drugset / Trial / NCT03663712
Talimogene Laherparepvec for the Treatment of Peritoneal Surface Malignancies
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The primary objective of this open-label, Phase I, trial is to evaluate the toxicity profile of intraperitoneal talimogene laherparepvec (TVEC) in patients with peritoneal surface dissemination from gastrointestinal or recurrent, platinum-resistant ovarian tumors. The secondary objectives are to evaluate the pharmacokinetic profile and viral shedding of TVEC by measuring viral load in serum and urine as well as viral load in peritoneal washings.
Timeline
- Start
- 2019-05-23
- Primary completion
- 2022-10-13
- Completion
- 2022-10-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Talimogene Laherparepvec | Other / unclassified | 4e+06 unknown | Intrathecal |
| Subject | Talimogene Laherparepvec | Other / unclassified | 4e+07 unknown | Intrathecal |
| Subject | Talimogene Laherparepvec | Other / unclassified | 4e+08 unknown | Intrathecal |