SRS and Nivolumab in Treating Patients With Newly Diagnosed Melanoma Metastases in the Brain or Spine
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Malignant Neoplasm in the Brain
- Metastatic Malignant Neoplasm in the Spine
- Stage IV Skin Melanoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group 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 assess the safety profile of stereotactic radiosurgery with nivolumab in combination to treat patients with newly diagnosed melanoma brain or spinal metastases. SECONDARY OBJECTIVES: I. To estimate local control rate in brain and spine. II. To estimate systematic control ra...
PRIMARY OBJECTIVES: I. To assess the safety profile of stereotactic radiosurgery with nivolumab in combination to treat patients with newly diagnosed melanoma brain or spinal metastases. SECONDARY OBJECTIVES: I. To estimate local control rate in brain and spine. II. To estimate systematic control rate. III. To estimate progression-free survival. TERTIARY OBJECTIVES: I. To explore peripheral blood immune response during and after treatment. OUTLINE: Patients receive nivolumab intravenously (IV) over 60 minutes on day 1. Patients then undergo stereotactic radiosurgery on day 8 per standard of care. Courses with nivolumab repeats every 14 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, every 10 weeks, and then every 3 months thereafter.
Tracking Information
- NCT #
- NCT02716948
- Collaborators
- Accuray Incorporated
- Investigators
- Principal Investigator: Lawrence Kleinberg Johns Hopkins University/Sidney Kimmel Cancer Center
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