<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03271372</url>
  </required_header>
  <id_info>
    <org_study_id>9820</org_study_id>
    <secondary_id>NCI-2017-00998</secondary_id>
    <secondary_id>RG1717054</secondary_id>
    <nct_id>NCT03271372</nct_id>
  </id_info>
  <brief_title>Adjuvant Avelumab in Merkel Cell Cancer</brief_title>
  <acronym>ADAM</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>EMD Serono</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized phase III trial studies how well avelumab works in treating patients with&#xD;
      Merkel cell cancer that has spread to the lymph nodes and have undergone surgery and/or&#xD;
      radiation therapy. Immunotherapy with monoclonal antibodies, such as avelumab, may help the&#xD;
      body's immune system attack the cancer, and may interfere with the ability of tumor cells to&#xD;
      grow and spread.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OUTLINE:&#xD;
&#xD;
      Patients are randomized to 1 of 2 arms.&#xD;
&#xD;
      ARM I: Patients receive avelumab intravenously (IV) over 1 hour once every 15 days for the&#xD;
      first 120 days (Induction Phase 1), once every 30 days for the next 120 days (Induction Phase&#xD;
      2), and then once every 120 days (Maintenance Phase) for a maximum of 720 days (approximately&#xD;
      24 months or 2 years total) in the absence of disease progression or unacceptable toxicity.&#xD;
&#xD;
      ARM II: Patients receive placebo IV over 1 hour once every 15 days for the first 120 days&#xD;
      (Induction Phase 1), once every 30 days for the next 120 days (Induction Phase 2), and then&#xD;
      once every 120 days (Maintenance Phase) for a maximum of 720 days (approximately 24 months or&#xD;
      2 years total) in the absence of disease progression or unacceptable toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up every 6 months for 5 years from&#xD;
      day 1 and then once every 12 months until the study is terminated by the sponsor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 19, 2017</start_date>
  <completion_date type="Anticipated">July 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2025</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Relapse-free survival</measure>
    <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</time_frame>
    <description>The Kaplan-Meier technique will be used to obtain estimates.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <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</time_frame>
    <description>The Kaplan-Meier technique will be used to obtain estimates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-specific survival</measure>
    <time_frame>From the date of randomization and the date of death from Merkel cell carcinoma, assessed for up to 5 years</time_frame>
    <description>Cumulative incidence estimates will be used to summarize the probabilities of disease-specific survival.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant-metastases free survival</measure>
    <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</time_frame>
    <description>The Kaplan-Meier technique will be used to obtain estimates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Throughout the duration of the treatment (up to 2 years after randomization)</time_frame>
    <description>Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>AMERK serology</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Blood test to predict recurrence in those patients who had a positive titer at baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Biomarker exploration in tumor and peripheral blood samples</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Tumor and peripheral blood samples.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Stage III Merkel Cell Carcinoma AJCC v8</condition>
  <condition>Stage IIIB Merkel Cell Carcinoma AJCC v8</condition>
  <condition>Stage IIIA Merkel Cell Carcinoma AJCC v8</condition>
  <arm_group>
    <arm_group_label>Arm I (avelumab)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (placebo)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Avelumab</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Arm I (avelumab)</arm_group_label>
    <other_name>Bavencio</other_name>
    <other_name>MSB-0010718C</other_name>
    <other_name>MSB0010718C</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Peripheral Blood Collection</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Arm I (avelumab)</arm_group_label>
    <arm_group_label>Arm II (placebo)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Arm II (placebo)</arm_group_label>
    <other_name>placebo therapy</other_name>
    <other_name>PLCB</other_name>
    <other_name>normal saline solution</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed MCC metastases in regional lymph node(s)&#xD;
