Avelumab for Merkel Cell Carcinoma
(ADAM Trial)
Trial Summary
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop your current medications, but you cannot use systemic immunosuppressive treatments like corticosteroids within 3 months before starting the trial. If you're on a low dose of corticosteroids for hormone replacement or short-term use, you might still be eligible.
What data supports the effectiveness of the drug Avelumab for treating Merkel Cell Carcinoma?
Avelumab has been shown to be effective in treating metastatic Merkel cell carcinoma, with about one-third of patients who had previously received chemotherapy experiencing significant tumor shrinkage. Additionally, more than 60% of patients who had not received prior chemotherapy also responded well to the drug, with many of these responses lasting at least a year.12345
Is avelumab safe for humans?
How is the drug avelumab different from other treatments for Merkel cell carcinoma?
Avelumab is unique because it is the first drug specifically approved for treating metastatic Merkel cell carcinoma, working as an immune checkpoint inhibitor by blocking PD-L1, which helps the immune system attack cancer cells. Unlike traditional chemotherapy, avelumab can provide durable responses and is used regardless of previous treatments.12678
What is the purpose of this trial?
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.
Research Team
Shailender Bhatia, MBBS
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Eligibility Criteria
This trial is for adults with Merkel Cell Carcinoma (MCC) that has spread to lymph nodes, treated with surgery and/or radiation. Participants must have completed treatment within the last 120 days, be in good health with a life expectancy over 3 years, and not have any serious illnesses or immune system problems. They should agree to use effective contraception and provide consent for tissue sample collection.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction Phase 1
Patients receive avelumab or placebo IV over 1 hour once every 15 days
Induction Phase 2
Patients receive avelumab or placebo IV over 1 hour once every 30 days
Maintenance Phase
Patients receive avelumab or placebo IV over 1 hour once every 120 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Avelumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
EMD Serono
Industry Sponsor
Dr. Shepard
EMD Serono
Chief Medical Officer since 2021
MD from University of Cincinnati Medical School, Fellowships in Hematology and Oncology at University of Chicago Hospitals and Clinics
Miguel Fernández Alcalde
EMD Serono
Chief Executive Officer
Bachelor's Degree in Pharmacy from the University Complutense in Madrid, MBA from the University of Alcalá de Henares, Master's Degree in Management from IESE Business School