drugset / Trial / NCT02562755
Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy.
Timeline
- Start
- 2015-10
- Primary completion
- 2020-07
- Completion
- 2020-07
Outcome
Missed primary endpoint
release “PHOCUS Phase 3 trial recommended stopping the study based on the IDMC’s assessment that the trial would be unlikely to meet its primary objective” transgene.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | JX-594 | Other / unclassified | 1e+09 unknown | Intramuscular |
| Subject | Sorafenib | Small molecule | 400 mg | — |