NCT01996202
Completed
Phase 1
A Pilot Study of Ipilumimab and Radiation in Poor Prognosis Melanoma
Overview
- Phase
- Phase 1
- Intervention
- Ipilumimab
- Conditions
- High Risk Melanoma
- Sponsor
- Duke University
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Incidence of immune related adverse events associated with ipilimumab
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This is a pilot study assessing the safety of the combination of ipilimumab administered concurrently with radiotherapy for patients with locally advanced or unresectable melanoma and patients at high risk for recurrence after resection.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Resected Melanoma
Subjects with resected melanoma.
Intervention: Ipilumimab
Resected Melanoma
Subjects with resected melanoma.
Intervention: Radiation
Unresected Melanoma
Subjects with unresected melanoma.
Intervention: Ipilumimab
Unresected Melanoma
Subjects with unresected melanoma.
Intervention: Radiation
Outcomes
Primary Outcomes
Incidence of immune related adverse events associated with ipilimumab
Time Frame: 2 years
Incidence of acute and late radiation toxicities
Time Frame: 2 years
Secondary Outcomes
- Overall response rate (ORR)(2 years)
- 6 month progression free survival (PFS)(6 months)
- 12 month progression free survival (PFS)(12 months)
- Overall survival(2 years)
- CD4+ and CD8+ reactivity to melanoma tumor antigens(2 years)
- Cytokines associated with anti-tumor response(2 years)
Study Sites (1)
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