101 Participants Needed

Avelumab for Merkel Cell Carcinoma

(ADAM Trial)

Recruiting at 9 trial locations
AT
Overseen ByADAM Trial Coordinator
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

Avelumab, also known as Bavencio, has been studied for safety in treating metastatic Merkel cell carcinoma. It is generally considered to have an acceptable safety profile, though it can cause immune-related side effects, which are manageable.12367

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

SB

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

Your hemoglobin level is at least 9 grams per deciliter.
I will begin the study treatment within 120 days after my definitive cancer therapy started.
Your platelet count is at least 100 billion per liter.
See 13 more

Exclusion Criteria

Pregnant or breast-feeding women
I have an autoimmune disease or had an organ transplant that needed strong immune system drugs.
Doctors suspect I still have Merkel cell carcinoma after initial checks.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Phase 1

Patients receive avelumab or placebo IV over 1 hour once every 15 days

16 weeks
8 visits (in-person)

Induction Phase 2

Patients receive avelumab or placebo IV over 1 hour once every 30 days

16 weeks
4 visits (in-person)

Maintenance Phase

Patients receive avelumab or placebo IV over 1 hour once every 120 days

24 months
6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years
Every 6 months for 5 years, then annually

Treatment Details

Interventions

  • Avelumab
Trial Overview The study tests if Avelumab, an immunotherapy drug using monoclonal antibodies, can prevent MCC from returning after initial treatment. Patients are randomly assigned to receive either Avelumab or a placebo following their primary therapy. The trial also involves collecting blood samples for further research.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (avelumab)Experimental Treatment2 Interventions
Patients receive avelumab 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.
Group II: Arm II (placebo)Placebo Group2 Interventions
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

EMD Serono

Industry Sponsor

Trials
147
Recruited
27,800+
Dr. Shepard profile image

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

Findings from Research

Avelumab is a monoclonal antibody that effectively treats metastatic Merkel cell carcinoma (MCC), showing an objective response rate of 31.8% in a phase II trial with 88 previously treated patients, including 10 complete responses.
The treatment demonstrated a median overall survival of 12.9 months and a 1-year progression-free survival rate of 30%, with manageable side effects, making it a promising alternative to traditional chemotherapy for MCC.
Avelumab: A Review of Its Application in Metastatic Merkel Cell Carcinoma.Joseph, J., Zobniw, C., Davis, J., et al.[2020]
Avelumab is the first approved treatment specifically for metastatic Merkel cell carcinoma (MCC), showing significant efficacy with about one-third of chemotherapy-refractory patients responding positively, and 74% of these responses lasting at least 12 months.
In a separate cohort of chemotherapy-naïve patients, avelumab demonstrated an impressive objective response rate of over 60%, while maintaining a manageable safety profile despite some risk of immune-related adverse events.
Avelumab: A Review in Metastatic Merkel Cell Carcinoma.Shirley, M.[2020]
In a phase II trial involving 116 patients with metastatic Merkel cell carcinoma (mMCC), first-line treatment with avelumab resulted in a 39.7% objective response rate and a 30.2% durable response rate, indicating its efficacy in this aggressive skin cancer.
The treatment was generally well-tolerated, with 81% of patients experiencing treatment-related adverse events, but only 18.1% had severe (grade 3/4) events, and there were no treatment-related deaths, highlighting its safety profile.
First-line avelumab in a cohort of 116 patients with metastatic Merkel cell carcinoma (JAVELIN Merkel 200): primary and biomarker analyses of a phase II study.D'Angelo, SP., Lebbé, C., Mortier, L., et al.[2022]

References

Avelumab: A Review of Its Application in Metastatic Merkel Cell Carcinoma. [2020]
Avelumab: A Review in Metastatic Merkel Cell Carcinoma. [2020]
First-line avelumab in a cohort of 116 patients with metastatic Merkel cell carcinoma (JAVELIN Merkel 200): primary and biomarker analyses of a phase II study. [2022]
Avelumab in patients with previously treated metastatic Merkel cell carcinoma: long-term data and biomarker analyses from the single-arm phase 2 JAVELIN Merkel 200 trial. [2021]
Avelumab for advanced Merkel cell carcinoma in the Netherlands: a real-world cohort. [2021]
Avelumab for Advanced Merkel Cell Carcinoma: Global Real-World Data on Patient Response and Survival. [2023]
Efficacy and safety of avelumab treatment in patients with metastatic Merkel cell carcinoma: experience from a global expanded access program. [2023]
Severe Demyelinating Polyneuropathy and Cranial Neuropathy During Avelumab Treatment of Metastatic Merkel Cell Carcinoma. [2021]
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