Avelumab for Merkel Cell Carcinoma
(ADAM Trial)

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen byShailender Bhatia, MBBS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: University of Washington

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

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.

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 14 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.

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Treatment Details

Interventions

Avelumab (Monoclonal Antibodies)

Trial OverviewThe 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.