Clinical Trial Details

Short Title
Official Title
A Phase 1b/2, Multicenter, Open-label Trial to Evaluate the Safety and Efficacy of Talimogene Laherparepvec and Ipilimumab Compared to Ipilimumab Alone in Subjects With Previously Untreated, Unresectable, Stage IIIb-IV Melanoma (Amgen protocol #20110264)
Description

Participants in this research study have advanced melanoma. Advanced melanoma means that the tumor is not removable by surgery or has spread to other parts of the body.

The purpose of this research study is to find out more about Talimogene laherparepvec (formerly known as OncoVEXGM-CSF) when given in combination with another drug called ipilimumab.

This study will be conducted in two parts:
 Phase 1 of the study will see if talimogene laherparepvec in combination with ipilimumab is safe for people with advanced melanoma to take.
 Phase 2 of this study will see if talimogene laherparepvec in combination with ipilimumab improves survival and, whether the combination causes any increase in the frequency of side effects. To do this, talimogene laherparepvec in combination with ipilimumab will be compared to ipilimumab alone. Phase 2 will only start after review of information collected during Phase 1.

Approximately 12 people will take part in this study conducted by investigators at the University of Iowa. A total of about 158 people are expected to participate in the study overall, with 18 people in Phase 1 and about 140 people in Phase 2.

Start Date
March 12, 2013
End Date
March 12, 2023
Gender Preference
None
Age Group
18 - 99 years
Principal Investigator
Mohammed Milhem, MD
Contact Info

Melanie Frees, 319-356-1228

Department
Keywords
advanced melanoma ; Amgen #20110264 ; cancer ; ipilimumab ; IRB#201211780 ; melanoma ; milhem ; phase I/II ; phase one ; phase two ; talimogene laherparepvec ;

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