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, Unresectable, Stage IIIb-IV Melanoma

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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, Unresectable, Stage IIIb-IV Melanoma

Phase 1b: To determine the safety and tolerability of talimogene laherparepvec in combination with ipilimumab as assessed by incidence of dose-limiting toxicities (DLT) in subjects with previously untreated, unresectable, stages IIIb to IV melanoma.
Phase 2: To estimate the efficacy of talimogene laherparepvec in combination with ipilimumab versus ipilimumab alone as assessed by overall survival (OS) in subjects with previously untreated, unresectable, stages IIIb to IV melanoma.
Secondary Objective(s):
Phase 1b:
To estimate the efficacy of talimogene laherparepvec in combination with ipilimumab as
determined by objective response rate (ORR)
To assess the safety of talimogene laherparepvec in combination with ipilimumab as determined by incidence of all adverse event (AE)s, grade ? 3 AEs (AEs), serious adverse events (SAEs), and events requiring the discontinuation of study drug, local effects on the tumor (ie, pain, inflammation and ulceration), clinically significant laboratory changes, and clinically significant changes in vital signs not defined as DLT
Phase 2:
To estimate the efficacy of talimogene laherparepvec in combination with ipilimumab versus
ipilimumab alone as determined by ORR, duration of response (DOR), time to response (TTR), progression free survival (PFS), resection rate, 1-year survival rate, and 2-year survival rate
To assess the safety of talimogene laherparepvec in combination with ipilimumab versus ipilimumab alone as determined by incidence of all AEs, grade ? 3 AEs, SAEs, and events requiring the discontinuation of study drug, local effects on the tumor (ie, pain, inflammation and ulceration), clinically significant laboratory changes, and clinically significant changes in vital signs

Protocol Number091311
Principal InvestigatorHoward Kaufman
PhasePhase I/II
ScopeNational
Applicable Disease SitesMelanoma, skin
Therapies InvolvedChemotherapy single agent systemic
Chemotherapy multiple agents systemic
Drugs InvolvedIPILIMUMAB (MDX-010)
Talimogene laherparepvec
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.