ClinicalTrials.gg
Active, not recruitingNCT03271372ADAMUpdated Jun 15, 2026

Adjuvant Avelumab in Merkel Cell Cancer

A Phase 3 interventional study of Avelumab and Peripheral Blood Collection in Stage III Merkel Cell Carcinoma AJCC v8, Stage IIIB Merkel Cell Carcinoma AJCC v8 and Stage IIIA Merkel Cell Carcinoma AJCC v8, sponsored by University of Washington. Active, not recruiting at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by University of Washington · Phase 3, Interventional, and Treatment

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Phase
Phase 3
Study type
Interventional
Enrollment
101
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 112 studies in Carcinoma, Merkel Cell with a site in United States — 27 open to participants now, 47 under way, 3 of them phase 3. Carcinoma, Merkel Cell · United States.

Enrollment
24th of 105
101 · median 40
Started
2017
with 8 others
Phase 3
4 of 112
none open now
Primary completion
2029-01
later than 36 of 46 live
Registered
37th of 112
by date

Among the 112 studies in Carcinoma, Merkel Cell with a site in United States, this one is the 24th largest by enrollment of the 105 interventional ones that give a count, is one of 9 that started in 2017, is one of 4 in phase 3, reaches primary completion later than 36 of the 46 other live ones, and was the 37th registered.

Carcinoma, Merkel Cell

150 studies on the registry are indexed under Carcinoma, Merkel Cell; 40 are open to participants now.

Browse Carcinoma, Merkel Cell studies →

Open to participants now

27 of the 112 studies in Carcinoma, Merkel Cell with a site in United States are open now. Recruiting first, the newest first:

22 more — sign in →

All 27 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 34 Carcinoma, Merkel Cell studies recruiting now, 27 (79%) set no upper age limit and none (0%) stop at 75 or younger; 5 take children under 18; 1 takes healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

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.

Read the detailed description

OUTLINE:

Patients are randomized to 1 of 2 arms.

ARM I: Patients receive avelumab intravenously (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.

ARM II: 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.

After completion of study treatment, patients are followed up every 6 months for 5 years from day 1 and then once every 12 months until the study is terminated by the sponsor.

03

Conditions studied

  • Stage III Merkel Cell Carcinoma AJCC v8
  • Stage IIIB Merkel Cell Carcinoma AJCC v8
  • Stage IIIA Merkel Cell Carcinoma AJCC v8
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • confirmed MCC in regional lymph node(s)

    • Confirmation of the MCC diagnosis in the regional lymph node(s) is mandatory for trial participation
    • (NOTE: In-transit metastases without regional nodal involvement could be allowed, but only after written approval of the medical monitor)
  • Must have completed definitive treatment for primary MCC and regional lymphatic metastases that included surgical removal (with/without radiation therapy) or primary radiation therapy as determined by the treating investigator
  • Aged >= 18 years. Both men and women, and members of all races and ethnic groups are eligible for this trial.
  • Estimated greater than 3 years
  • 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)
  • Eastern Co-Operative Group ( [ECOG]) performance score of 0 or 1
  • (ANC) ≥ 1.5 x 10\^9/L
  • count ≥ 100 x 10\^9/L
  • ≥ 9 g/dL (may have been transfused)
  • Total level ≤ 1.5 x the (ULN) range
  • (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 x ULN
  • Estimated ≥ 30 mL/min according to the Cockcroft-Gault formula or by 24-hour urine collection for creatinine clearance or according to local institutional standard
  • Women of must have a negative serum or urine pregnancy test at screening
  • Both male and female subjects must be willing to use highly effective (that is, methods with a failure rate of less than 1% per year) throughout the study and for at least 30 days after last avelumab treatment administration if the risk of conception exists

    * (NOTE: The effects of the study treatment on the developing human fetus are unknown; thus, women of childbearing potential and men must agree to use highly effective contraception, as stipulated in national or local guidelines. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the treating physician should be informed immediately.)

  • Must have an ability to understand and the willingness to sign a written document
  • Must consent to allow the acquisition of existing formalin-fixed paraffin-embedded (FFPE) tumor tissue, either a block or unstained slides, for performance of correlative studies

Exclusion criteria

Exclusion Criteria:

  • Clinical or radiologic suspicion of residual MCC at the time of enrollment
  • Suspicion or known history of distant MCC, which is not classifiable as local recurrence or regional metastasis
  • Any prior systemic therapy (e.g. adjuvant, or concurrent use of chemotherapy, immunotherapy or an agent) for MCC at any time
  • Any prior intra-lesional MCC therapy within 180 days from day 1 of study treatment
  • Residual toxicity from prior therapy grade > 1 (National Cancer Institute [NCI]- [NCI-CTCAE v 5.0]) that could interfere with study endpoints or put patient safety at risk
  • 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

    * (NOTE: Exception will be made for adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ [skin, bladder, cervical, colorectal, breast] or low grade prostatic intraepithelial neoplasia or Grade 1 prostate cancer; any other neoplasm, which is adjudged by the treating investigator to have a low risk of recurrence during the study, could be enrolled only after written approval from the medical monitor)

  • Use of any systemic treatments including , cyclosporine, mycophenolate mofetil et cetera, ongoing or within the last 3 months prior to day 1 of treatment

    * (NOTE: Patients on physiologic dose of corticosteroids [≤ 10 mg/day of prednisone or equivalent] for long-term hormone-replacement therapy or those requiring short, intermittent courses of corticosteroids for prophylaxis [such as for iodinated computed tomography (CT) contrast prophylaxis] or those using intranasal, inhaled, topical steroids, or local steroid injection [e.g., intra-articular injection] can be allowed)

  • Immunosuppressed status due to known (HIV) infection, severe uncontrolled diabetes, concurrent hematological , or other comorbidities
  • Uncontrolled intercurrent illness including, but not limited to, active serious infection, active or infection, uncontrolled seizure disorder, substance abuse disorder, or psychiatric illness/social situations that would limit compliance with study requirements or would put the patient at increased risk of complications during the study period
  • (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ Classification Class II), or serious cardiac arrhythmia requiring medication
  • Active or history of any serious disease, prior organ transplantation, including stem-cell transplantation or immune-deficiencies that required treatment with systemic immunosuppressive drugs and could flare-up during study treatment

    * (NOTE: Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible)

  • Other severe acute or chronic medical conditions including immune-mediated colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
  • Known prior severe hypersensitivity to investigational product or any component in its formulations that could interfere with study endpoints or put patient safety at risk
  • Pregnant or breast-feeding women
Terms in these criteria, in plain language(28)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
101 participants (actual)

Study arms

  • Experimental
    Arm I (avelumab)

    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.

    Drug: Avelumab · Other: Peripheral Blood Collection

  • Placebo comparator
    Arm II (placebo)

    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.

    Other: Peripheral Blood Collection · Other: Placebo

Interventions

  • Given IV

    Also known as: Bavencio, MSB-0010718C, MSB0010718C

  • OtherPeripheral Blood Collection

    Correlative studies

  • OtherPlacebo

    Given IV

    Also known as: placebo therapy, PLCB, normal saline solution

06

What researchers measure

Primary outcomes

  1. Relapse-free survival

    The Kaplan-Meier technique will be used to obtain estimates.

    Time frame: From the date of randomization and the date of first recurrence or death (whatever the cause), whichever occurs first, assessed for up to 5 years

Secondary outcomes

  1. Overall survival

    The Kaplan-Meier technique will be used to obtain estimates.

    Time frame: From the date of randomization and the date of death, assessed for up to 5 years then every 12 months after study drug discontinued

  2. Disease-specific survival

    Cumulative incidence estimates will be used to summarize the probabilities of disease-specific survival.

    Time frame: From the date of randomization and the date of death from Merkel cell carcinoma, assessed for up to 5 years

  3. Distant-metastases free survival

    The Kaplan-Meier technique will be used to obtain estimates.

    Time frame: From the date of randomization and the date of first distant metastasis or date of death (any cause), whichever occurs first, assessed for up to 5 years

  4. Incidence of adverse events

    Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.

    Time frame: Throughout the duration of the treatment (up to 2 years after randomization)

Other outcomes

  1. AMERK serology

    Blood test to predict recurrence in those patients who had a positive titer at baseline.

    Time frame: Up to 5 years

  2. Biomarker exploration in tumor and peripheral blood samples

    Tumor and peripheral blood samples.

    Time frame: Up to 5 years

07

Study locations

9 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2017 (actual). Primary completion is estimated for Jan 2029, 133 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2017
First posted
Sep 5, 2017
StartActual
Dec 19, 2017
Primary completionEst.
Jan 31, 2029
CompletionEst.
Feb 18, 2029
Last update
Jun 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03271372
Collaborators
EMD Serono
Responsible party
Sponsor
First posted
Sep 5, 2017
Start date
Dec 19, 2017
Primary completion
Jan 31, 2029 (estimated)
Completion
Feb 18, 2029 (estimated)
Last update
Jun 15, 2026

Study contacts

Shailender Bhatia
principal investigator · Fred Hutch/University of Washington Cancer Consortium

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Avelumab

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