NCT01496807

Yervoy With Sylatron Unresectable Stage 3 or 4 Melanoma

A Phase Ib Study of Yervoy With Sylatron for Patients With Unresectable Stages IIIB/C/IV Melanoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see how much of the drug Yervoy can be safely tolerated when it is given to people who are also receiving a drug called Sylatron. Investigators also wish to find out whether the addition of Yervoy increases the chance that Sylatron will cause a rise in the level of antibodies in the patient's blood that recognize their own tissues, known as "autoimmune" antibodies. Investigators also want to find out how likely it is that their tumor will shrink.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Sylatron	Sylatron - Once per week for 12 weeks, given as an injection under the skin.
DRUG	Yervoy	Yervoy - Once every 3 weeks for 12 weeks (4 times total), given over a 90-minute intravenous infusion (through the vein).

Timeline

• Start date: 2012-02-17
• Primary completion: 2016-03-16
• Completion: 2016-08-29
• First posted: 2011-12-21
• Last updated: 2017-04-28
• Results posted: 2017-04-28

Locations

1 site across 1 country: United States