A Phase Ib/3, Multicenter, Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresectable Stage IIIB to IVM1c Melanoma (MASTERKEY-265)

Protocol: 
AAAQ6504
Phase: 
I/II

A Phase Ib/3, Multicenter, Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresectable Stage IIIB to IVM1c Melanoma (MASTERKEY-265)

The purpose of this study is to find out more about the Amgen agent called talimogene laherparepvec in people with advanced melanoma when given in combination with another drug developed by Merck called pembrolizumab. 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 2 parts; Phase 1b and Phase 3. • Phase 1b of the study will see if talimogene laherparepvec in combination with pembrolizumab is safe for people with advanced melanoma to take. Enrollment in this phase of the study is complete. • Phase 3 of the study will see if talimogene laherparepvec in combination with pembrolizumab is effective compared to placebo with pembrolizumab in people with advanced melanoma after their cancer has worsened. Placebo will contain the ingredients of the solution of talimogene laherparepvec but without the virus.

Are you Eligible? (Inclusion Criteria)

1. Male or female age >= 18 years at the time of informed consent
2. Histologically confirmed diagnosis of melanoma
3. Disease stage: Subject with unresectable stage IIIB, IIIC, IVM1a, IVM1b, or
IVM1c melanoma

Specialty Area(s)

Immunotherapy

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States