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10M-13-1 A Randomized, Open-Label, Multicenter Phase II Study of Ipilimumab Retreatment versus Chemotherapy for Subjects with Advanced Melanoma who Progressed after Initially Achieving Disease Control with Ipilimumab Therapy

Description

The purpose of the study is to determine whether additional doses of ipilimumab have a positive effect on survival in the treatment of advanced melanoma that has progressed after successful initial treatment with ipilimumab.

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

  • Histologic diagnosis of unresectable stage III or IV metastatic melanoma
  • Prior ipilimumab induction treatment (3 mg/kg)
  • Documented disease control [Stable Disease ≥3 months or Partial Response/Complete Response] after ipilimumab induction
  • Documented progressive disease following disease control Key

  • Patients with brain metastasis are excluded, unless they are free of neurologic symptoms related to metastatic brain lesions and do not receive systemic corticosteroid therapy for the purpose of reducing intracranial inflammation in the 10 days prior to beginning retreatment with ipilimumab
  • Any intervening anticancer therapy between last dose of ipilimumab induction and ipilimumab retreatment on study
  • Patients who experienced any grade 3 immune-related adverse event (irAE) (except for endocrinopathies where clinical symptoms were controlled with appropriate hormone replacement therapy) or any grade 4 toxicity during prior treatment with ipilimumab
  • Patients with a prior irAE that has not improved to grade 1 or better at randomization

Sites

  • Nevada

    • Comprehensive Cancer Center Of Nevada, Las Vegas, Nevada, 89148
  • Colorado

    • Rocky Mountain Cancer Centers, Aurora, Colorado, 80012
  • Kansas

    • Cancer Center Of Kansas, Wichita, Kansas, 67214
  • Texas

    • Texas Oncology Sammons Cancer Center, Dallas, Texas, 75246
  • Alabama

    • Birmingham Hematology & Oncology Associates Llc, Birmingham, Alabama, 35205
  • Indiana

    • Investigative Clinical Research Of Indiana, Llc, Indianapolis, Indiana, 46260
  • France

    • Local Institution, Paris, 75010
  • Germany

    • Local Institution, Tubingen, 72076
    • Local Institution, Goettingen, 37075
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