Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
With
European Organisation for Research and Treatment of Cancer - EORTC
As of Amendment 8, enrollment in Part 2 has closed, and an optional pembrolizumab extension study will not be available to participants after study closure.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Completely resected Stage III melanoma
Tumor tissue available for evaluation of PD-L1 expression
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ function
No prior therapy for melanoma except surgery for primary melanoma lesions (or previously treated with interferon for thick primary melanomas without evidence of lymph node involvement are eligible)
Female participants of childbearing potential should be willing to use adequate methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication
Male participants should agree to use an adequate method of birth control starting with the first dose of study therapy through 120 days after the last dose of study medication
You may not be if
Mucosal or ocular melanoma
History of (non-infectious) pneumonitis that required steroids or current pneumonitis
History of or current interstitial lung disease
History of hematologic or primary solid tumor malignancy, unless no evidence of that disease for 5 years
Active autoimmune disease that has required systemic treatment in past 2 years
Active infection requiring therapy
Unstable hyperthyroidism or hypothyroidism
Diagnosis of immunodeficiency
Systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
Known history of human immunodeficiency virus (HIV), active Hepatitis B or C
Prior treatment with any anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4) monoclonal antibody or anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent, or prior participation in any Merck pembrolizumab clinical trial
Currently participating and receiving study therapy, or participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks of the first dose of study medication
Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of study medication
Participant is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or Sponsor staff directly involved with this trial without prospective Institutional Review Board approval (by chair or designee) is given
Clareo Health | Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/1325-MG/KEYNOTE-054)
