surgery to remove melanoma reduces the rate of positive sentinel lymph nodes in patients with Stage IIB/C melanoma. Subjects with stage II melanoma will receive one dose of pembrolizumab 200 mg, then undergo standard definitive surgery with wide excision and sentinel lymph node (SLN) biopsy approximately 3 weeks after the initial dose of pembrolizumab. Post-operatively, subjects will receive up to 1 year of adjuvant pembrolizumab 200 mg every 3 weeks.
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2018-11-27; most recent amendment 2025-02-07.
Status change: Recruiting → Active, Not Recruiting 2024-07-30
Status change: Active, Not Recruiting → Recruiting 2020-07-10
Status change: Recruiting → Active, Not Recruiting 2020-03-24
Status change: Not Yet Recruiting → Recruiting 2019-04-08
Trial Details
NCT Number NCT03757689
Lead Sponsor Abramson Cancer Center at Penn Medicine
Conditions Melanoma
Enrollment 63 participants
Start Date 2019-05-06
Primary Completion 2024-12-01 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2025-02-11