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
ID Number 13-0094Principal Investigator(s)
Department(s) or Division(s)
Hematology and Medical Oncology
The purpose of this study is to find out more about talimogene laherparepvec (formerly known as OncoVEXGM-CSF), in people with advanced melanoma when given in combination with another drug called ipilimumab. Melanoma is a type of skin cancer. Advanced melanoma means the tumor is not removable by surgery or has spread to other parts of the body.
The 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.
Recruiting Patients: Yes