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, Unresected, Stage IIIb-IV Melanoma
Study for subjects with untreated Melanoma using trial drugs Talimogene Laherparepvec and Ipilimumab
Sponsor: Amgen Inc.
Enrolling: Male and Female Patients
Study Length: 48 Months
IRB Number: AAAN0105
U.S. Govt. ID: NCT01740297
Contact: Michelle Rae: 212 342 6042 / mlr2178@columbia.edu
Additional Study Information: 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. Phase 1 of the study will be done to see if talimogene laherparepvec in combination with ipilimumab is safe for people with advanced melanoma to take. Phase 2 of this study will be done to see if talimogene laherparepvec in combination with ipilimumab improves survival and, whether the combination causes any increase in the frequency of side effects. Participants will be in this study for about 42 months which include a screening period, a treatment period, an off treatment visit and a follow-up period.
This study is closed
Bret Taback, MD
Do You Qualify?
Do you have Stage IIIb, IIIc, IVM1a, IVM1b, or IVM1 melanoma that is not suitable for surgical removal? Yes No
Do you have a history of gastrointestinal inflammatory bowel disease or other symptomatic autoimmune disease? Yes No
You may be eligible for this study

Place Holder

For more information, please contact:
Michelle Rae
212 342 6042