Study to Compare the Effect of Ipilimumab Retreatment With That of Chemotherapy in Advanced Melanoma

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Melanoma

Intervention / Treatment
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* Biological: Ipilimumab
* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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For more information regarding BMS clinical trial participation, please visit www.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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ipilimumab, 3 mg/kg<br>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 | Biological: Ipilimumab<br> <br> * Other names: BMS-734016;|
| Active Comparator: Chemotherapy<br>Participants received the investigator's choice of chemotherapy, administered per package instructions. | Drug: Chemotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | 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) | From randomization to death or last known alive date, assessed up to 15.6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control Rate (DCR) | DCR is defined per arm as the total number of randomized participants with best overall response as complete response, partial response, or stable disease, divided by the total number of randomized participants in the arm. Bristol-Myers Squibb terminated this study early because the study would not meet its scientific objective in the predefined time frame. Thus, no participants were analyzed. Because the study ended before best overall response could be determined, no participants were analyzed. | 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) | BORR is defined per arm as the total number of randomized patients with a best overall response of complete response or partial response, divided by the total number of randomized patients in the arm. Bristol-Myers Squibb terminated this study early because the study would not meet its scientific objective in the predefined timeframe. Because the study ended before best overall response for all patients was defined, no participant data was analyzed. | Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease |