A Pilot Study of Ipilumimab and Radiation in Poor Prognosis Melanoma

Phase 1

Completed

• Conditions: High Risk Melanoma
• Interventions: Drug: Ipilumimab; Radiation: Radiation

• Registration Number: NCT01996202
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-22
• Study First Submitted QC: 2013-11-22
• Study First Posted: 2013-11-27
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-03
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unresected Melanoma	Ipilumimab	Subjects with unresected melanoma.
Resected Melanoma	Radiation	Subjects with resected melanoma.
Resected Melanoma	Ipilumimab	Subjects with resected melanoma.
Unresected Melanoma	Radiation	Subjects with unresected melanoma.

Primary Outcome Measures

Name	Time	Method
Incidence of immune related adverse events associated with ipilimumab	2 years
Incidence of acute and late radiation toxicities	2 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States