Last updated on June 2019

Pembrolizumab Compared to Standard of Care Observation in Treating Patients With Completely Resected Stage I-III Merkel Cell Cancer


Brief description of study

This phase III trial studies how well pembrolizumab works compared to standard of care observation in treating patients with stage I-III Merkel cell cancer that has been completely removed by surgery. 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.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To compare overall survival (OS) and recurrence free survival (RFS) as co-primary endpoints across the two arms.

SECONDARY OBJECTIVES:

I. To evaluate adverse events. II. To evaluate distant metastasis free survival (DMFS). III. To evaluate the impact of radiation on clinical outcomes (OS, RFS, DMFS).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients may also undergo standard of care radiation therapy within 14 days of day 1, cycle 1.

ARM B: Patients receive standard of care observation for 17 cycles. Patients may also undergo standard of care radiation therapy within 14 days of day 1, cycle 1.

After completion of study treatment, patients are followed up every 6 months for 5 years.

Clinical Study Identifier: NCT03712605

Find a site near you

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Margaret R Pardee Memorial Hospital

Hendersonville, NC United States
8.5miles
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Recruitment Status: Open


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