drugset / Trial / NCT02562755

Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone

NCT02562755 ↗

Phase 3 Completed 459 enrolled SillaJen, Inc.
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

EvaluationDrugModalityDoseRoute
Subject JX-594 Other / unclassified 1e+09 unknown Intramuscular
Subject Sorafenib Small molecule 400 mg —