Aldesleukin and Pembrolizumab in Treating Patients With Stage III-IV Melanoma
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Melanoma
- Stage III Mucosal Melanoma of the Head and Neck
- Stage IIIA Skin Melanoma
- Stage IIIB Skin Melanoma
- Stage IIIC Skin Melanoma
- Stage IV Skin Melanoma
- Stage IVA Mucosal Melanoma of the Head and Neck
- Stage IVB Mucosal Melanoma of the Head and Neck
- Stage IVC Mucosal Melanoma of the Head and Neck
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 15 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To determine an optimal tolerated dose (OTD) of aldesleukin (interleukin [IL]-2) that is effective and tolerable in combination with pembrolizumab. II. To characterize the efficacy of the OTD of IL-2 in combination with pembrolizumab. SECONDARY OBJECTIVES: I. To characterize t...
PRIMARY OBJECTIVES: I. To determine an optimal tolerated dose (OTD) of aldesleukin (interleukin [IL]-2) that is effective and tolerable in combination with pembrolizumab. II. To characterize the efficacy of the OTD of IL-2 in combination with pembrolizumab. SECONDARY OBJECTIVES: I. To characterize the safety of IL-2 in doses ranging up to the Food and Drug Administration (FDA)- approved dose when administered in combination with pembrolizumab. II. To characterize clinical endpoints, including overall survival, progression-free survival, and complete response rate. TERTIARY OBJECTIVES: I. To characterize immune parameters in the blood and tumor microenvironment and cellular and molecular features of the tumor tissue that correlate with response to combination therapy for study as potential predictive biomarkers. OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 every 3 weeks and aldesleukin IV every 8 hours for up to 14 doses at weeks 4, 7, 16, 19, 28, and 31 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months up to 10 years.
Tracking Information
- NCT #
- NCT02748564
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Ann (Annie) Silk Rutgers Cancer Institute of New Jersey
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