&#xD;
               -  Confirmation of the MCC diagnosis in the regional lymph node(s) is mandatory for&#xD;
                  trial participation&#xD;
&#xD;
               -  (NOTE: In-transit metastases without regional nodal involvement could be allowed,&#xD;
                  but only after written approval of the medical monitor)&#xD;
&#xD;
          -  Must have completed definitive treatment for primary MCC and regional lymphatic&#xD;
             metastases that included surgical removal (with/without adjuvant radiation therapy) or&#xD;
             primary radiation therapy as determined by the treating investigator&#xD;
&#xD;
          -  Aged &gt;= 18 years. Both men and women, and members of all races and ethnic groups are&#xD;
             eligible for this trial.&#xD;
&#xD;
          -  Estimated life expectancy greater than 3 years&#xD;
&#xD;
          -  Must start the study treatment no more than 120 days from the start date of definitive&#xD;
             therapy (the date of surgical removal of nodal metastases or the date of initiation of&#xD;
             definitive radiation therapy, as applicable)&#xD;
&#xD;
          -  Eastern Co-Operative Group (Eastern Cooperative Oncology Group [ECOG]) performance&#xD;
             score of 0 or 1&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L&#xD;
&#xD;
          -  Platelet count ≥ 100 x 10^9/L&#xD;
&#xD;
          -  Hemoglobin ≥ 9 g/dL (may have been transfused)&#xD;
&#xD;
          -  Total bilirubin level ≤ 1.5 x the upper limit of normal (ULN) range&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 x ULN&#xD;
&#xD;
          -  Estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula or&#xD;
             by 24-hour urine collection for creatinine clearance or according to local&#xD;
             institutional standard&#xD;
&#xD;
          -  Women of childbearing potential must have a negative serum or urine pregnancy test at&#xD;
             screening&#xD;
&#xD;
          -  Both male and female subjects must be willing to use highly effective contraception&#xD;
             (that is, methods with a failure rate of less than 1% per year) throughout the study&#xD;
             and for at least 30 days after last avelumab treatment administration if the risk of&#xD;
             conception exists&#xD;
&#xD;
             * (NOTE: The effects of the study treatment on the developing human fetus are unknown;&#xD;
             thus, women of childbearing potential and men must agree to use highly effective&#xD;
             contraception, as stipulated in national or local guidelines. Should a woman become&#xD;
             pregnant or suspect she is pregnant while she or her partner is participating in this&#xD;
             study, the treating physician should be informed immediately.)&#xD;
&#xD;
          -  Must have an ability to understand and the willingness to sign a written informed&#xD;
             consent document&#xD;
&#xD;
          -  Must consent to allow the acquisition of existing formalin-fixed paraffin-embedded&#xD;
             (FFPE) tumor tissue, either a block or unstained slides, for performance of&#xD;
             correlative studies&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical or radiologic suspicion of residual MCC at the time of enrollment&#xD;
&#xD;
          -  Suspicion or known history of distant metastatic MCC, which is not classifiable as&#xD;
             local recurrence or regional metastasis&#xD;
&#xD;
          -  Any prior systemic therapy (e.g. adjuvant, neo-adjuvant or concurrent use of&#xD;
             chemotherapy, immunotherapy or an investigational agent) for MCC at any time&#xD;
&#xD;
          -  Any prior intra-lesional MCC therapy within 180 days from day 1 of study treatment&#xD;
&#xD;
          -  Residual toxicity from prior therapy grade &gt; 1 (National Cancer Institute [NCI]-Common&#xD;
             Terminology Criteria for Adverse Events [NCI-CTCAE v 5.0]) that could interfere with&#xD;
             study endpoints or put patient safety at risk&#xD;
&#xD;
          -  Previous malignant disease (other than Merkel cell carcinoma) diagnosed within 3 years&#xD;
             from day 1 of study treatment that could interfere with study endpoints or put patient&#xD;
             safety at risk&#xD;
&#xD;
             * (NOTE: Exception will be made for adequately treated basal or squamous cell&#xD;
             carcinoma of the skin or carcinoma in situ [skin, bladder, cervical, colorectal,&#xD;
             breast] or low grade prostatic intraepithelial neoplasia or Grade 1 prostate cancer;&#xD;
             any other neoplasm, which is adjudged by the treating investigator to have a low risk&#xD;
             of recurrence during the study, could be enrolled only after written approval from the&#xD;
