This pilot phase II trial studies how well pembrolizumab works in treating patients with
desmoplastic melanoma (DM) that can be removed by surgery (resectable) or cannot be removed
by surgery (unresectable). 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.
I. To evaluate the pathologic complete response rate (pCR) in patients with resectable
desmoplastic melanoma treated with neoadjuvant MK-3475 (pembrolizumab). (Cohort A) II. To
evaluate the complete response rate (confirmed and unconfirmed) in patients with unresectable
desmoplastic melanoma treated with MK-3475 (pembrolizumab). (Cohort B)
I. To estimate the 9 week response rate (RR) (unconfirmed complete and partial responses)
among patients with measurable disease. (Cohort A) II. To estimate the median overall
survival (OS). (Cohort A) III. To evaluate safety and tolerability of MK-3475 (pembrolizumab)
in the neoadjuvant setting. (Cohort A) IV. To estimate the median progression-free survival
(PFS). (Cohort B) V. To estimate the median overall survival (OS). (Cohort B) VI. To evaluate
safety and tolerability of MK-3475 (pembrolizumab) in this setting. (Cohort B)
I. To evaluate the hypothesis that higher mutational load in the patient derived baseline
tumor biopsy samples is associated with higher pathologic complete response (pCR).
II. To evaluate T cell infiltration into the tumors in DM patients and correlate with
response to programmed cell death protein 1 (PD-1) blockade.
III. To evaluate the clonality of tumor infiltrating T cells in DM patients and correlate
with response to PD-1 blockade.
IV. To evaluate adaptive immune resistant mechanism in DM tumors.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT A: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1.
Treatment repeats every 21 days for up to 3 cycles. Patients with potentially resectable
disease undergo surgery. Patients with tumor progression and unresectable disease may receive
one additional cycle of pembrolizumab.
COHORT B: Patients with unresectable disease receive pembrolizumab IV over 30 minutes on day
Treatment repeats every 21 days for up to 34 cycles in the absence of disease progression
After completion of study treatment, patients are followed up at 6 and 12 weeks, then every 3
months for 1 year, and every 6 months for 4 years.
laboratory biomarker analysis,
therapeutic conventional surgery
Clinical Study Identifier
National Cancer Institute (NCI)
Last Modified on
26 November 2020
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