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A Phase III Randomized Trial Comparing Adjuvant MK-3475 (Pembrolizumab) to Standard of Care Observation in Completely Resected Merkel Cell Carcinoma

Status
Active
Cancer Type
Skin Cancer (Non-Melanoma)
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03712605
Protocol IDs
EA6174 (primary)
EA6174
NCI-2018-02217
Study Sponsor
ECOG-ACRIN Cancer Research Group

Summary

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.

Objectives

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 courses in the absence of disease progression or unacceptable toxicity. Patients may also undergo standard of care radiation therapy within 14 days of day 1, course 1.

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

After completion of study treatment, patients are followed up every 6 months for 4 years.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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Georgia CORE is a statewide nonprofitthat leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.