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A Phase I, multicenter, open-label trial to evaluate the safety of talimogene laherparepvec (T-VEC) injected into liver tumors
  1. J Randolph Hecht1,
  2. Steven Raman1,
  3. Daniel Y Sze2,
  4. A Craig Lockhart3,
  5. Rebecca A Moss4,
  6. Kate Liu5,
  7. Jeffrey Chou5 and
  8. Tony Reid6
  1. Aff1 grid.19006.3e0000000096326718David Geffen School of Medicine at UCLA Los Angeles CA USA
  2. Aff2 grid.168010.e0000000419368956Stanford University School of Medicine Stanford CA USA
  3. Aff3 grid.4367.60000000123557002Washington University School of Medicine St. Louis MO USA
  4. Aff4 grid.430387.b0000000419368796Rutgers Cancer Institute of New Jersey New Brunswick NJ USA
  5. Aff5 grid.417886.40000000106575612Amgen Inc. Thousand Oaks CA USA
  6. Aff6 grid.266100.30000000121074242Moores Cancer CenterUniversity of California San Diego, La Jolla CA USA

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Meeting abstracts


T-VEC, an intralesionally-delivered oncolytic immunotherapy, is a herpes simplex virus-1 engineered to selectively replicate in tumors and stimulate an anti-tumor immune response through expression of GM-CSF. T-VEC has the ability to lyse various cancer cell types in vitro[1]. A Phase III study of T-VEC injected into skin, subcutaneous, or lymph node tumors versus subcutaneous GM-CSF in advanced melanoma demonstrated improved durable response rate for T-VEC, with regression of both injected and uninjected lesions[2]. To further explore if different types of cancers and locations might be treatable with T-VEC, this Phase I study evaluates whether primary and metastatic liver tumors may be safely and effectively injected with T-VEC.


Approximately 100 patients will be enrolled. Primary objective: evaluate maximum tolerated dose (MTD) of intrahepatic injection of T-VEC by patient incidence of dose-limiting toxicities (DLTs). Key secondary objectives: overall safety, efficacy, and biodistribution of T-VEC. Key eligibility criteria: breast, colorectal, gastroesophageal, kidney, lung cancer or melanoma with liver metastases (non-HCC) or hepatocellular carcinoma (HCC); measurable liver tumors suitable for injection; ECOG performance status 0-1; life expectancy ≥5 months; ≥1 prior standard systemic anticancer therapy (non-HCC); Child-Pugh A-B7; no detectable hepatitis B/C viral load; not a candidate for surgery or locoregional therapy of liver tumors with curative intent or planned systemic anticancer therapy; tumor in < 1/3 of the liver; no macroscopic intravascular invasion. The study consists of two parts. Part 1: 3+3 dose escalation of 3 sequential dose cohorts each administering T-VEC in increasing concentrations (107 or 108 PFU/mL) and volumes (up to 4 or 8 mL). MTD for HCC is determined separately from non-HCC tumor types; HCC cohorts will not proceed until safety at respective dose levels are determined in non-HCC. Six T-VEC doses injected under ultrasound or computed tomography guidance q21 (±3) days are planned, with an investigator option to continue for up to 6 additional doses. The first dose of T-VEC in all dose cohorts is given at 106 PFU/mL. Part 2: 7 expansion cohorts for each cancer type with 10 patients each administered the MTD of T-VEC determined from Part 1.


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