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
Overview
- Phase
- Phase 2
- Intervention
- Ipilimumab
- Conditions
- Melanoma
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 31
- Locations
- 8
- Primary Endpoint
- Overall Survival
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
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
Arms & Interventions
Ipilimumab, 3 mg/kg
Participants received ipilimumab, 3 mg/kg, by intravenous infusion, every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
Intervention: Ipilimumab
Chemotherapy
Participants received the investigator's choice of chemotherapy, administered per package instructions.
Intervention: Chemotherapy
Outcomes
Primary Outcomes
Overall Survival
Time Frame: From randomization to death or last known alive date, assessed up to 15.6 months
Overall survival is defined for each patient as the time between randomization and death. If a patient has not died, he or she will be censored at the time of last contact (last known alive date)
Secondary Outcomes
- Disease Control Rate (DCR)(Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease)
- Best Overall Response Rate (BORR)(Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease)