Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 220
Summary
- Conditions
- Advanced Melanoma
- Metastatic Melanoma
- Recurrent Melanoma
- Stage III Cutaneous Melanoma AJCC v7
- Stage IIIA Cutaneous Melanoma AJCC v7
- Stage IIIB Cutaneous Melanoma AJCC v7
- Stage IIIC Cutaneous Melanoma AJCC v7
- Stage IV Cutaneous Melanoma AJCC v6 and v7
- Unresectable Melanoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To evaluate the overall survival for the combination of sargramostim (GM-CSF) plus ipilimumab and ipilimumab alone in patients with advanced melanoma. SECONDARY OBJECTIVES: I. To evaluate the progression-free survival, response rate, safety and tolerability for the combination...
PRIMARY OBJECTIVES: I. To evaluate the overall survival for the combination of sargramostim (GM-CSF) plus ipilimumab and ipilimumab alone in patients with advanced melanoma. SECONDARY OBJECTIVES: I. To evaluate the progression-free survival, response rate, safety and tolerability for the combination of GM-CSF plus ipilimumab and ipilimumab alone in patients with advanced melanoma. II. To explore the utility of immune related response criteria (irRC) prospectively in patients receiving ipilimumab. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, anti-tumor response is assessed and patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity. ARM B: Patients receive induction therapy comprising ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, anti-tumor response is assessed and patients then receive maintenance therapy of ipilimumab IV over 90 minutes on day 1. Treatment with ipilimumab repeats every 12 weeks. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and cycles repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Tracking Information
- NCT #
- NCT01134614
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Frank S Hodi ECOG-ACRIN Cancer Research Group