             medical monitor)&#xD;
&#xD;
          -  Use of any systemic immunosuppressive treatments including corticosteroids,&#xD;
             cyclosporine, mycophenolate mofetil et cetera, ongoing or within the last 3 months&#xD;
             prior to day 1 of treatment&#xD;
&#xD;
             * (NOTE: Patients on physiologic dose of corticosteroids [≤ 10 mg/day of prednisone or&#xD;
             equivalent] for long-term hormone-replacement therapy or those requiring short,&#xD;
             intermittent courses of corticosteroids for hypersensitivity prophylaxis [such as for&#xD;
             iodinated computed tomography (CT) contrast prophylaxis] or those using intranasal,&#xD;
             inhaled, topical steroids, or local steroid injection [e.g., intra-articular&#xD;
             injection] can be allowed)&#xD;
&#xD;
          -  Immunosuppressed status due to known human immunodeficiency virus (HIV) infection,&#xD;
             severe uncontrolled diabetes, concurrent hematological malignancy, or other&#xD;
             comorbidities&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, active serious&#xD;
             infection, active hepatitis B or hepatitis C infection, uncontrolled seizure disorder,&#xD;
             substance abuse disorder, or psychiatric illness/social situations that would limit&#xD;
             compliance with study requirements or would put the patient at increased risk of&#xD;
             complications during the study period&#xD;
&#xD;
          -  Clinically significant (i.e., active) cardiovascular disease: cerebral vascular&#xD;
             accident/stroke (&lt; 6 months prior to enrollment), myocardial infarction (&lt; 6 months&#xD;
             prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart&#xD;
             Association Classification Class II), or serious cardiac arrhythmia requiring&#xD;
             medication&#xD;
&#xD;
          -  Active or history of any serious autoimmune disease, prior organ transplantation,&#xD;
             including allogeneic stem-cell transplantation or immune-deficiencies that required&#xD;
             treatment with systemic immunosuppressive drugs and could flare-up during study&#xD;
             treatment&#xD;
&#xD;
             * (NOTE: Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid&#xD;
             diseases not requiring immunosuppressive treatment are eligible)&#xD;
&#xD;
          -  Other severe acute or chronic medical conditions including immune-mediated colitis,&#xD;
             inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions&#xD;
             including recent (within the past year) or active suicidal ideation or behavior; or&#xD;
             laboratory abnormalities that may increase the risk associated with study&#xD;
             participation or study treatment administration or may interfere with the&#xD;
             interpretation of study results and, in the judgment of the investigator, would make&#xD;
             the patient inappropriate for entry into this study&#xD;
&#xD;
          -  Known prior severe hypersensitivity to investigational product or any component in its&#xD;
             formulations that could interfere with study endpoints or put patient safety at risk&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shailender Bhatia</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fred Hutch/University of Washington Cancer Consortium</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>ADAM Trial Coordinator</last_name>
    <phone>206-606-1795</phone>
    <email>adamtrial@seattlecca.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of California Irvine Chao Family Comprehensive Cancer Center</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ling Gao</last_name>
      <phone>714-509-2450</phone>
      <email>lingg3@hs.uci.edu</email>
    </contact>
    <investigator>
      <last_name>Ling Gao</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Colorado Cancer Center University of Colorado Anschutz Medical Campus</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sarah Dickens</last_name>
      <phone>720-848-0435</phone>
      <email>sarah.dickens@cuanschutz.edu</email>
    </contact>
    <investigator>
      <last_name>Theresa Medina</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Moffitt Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Natalie Burgess</last_name>
      <email>Natalie.Burgess@Moffitt.org</email>
    </contact>
    <investigator>
      <last_name>Andrew Brohl</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sunandana Chandra</last_name>
      <phone>312-695-1300</phone>
      <email>cancertrials@northwestern.edu</email>
    </contact>
    <investigator>
      <last_name>Sunandana Chandra</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ann Silk</last_name>
