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Avelumab for Merkel Cell Carcinoma (ADAM Trial)

Phase 3
Recruiting
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 start the study treatment no more than 120 days from the start date of definitive therapy (the date of surgical removal of nodal metastases or the date of initiation of definitive radiation therapy, as applicable)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

ADAM 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.Check my eligibility
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.See study design
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.

ADAM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I will begin the study treatment within 120 days after my definitive cancer therapy started.
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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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My Merkel cell carcinoma diagnosis has been confirmed in the lymph nodes.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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I will use effective birth control during and for 30 days after the study if I can conceive.

ADAM Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Relapse-free survival
Secondary outcome measures
Disease-specific survival
Neoplasm Metastasis
Incidence of adverse events
+1 more
Other outcome measures
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
6%
Gastrointestinal disorders
6%
General disorders and administration site conditions
6%
Metabolism and nutrition disorders
6%
Nervous system disorders
6%
Immune system disorders
6%
Investigations
6%
Cardiac disorders
6%
Endocrine disorders
6%
Blood and lymphatic system disorders
6%
Neoplasms benign, malignant and unspecified
6%
Infections and infestations
6%
Respiratory, thoracic and mediastinal disorders
6%
Renal and urinary disorders
6%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Avelumab

ADAM 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
2018
Completed Phase 2
~2450

Find a Location

Who is running the clinical trial?

EMD SeronoIndustry Sponsor
143 Previous Clinical Trials
27,100 Total Patients Enrolled
University of WashingtonLead Sponsor
1,726 Previous Clinical Trials
1,821,217 Total Patients Enrolled
Shailender BhatiaPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
2 Previous Clinical Trials
35 Total Patients Enrolled

Media Library

Avelumab Clinical Trial Eligibility Overview. Trial Name: NCT03271372 — Phase 3
Merkel Cell Carcinoma Research Study Groups: Arm I (avelumab), Arm II (placebo)
Merkel Cell Carcinoma Clinical Trial 2023: Avelumab Highlights & Side Effects. Trial Name: NCT03271372 — Phase 3
Avelumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT03271372 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Avelumab a danger to patients who take it?

"Avelumab has received a safety score of 3 by our analysts at Power. This is due to the fact that Avelumab is a Phase 3 trial, which suggests that there is available data that supports both its efficacy and safety."

Answered by AI

What is the extent of Avelumab's clinical trial history?

"Avelumab was first studied in 2014 at Helios Klinikum Erfurt. Since then, there have been 18286 completed studies. As of right now, there are 116 active trials, many of which are taking place in Tampa, Florida."

Answered by AI

How many human test subjects are taking part in this experiment?

"One hundred study participants that fit the bill are necessary for this trial to happen. EMD Serono, the trial's sponsor, will carry out the experiment at various research facilities; two notable locations are Moffitt Cancer Center in Tampa, Florida and Seattle Cancer Care Alliance in Seattle, Washington."

Answered by AI

Is this study being conducted at more than one location within the US?

"Right now, this experiment is being conducted at 10 different sites. If you are considering enrolling, please choose the location nearest to you to limit travel as much as possible. The 10 sites are located in Tampa, Seattle, New york and other cities."

Answered by AI

Are there any similar trials to compare this one to?

"There are over a hundred ongoing trials for Avelumab in cities worldwide. The first trial began in 2014 and, after Phase 2 approval, involved 204 people. Since then, there have been 18286 completed studies."

Answered by AI
~17 spots leftby Jul 2025