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Clinical Trial Detail

Adjuvant Avelumab in Merkel Cell Cancer (ADAM)

Complete title: A Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Phase 3 Trial of Adjuvant Avelumab (anti-PDL-1 antibody) in Merkel Cell Carcinoma Patients with Clinically Detected Lymph Node Metastases

Research Study Number 9820
Principal Investigator Shailender Bhatia, MD
Phase III

Research Study Description

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 with or without radiation therapy. Monoclonal antibodies, such as avelumab, may stimulate the immune system and interfere with the ability of tumor cells to grow and spread.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older (Adult, Senior)

Sexes Eligible for Study: All

- Histologically confirmed MCC metastases in clinically detected lymph node(s)

-- * Confirmation of the MCC diagnosis in the clinically suspicious lymph node(s) is mandatory for trial participation

-- * Subjects must have had clinically-detected (i.e. either palpable or radiologically abnormal) lymph nodal metastasis

-- * (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 that included surgical removal of the clinically detected MCC metastases (with/without adjuvant radiation therapy as determined by the treating investigator)

- Estimated life expectancy greater than 3 years

- Must start the study treatment no more than 60 days from the last dose of RT (if administered) and no more than 120 days from the date of surgical removal of nodal metastases

- 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: 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

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- 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

-- * (NOTE: Patients presenting with nodal metastases in one lymph node basin and no known primary tumor are allowed to enroll)

- 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 [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

-- * (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, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 grade >= 3) that could interfere with study endpoints or put patient safety at risk

- Pregnant or breast-feeding women

Other exclusion criteria may apply.

Research Study Number 9820
Contact Seattle Cancer Care Alliance Intake Office
Telephone 800-804-8824 / 206-606-1024

Keywords: Solid Tumors; Neoplasms, Germ Cell and Embryonal; Neuroendocrine Tumor; Virus Diseases; Neuroectodermal Tumors; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Adenocarcinoma; Carcinoma; Carcinoma, Merkel Cell; Carcinoma, Neuroendocrine; Polyomavirus Infections; DNA Virus Infections; Tumor Virus Infections

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