|Closed||Malignant Melanoma||Phase II||NCT01704287|
This study is being done to compare survival using MK-3475 or standard chemotherapy for participants with advanced melanoma (MEL) who have progressed after prior therapy. Participants will be randomized to receive either low dose MK-3475, higher dose MK-3475, or Investigator-choice chemotherapy. The MK-3475 dose will be blinded to Investigators and participants. The randomization to either MK-3475 or Investigator choice chemotherapy will be conducted in open-label fashion. The five standard chemotherapy choices are carboplatin + paclitaxel, carboplatin alone, paclitaxel alone, dacarbazine, or temozolomide.
- Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic MEL not amenable to local therapy
- Participants must have progressive disease after the most recent treatment regimen
- Must consent to allow correlative studies and should have available tumor tissue
- Radiographically measurable disease
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Chemotherapy, radiation therapy, or biological therapy within four weeks prior to the first dose of study drug, or not recovered from the AEs due to cancer therapies administered more than four weeks earlier
- Participating or has participated in a study of an investigational agent or using an investigational device within 30 days of the first dose of study drug
- Expected to require any other form of systemic or localized antineoplastic therapy while on study
- Chronic systemic steroid therapy within two weeks before the planned date for first dose randomized treatment or on any other form of immunosuppressive medication
- Known history of any other than the current malignancy excepting adequately treated basal or squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, breast cancer, or other in situ cancers
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
- Prior treatment with any other anti-programmed cell death (PD) agent
- Active infection requiring systemic therapy
- Known history of Human Immunodeficiency Virus (HIV)
- Active Hepatitis B or Hepatitis C
- Regular user (including recreational use of) illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol)
- Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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