NCT03757689

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pre-Surgery: Pembrolizumab, one 200mg dose; Post-Surgery: Pembrolizumab, 200 mg every 3 weeks.
PROCEDURE	Wide Excision and Sentinel Lymph Node (SLN) Biopsy	Wide excision and SLN biopsy and pathologic assessment of tissue will be performed per standard of care.

Timeline

• Start date: 2019-05-06
• Primary completion: 2024-12-01
• Completion: 2027-02-01
• First posted: 2018-11-29
• Last updated: 2025-02-11

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study