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A Phase 1b/3, Multicenter, Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresectable Stage IIIB to IVM1c Melanoma
Subjects will be treated with talimogene laherparepvec until all injectable tumors have disappeared, disease progression per modified Immune-Related Response Criteria (irRC), or intolerance of study treatment, up to a maximum of 24 months of study treatment. Subjects will be treated with MK-3475 (pembrolizumab) until complete response (CR) disease progression per irRC, or intolerance of study treatment, up to a maximum of 24 months of study treatment. Subjects with disease progression on MK-3475 in Phase 2 monotherapy arm may be eligible to receive talimogene laherparepvec in combination with MK-3475 up to 12 months. Subjects may be eligible for re-treatment (second course) of MK-3475 and/or talimogene laherparepvec if they have progressive disease after a complete response up to 12 months