At a glance
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A Phase 2, Multicenter, Randomized, Open-label Trial Assessing the Efficacy and Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Resectable, Stage IIIB to IVM1a Melanoma
In Brief
A Phase 2 clinical trial evaluating Talimogene Laherparepvec and Immediate surgical resection of melanoma lesion(s) for Completely Resectable Stage IIIB, IIIC, or IVM1a Melanoma. Completed, enrolled 150 participants across 46 sites in 9 countries.
Detailed Summary
This is a phase 2, multicenter, randomized, open-label study to estimate the efficacy of talimogene laherparepvec as a neoadjuvant treatment followed by surgery compared to surgery alone in subjects with completely resectable stage IIIB, IIIC, or IVM1a melanoma.
Study Details
Timeline
Interventions
Talimogene laherparepvec will be administered by intralesional injection into the injectable cutaneous, subcutaneous, and nodal tumors initially at a dose of 10\^6 plaque forming units (PFU)/mL at day 1 of week 1 followed by a dose of 10\^8 PFU/mL at day 1 (±3 days) of week 4, 6, 8, 10 and 12 or until all injectable tumors have disappeared, or intolerance of study treatment or in the opinion of the investigator, immediate surgical resection or any other treatment for melanoma is warranted, whichever occurs first.
Surgical resection of melanoma tumor lesion(s) will be performed after randomization any time during weeks 1 to 6.