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Avelumab for Merkel Cell Carcinoma (ADAM Trial)

Phase 3

Waitlist Available

Led By Shailender Bhatia

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have completed definitive treatment for primary MCC and regional lymphatic metastases that included surgical removal (with/without adjuvant radiation therapy) or primary radiation therapy as determined by the treating investigator

Histologically confirmed MCC metastases in regional lymph node(s)

Must not have

Clinical or radiologic suspicion of residual MCC at the time of enrollment

Previous malignant disease (other than Merkel cell carcinoma) diagnosed within 3 years from day 1 of study treatment that could interfere with study endpoints or put patient safety at risk

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing avelumab to see if it can help treat patients with Merkel cell cancer that has spread to the lymph nodes.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Avelumab may cause side effects like fatigue, infusion reactions where the drug enters the body, skin issues, muscle or joint pain, immune-related conditions such as inflammation of organs like intestines or lungs (colitis/pneumonitis), thyroid disorders and potential risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have finished all initial treatments for Merkel Cell Carcinoma, including surgery or radiation.

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My Merkel cell carcinoma has spread to my lymph nodes.

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My kidneys are functioning well enough, with a creatinine clearance of at least 30 mL/min.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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Doctors suspect I still have Merkel cell carcinoma after initial checks.

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I haven't had any cancer other than Merkel cell carcinoma in the last 3 years.

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I have a condition like HIV, severe diabetes, or another serious illness that weakens my immune system.

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I have an active heart condition.

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I do not have severe side effects from previous treatments.

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My cancer has spread far from where it started and is not just a local recurrence.

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I have received treatment for Merkel cell carcinoma before.

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I do not have any serious ongoing illnesses that could interfere with the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Relapse-free survival

Secondary study objectives

Disease-specific survival

Neoplasm Metastasis

Incidence of adverse events

+1 more

Other study objectives

AMERK serology

Biomarker exploration in tumor and peripheral blood samples

Side effects data

From 2020 Phase 2 trial • 19 Patients • NCT03006848

17%

Musculoskeletal and connective tissue disorders

11%

Injury, poisoning and procedural complications

Endocrine disorders

General disorders and administration site conditions

Metabolism and nutrition disorders

Nervous system disorders

Investigations

Cardiac disorders

Gastrointestinal disorders

Infections and infestations

Immune system disorders

Blood and lymphatic system disorders

Respiratory, thoracic and mediastinal disorders

Neoplasms benign, malignant and unspecified

Renal and urinary disorders

Skin and subcutaneous tissue disorders

100%

80%

60%

40%

20%

Study treatment Arm

Avelumab

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Avelumab

2017

Completed Phase 2

~2440

0 / 12Eligibility criteria met