This randomized phase III trial studies how well avelumab works in treating patients with Merkel cell cancer that has spread to the lymph nodes and have undergone surgery and/or radiation therapy. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive avelumab intravenously (IV) over 1 hour once every 15 days for the first 120 days (Induction Phase 1), once every 30 days for the next 120 days (Induction Phase 2), and then once every 120 days (Maintenance Phase) for a maximum of 720 days (approximately 24 months or 2 years total) in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive placebo IV over 1 hour once every 15 days for the first 120 days (Induction Phase 1), once every 30 days for the next 120 days (Induction Phase 2), and then once every 120 days (Maintenance Phase) for a maximum of 720 days (approximately 24 months or 2 years total) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 5 years from day 1 and then once every 12 months until the study is terminated by the sponsor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
101
University of California Irvine Chao Family Comprehensive Cancer Center
Orange, California, United States
University of Colorado Cancer Center University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Moffitt Cancer Center
Tampa, Florida, United States
Relapse-free survival
The Kaplan-Meier technique will be used to obtain estimates.
Time frame: From the date of randomization and the date of first recurrence or death (whatever the cause), whichever occurs first, assessed for up to 5 years
Overall survival
The Kaplan-Meier technique will be used to obtain estimates.
Time frame: From the date of randomization and the date of death, assessed for up to 5 years then every 12 months after study drug discontinued
Disease-specific survival
Cumulative incidence estimates will be used to summarize the probabilities of disease-specific survival.
Time frame: From the date of randomization and the date of death from Merkel cell carcinoma, assessed for up to 5 years
Distant-metastases free survival
The Kaplan-Meier technique will be used to obtain estimates.
Time frame: From the date of randomization and the date of first distant metastasis or date of death (any cause), whichever occurs first, assessed for up to 5 years
Incidence of adverse events
Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.
Time frame: Throughout the duration of the treatment (up to 2 years after randomization)
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Northwestern University
Chicago, Illinois, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States