Adjuvant Therapy with Pembrolizumab versus Placebo in Resected Highrisk Stage II Melanoma: A Randomized Double-blind Phase 3 Study (KEYNOTE 716)
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Melanoma
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Age: Between 18 - 100 Years
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Gender: Male or Female
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Other Inclusion Criteria:
1) Participants must not have been previously treated for melanoma beyond complete surgical resection of the current primary melanoma lesion. 2) No more than 12 weeks may elapse between full surgical resection and first study treatment. Treatment should start only after complete wound healing from the surgery. 3) Have no evidence of metastatic disease on imaging as determined by investigator assessment. All suspicious lesions amenable to biopsy should be confirmed negative for malignancy.
You may not be eligible for this study if the following are true:
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1) Has a known additional malignancy that is progressing or has required active antineoplastic therapy (including hormonal) or surgery treatment within the past 5 years. 2) Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug. 3) Has received prior systemic anti-cancer therapy for melanoma including investigational agents.
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