Study of Talimogene Laherparepvec (T-VEC) in Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title: Study of Talimogene Laherparepvec Administered Endoscopically for the Treatment of Locally Advanced or Metastatic Pancreas Cancer Refractory to at Least One Chemotherapy Regimen

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to find out which doses of talimogene laherparepvec (T-Vec) can be given safely to participants with pancreatic cancer that is either too big to be taken out by surgery or has spread to other parts of the body. The study will also see if T-Vec can cause tumor shrinkage or prevent its growth.

The primary objective is to determine the rate of dose limiting toxicity at tested doses of talimogene laherparepvec administered endoscopically to pancreatic tumors, and to identify a maximum tolerated dose (MTD).

Secondary exploratory efficacy endpoints include change in longest diameter in the injected lesion(s), overall response rate (ORR) per RECIST v1.1 and modified immune-related response criteria (mirRC as defined in section 11), progression free survival (PFS) and overall survival (OS) at 6, 12, and 24 months.

Funding Source - FDA OOPD

Clinical Trial Description

Pancreatic ductal adenocarcinoma (PDA) is an area of great unmet need. PDA accounts for 90% of pancreatic tumors in 2016. The standard of care for pancreas cancer is cytotoxic chemotherapy, but this is not particularly effective with best response rates reported of 20-30% and no significant long-term 5-year survival for patients who are not surgical candidates. Talimogene laherparepvec (previously known as OncoVEXGM-CSF) is an intratumorally delivered oncolytic immunotherapy comprised of an immune-enhanced herpes simplex virus type-1 (HSV-1) that selectively replicates in solid tumors. Talimogene laherparepvec was the first oncolytic viral therapy to be approved by the Federal Drug Administration (FDA) for the treatment of cancer, specifically melanoma. There is the potential that talimogene laherparepvec could exert a systemic effect mitigating the potential of PDA to metastasize.

This is a phase 1 dose escalation study to evaluate the safety of talimogene laherparepvec in PDA. To find out which doses are safe, all participants enrolled in this study will receive up to 4 injections of T-Vec. At least two doses will be evaluated in this study, depending on how many side effects are seen at each dose. Participants will not be able to pick the dose, as this will be determined based on the study experience with participants enrolled previously. ;

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

• NCT number: NCT03086642
• Study type: Interventional
• Source: Columbia University
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 16, 2017
• Completion date: April 2026