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This phase II trial studies how pembrolizumab works before and after surgery in treating
patients with stage III-IV high-risk melanoma. Immunotherapy with monoclonal antibodies, such
as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with
the ability of tumor cells to grow and spread. Giving pembrolizumab before and after surgery
may work better compared to after surgery alone in treating melanoma.
I. To compare event-free survival (EFS) in patients with high-risk resectable melanoma
randomized to neoadjuvant MK-3475 (pembrolizumab) with patients randomized to adjuvant
I. To assess the frequency and severity of toxicities on each of the arms. II. To compare
between arms overall survival (OS), disease control at 24 weeks, locoregional control in the
surgical site(s), and total number of MK-3475 (pembrolizumab) doses received.
III. On the neoadjuvant arm, to estimate the pathologic response rate, the Response
Evaluation Criteria in Solid Tumors (RECIST) 1.1 response rate (confirmed and unconfirmed
complete response [CR] and partial response [PR]), and the immune-related (i)RECIST response
rate (confirmed and unconfirmed CR and PR), before surgical resection; to compare definitions
of pathologic partial response; and to evaluate the association between pathologic response
and EFS and OS.
IV. To describe the proportion of patients on each arm who received the surgery planned at
I. To bank tumor tissue and whole blood in anticipation of future correlative studies in this
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Within 84 days after surgical resection, patients receive pembrolizumab intravenously
(IV) over 30 minutes on day 1. Treatment repeats every 3 weeks for 18 cycles in the absence
of disease progression or unacceptable toxicity.
ARM II: Patients receive pembrolizumab IV over 30 minutes on day 1 every 3 weeks for 3
cycles, then undergo surgical resection within 3 weeks. Within 84 days, patients receive
pembrolizumab IV over 30 minutes every 3 weeks for 15 cycles in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3 and 12 weeks, then every 3
months for 2 years, every 6 months for 3 years, then every 12 months for up to a total of 10
therapeutic conventional surgery
Clinical Study Identifier
National Cancer Institute (NCI)
Last Modified on
23 November 2020
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