Overview
Study to Compare the Effect of Ipilimumab Retreatment With That of Chemotherapy in Advanced Melanoma
Status:
Terminated
Terminated
Trial end date:
2014-07-01
2014-07-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Bristol-Myers SquibbTreatments:
Antibodies, Monoclonal
Ipilimumab
Criteria
For more information regarding BMS clinical trial participation, please visitwww.BMSStudyConnect.com.
Key Inclusion 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 Exclusion Criteria:
- 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