A Tissue Collection Study of Pembrolizumab (MK-3475) in Subjects With Resectable Advanced Melanoma
Summary
The main purpose of this trial is to evaluate the safety, tolerability and adverse event profile of pembrolizumab in subjects who have high risk melanoma before and after their standard of care surgical resection, and to collect tumor tissue from subjects before and after receipt of pembrolizumab to look at how the experimental drug interacts with tumor tissue. Subjects will receive 1 dose of neoadjuvant pembrolizumab, followed by complete resection and then a year of adjuvant pembrolizumab
Timeline
- Start
- 2015-04
- Primary completion
- 2019-07
- Completion
- 2021-09-29
Outcome
Mixed primary results
paper The primary outcomes were 5-year overall survival (OS), 5-year recurrence-free survival (RFS), and recurrence patterns. PMID 37414215 ↗
paper No deaths occurred in patients with a major pathological response (MPR, <10% viable tumor) or complete pathological response (pCR, no viable tumor) (n = 8), compared to a 5-year OS of 72.8% for the remainder of the cohort (P = 0.12). PMID 37414215 ↗
paper Additionally, the median time to recurrence was 3.9 years for patients with ≤10% viable tumor and 0.6 years for patients with >10% viable tumor (P = 0.044). PMID 37414215 ↗
Publications
- Results Huang AC, Orlowski RJ, Xu X, Mick R, George SM, Yan PK, Manne S, Kraya AA, Wubbenhorst B, Dorfman L, D'Andrea K, Wenz BM, Liu S, Chilukuri L, Kozlov A, Carberry M, Giles L, Kier MW, Quagliarello F, McGettigan S, Kreider K, Annamalai L, Zhao Q, Mogg R, Xu W, Blumenschein WM, Yearley JH, Linette GP, Amaravadi RK, Schuchter LM, Herati RS, Bengsch B, Nathanson KL, Farwell MD, Karakousis GC, Wherry EJ, Mitchell TC. A single dose of neoadjuvant PD-1 blockade predicts clinical outcomes in resectable melanoma. Nat Med. 2019 Mar;25(3):454-461. doi: 10.1038/s41591-019-0357-y. Epub 2019 Feb 25.
- Sharon CE, Tortorello GN, Ma KL, Huang AC, Xu X, Giles LR, McGettigan S, Kreider K, Schuchter LM, Mathew AJ, Amaravadi RK, Gimotty PA, Miura JT, Karakousis GC, Mitchell TC. Long-term outcomes to neoadjuvant pembrolizumab based on pathological response for patients with resectable stage III/IV cutaneous melanoma. Ann Oncol. 2023 Sep;34(9):806-812. doi: 10.1016/j.annonc.2023.06.006. Epub 2023 Jul 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |