Stage III Merkel Cell Carcinoma AJCC v8Phase 3ADAMNCT03271372
Adjuvant Avelumab in Merkel Cell Cancer
A Phase 3 study testing Avelumab and Peripheral Blood Collection in people with Stage III Merkel Cell Carcinoma AJCC v8 and Stage IIIB Merkel Cell Carcinoma AJCC v8, run by University of Washington at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage III Merkel Cell Carcinoma AJCC v8, Stage IIIB Merkel Cell Carcinoma AJCC v8, Stage IIIA Merkel Cell Carcinoma AJCC v8
- What is being tested?
- Avelumab and Peripheral Blood Collection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 9 sitesUnited States
- Study dates
- 19 Dec 2017to 18 Feb 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed MCC metastases 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 adjuvant 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 life expectancy greater than 3 years
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- 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 (Eastern Cooperative Oncology Group [ECOG]) performance score of 0 or 1
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
- Platelet count ≥ 100 x 10^9/L
- Hemoglobin ≥ 9 g/dL (may have been transfused)
- Total bilirubin level ≤ 1.5 x the upper limit of normal (ULN) range
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 x ULN
- Estimated creatinine clearance ≥ 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 childbearing potential must have a negative serum or urine pregnancy test at screening
- Both male and female subjects must be willing to use highly effective contraception (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 informed consent 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
Who cannot join
- Clinical or radiologic suspicion of residual MCC at the time of enrollment
- Suspicion or known history of distant metastatic MCC, which is not classifiable as local recurrence or regional metastasis
- Any prior systemic therapy (e.g. adjuvant, neo-adjuvant or concurrent use of chemotherapy, immunotherapy or an investigational 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]-Common Terminology Criteria for Adverse Events [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
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- (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 immunosuppressive treatments including corticosteroids, 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 hypersensitivity 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 human immunodeficiency virus (HIV) infection, severe uncontrolled diabetes, concurrent hematological malignancy, or other comorbidities
- Uncontrolled intercurrent illness including, but not limited to, active serious infection, active hepatitis B or hepatitis C 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
- Clinically significant (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 (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication
- Active or history of any serious autoimmune disease, prior organ transplantation, including allogeneic 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
University of Colorado Cancer Center University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Northwestern University
Chicago, Illinois, 60611
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of California Irvine Chao Family Comprehensive Cancer Center
Orange, California, 92868
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: A Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Phase 3 Trial of Adjuvant Avelumab (Anti-PDL-1 Antibody) in Merkel Cell Carcinoma Patients With Lymph Node Metastases
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.
- Conditions
- Stage III Merkel Cell Carcinoma AJCC v8, Stage IIIB Merkel Cell Carcinoma AJCC v8, Stage IIIA Merkel Cell Carcinoma AJCC v8
- Being tested
- Avelumab, Peripheral Blood Collection, Placebo
- Medical subject headings
- Carcinoma, Merkel Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvelumabDrug
Also called Bavencio, MSB-0010718C, MSB0010718C
Given IV
Peripheral Blood CollectionOther
Correlative studies
PlaceboOther
Also called placebo therapy, PLCB, normal saline solution
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I (avelumab) | Experimental | 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. Receives: Drug: Avelumab; Other: Peripheral Blood Collection |
| Arm II (placebo) | Placebo comparator | 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. Receives: Other: Peripheral Blood Collection; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free survival
The Kaplan-Meier technique will be used to obtain estimates.
Measured: 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 (4)
Overall survival
The Kaplan-Meier technique will be used to obtain estimates.
Measured: From the date of randomization and the date of death, assessed for up to 5 years then every 12 months after study drug discontinued
Disease-specific survival
Cumulative incidence estimates will be used to summarize the probabilities of disease-specific survival.
Measured: From the date of randomization and the date of death from Merkel cell carcinoma, assessed for up to 5 years
Distant-metastases free survival
The Kaplan-Meier technique will be used to obtain estimates.
Measured: 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
Incidence of adverse events
Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.
Measured: Throughout the duration of the treatment (up to 2 years after randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start19 Dec 2017
- Primary completion31 Jan 2029 (estimated)
- Study completion18 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III Merkel Cell Carcinoma AJCC v8Studies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- EMD Serono
- Responsible party
- Sponsor
- Investigators
- Shailender Bhatia, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271372
- Sponsor's protocol ID
- 9820
- Other IDs
- NCI-2017-00998, RG1717054
- Acronym
- ADAM
- Status last verified
- Jun 2026
- First submitted
- 31 Aug 2017
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Phase 3 Trial of Adjuvant Avelumab (Anti-PDL-1 Antibody) in Merkel Cell Carcinoma Patients With Lymph Node Metastases
- ClinicalTrials.gov ID
- NCT03271372
- Acronym / sponsor ID
- ADAM / 9820
- Conditions
- Stage III Merkel Cell Carcinoma AJCC v8, Stage IIIB Merkel Cell Carcinoma AJCC v8, Stage IIIA Merkel Cell Carcinoma AJCC v8
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- EMD Serono
- Study start
- 19 Dec 2017 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 18 Feb 2029 (estimated)
- First posted
- 5 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (avelumab) | Experimental | Drug: Avelumab, Other: Peripheral Blood CollectionPatients 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. |
| Arm II (placebo) | Placebo comparator | Other: Peripheral Blood Collection, Other: PlaceboPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Histologically confirmed MCC metastases in regional lymph node(s)
- 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
- Aged >= 18 years. Both men and women, and members of all races and ethnic groups are eligible for this trial.
- Estimated life expectancy 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)
Key exclusion criteria (17 listed)
- Clinical or radiologic suspicion of residual MCC at the time of enrollment
- Suspicion or known history of distant metastatic MCC, which is not classifiable as local recurrence or regional metastasis
- Any prior systemic therapy (e.g. adjuvant, neo-adjuvant or concurrent use of chemotherapy, immunotherapy or an investigational 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]-Common Terminology Criteria for Adverse Events [NCI-CTCAE v 5.0]) that could interfere with study endpoints or put patient safety at risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvelumabAlso: Bavencio, MSB-0010718C, MSB0010718CGiven IV | Drug | Arm I (avelumab) |
| Peripheral Blood CollectionCorrelative studies | Other | Arm I (avelumab), Arm II (placebo) |
| PlaceboAlso: placebo therapy, PLCB, normal saline solutionGiven IV | Other | Arm II (placebo) |
Primary outcome
Relapse-free survival
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
The Kaplan-Meier technique will be used to obtain estimates.
4 secondary outcomes
Overall survival
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
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
Distant-metastases free survival
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
Incidence of adverse events
Time frame: Throughout the duration of the treatment (up to 2 years after randomization)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shailender Bhatia principal investigator
Fred Hutch/University of Washington Cancer Consortium
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Avelumab and Peripheral Blood Collection in people with Stage III Merkel Cell Carcinoma AJCC v8 and Stage IIIB Merkel Cell Carcinoma AJCC v8, run by University of Washington at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-free survival (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.