A Phase Ib/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, Unresected, Stage IIIB-IV Melanoma
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. Subjects will be in this study for about 42 months. There will be a screening period of about 4 weeks to determine if subjects are eligible to participate in the study. If a subject is eligible to participate in the study, they will enter a treatment period. The duration of the treatment will depend on which part of the study they will participate in, how their disease responds to study drugs, or how their body tolerates the study drugs. The study doctor or his /her study staff will inform subjects which part of the study they will be participating in.
Are you Eligible? (Inclusion Criteria)
Histologically confirmed diagnosis of malignant melanoma.
Stage IIIB, IIIC, IVM1a, IVM1b, or IVM1c disease that is not suitable for surgical resection.
Phase Ib-Treatment naïve: Must not have received any prior systemic anticancer treatment consisting of chemotherapy, immunotherapy, or targeted therapy for unresected stage IIIB to IV melanoma.
Phase 2-Either treatment naïve or received only one line of systemic anticancer therapy if BRAF wild-type or up to two lines of systemic anticancer therapy including one BRAF inhibitor-containing regimen if BRAF mutant.