A Multicenter, Randomized, Double Blinded, Placebo Controlled, Phase 3 trial of Adjuvant Avelumab (anti PDL1 antibody) in Merkel Cell Carcinoma Patients with Clinically Detected Lymph Node Metastases
The primary objective of the trial is to compare the clinical activity of adjuvant avelumab to that of placebo, as determined by relapse]free survival in subjects with clinically detected nodal metastases from MCC after definitive therapy (surgery with/without adjuvant RT).
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.
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.
Eastern Co-Operative Group (Eastern Cooperative Oncology Group [ECOG]) performance score of 0 or 1
Adequate organ function
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.
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
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 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 [CTCAE] version [v] 4.0) 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. Exceptions may apply.
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.
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 (= 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
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
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