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

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

Timeline

Start

2017-11-16

Primary completion

2021-05-13

Completion

2022-12-31

Publications

• Runcie K, Bracero Y, Samouha A, Manji G, Remotti HE, Gonda TA, Saenger Y. Phase I study of intratumoral injection of talimogene laherparepvec for the treatment of advanced pancreatic cancer. Oncologist. 2025 Jan 17;30(1):oyae200. doi: 10.1093/oncolo/oyae200.

Drugs

Indications