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10M-12-3 Randomized, Phase II Study of MK-3475 versus Chemotherapy in Patients with Advanced Melanoma

Description

This study is being done to compare survival using pembrolizumab (SCH 900475, MK-3475) or standard chemotherapy for participants with advanced melanoma (MEL) who have progressed after prior therapy. Participants were initially randomized to receive either low dose pembrolizumab, higher dose pembrolizumab or Investigator-choice chemotherapy (ICC). The randomization to either pembrolizumab or Investigator choice chemotherapy was conducted in an open-label fashion. The pembrolizumab dose was initially blinded to Investigators and participants until Amendment 03. With Amendment 03, all ongoing pembrolizumab participants will be treated with open-label, fixed dose pembrolizumab 200 mg every 3 weeks (Q3W), instead of weight-based dosing of pembrolizumab. The four standard chemotherapy choices were carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide. Participants on standard chemotherapy who experienced disease progression may have been eligible to crossover to treatment with pembrolizumab provided they met protocol-specified requirements for crossover. With Amendment 03, all crossover participants will be treated with open-label, fixed dose pembrolizumab 200 mg Q3W instead of weight-based dosing of pembrolizumab.

Phase

Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.

Inclusion and Exclusion Criteria

  • Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic MEL not amenable to local therapy
  • Participants must be refractory to ipilimumab
  • Participants with BRAF gene mutant melanoma must have had a prior treatment regimen that included vemurafenib, dabrafenib, or an approved BRAF gene and/or mitogen-activated protein kinase (MEK) protein inhibitor
  • Must consent to allow correlative studies; must provide a newly obtained tissue/biopsy specimen (or specimen obtained within 60 days of consenting)
  • Radiographically measurable disease
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  • Chemotherapy, radiation therapy, or biological cancer therapy within 4 weeks prior to the first dose of study drug, or not recovered from the adverse events due to cancer therapies administered more than 4 weeks earlier
  • Disease progression within 24 weeks of last dose of ipilimumab
  • 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 2 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 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 through 120 days after last dose of study drug

Sites

Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.

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