Woman and Man
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Extract
Phase 1b: To evaluate the safety, as assessed by incidence of dose limiting toxicity (DLT), of talimogene laherparepvec in combination with pembrolizumab in subjects with previously untreated, unresectable, stage IIIB to IVM1c melanoma. Phase 3: To evaluate the efficacy of talimogene laherparepvec with pembrolizumab versus placebo with pembrolizumab, as assessed by progression-free survival (PFS) (response evaluation by blinded central review using modified Response Evaluation Criteria in Solid Tumors 1.1 [RECIST]) and overall survival (OS).
Inclusion criteria
- Unresectable, Stage IIIB to IVM1c Melanoma