      <phone>617-632-6571</phone>
      <email>Ann_Silk@DFCI.HARVARD.EDU</email>
    </contact>
    <investigator>
      <last_name>Ann Silk</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Michigan Comprehensive Cancer Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emily Norris</last_name>
      <email>ejnorris@med.umich.edu</email>
    </contact>
    <investigator>
      <last_name>Leslie Fecher</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Roswell Park Comprehensive Cancer Center</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ciara Kelly</last_name>
      <phone>646-888-4312</phone>
      <email>kellyc1@mskcc.org</email>
    </contact>
    <investigator>
      <last_name>Ciara Kelly</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of North Carolina Lineberger Comprehensive Cancer Center</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stergios Moschos</last_name>
      <phone>919-843-7713</phone>
      <email>stergios_moschos@med.unc.edu</email>
    </contact>
    <investigator>
      <last_name>Stergios Moschos</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fred Hutch/University of Washington Cancer Consortium</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ADAM Trial Coordinator</last_name>
      <phone>206-606-1795</phone>
      <email>adamtrial@seattlecca.org</email>
    </contact>
    <investigator>
      <last_name>Shailender Bhatia</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Seattle Cancer Care Alliance</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ADAM Trial Coordinator</last_name>
      <phone>206-606-1795</phone>
      <email>adamtrial@seattlecca.org</email>
    </contact>
    <investigator>
      <last_name>Shailender Bhatia</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>September 8, 2023</last_update_submitted>
  <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Merkel Cell</mesh_term>
    <mesh_term>Carcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Avelumab</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03271372
org study id: 9820
secondary id: NCI-2017-00998
secondary id: RG1717054
nct id: NCT03271372
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
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
description: The Kaplan-Meier technique will be used to obtain estimates.
measure: 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
description: The Kaplan-Meier technique will be used to obtain estimates.
measure: 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
description: Cumulative incidence estimates will be used to summarize the probabilities of disease-specific survival.
measure: 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
description: The Kaplan-Meier technique will be used to obtain estimates.
measure: Incidence of adverse events
time frame: Throughout the duration of the treatment (up to 2 years after randomization)
description: Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.
measure: AMERK serology
time frame: Up to 5 years
description: Blood test to predict recurrence in those patients who had a positive titer at baseline.
measure: Biomarker exploration in tumor and peripheral blood samples
time frame: Up to 5 years
description: Tumor and peripheral blood samples.
arm group label: Arm I (avelumab)
arm group type: Experimental
description: 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.
arm group label: Arm II (placebo)
arm group type: Placebo Comparator
description: 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.
intervention type: Drug
intervention name: Avelumab
description: Given IV
arm group label: Arm I (avelumab)
other name: Bavencio
other name: MSB-0010718C
other name: MSB0010718C
intervention type: Other
intervention name: Peripheral Blood Collection
description: Correlative studies
arm group label: Arm I (avelumab)
arm group label: Arm II (placebo)
intervention type: Other
intervention name: Placebo
description: Given IV
arm group label: Arm II (placebo)
other name: placebo therapy
other name: PLCB
other name: normal saline solution
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shailender Bhatia
role: Principal Investigator
affiliation: Fred Hutch/University of Washington Cancer Consortium
last name: ADAM Trial Coordinator
phone: 206-606-1795
email: adamtrial@seattlecca.org
facility: 
status: Recruiting
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status: Withdrawn
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status: Recruiting
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status: Recruiting
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country: United States
responsible party type: Sponsor
mesh term: Carcinoma, Merkel Cell
mesh term: Carcinoma
mesh term: Avelumab
mesh term: Antibodies, Monoclonal
sharing ipd: No