NCT02409524

An Individualized Anti-Cancer Vaccine in Advanced Hepatocellular Carcinoma Subjects

Phase IIA Clinical Study Of An Individualized Anti-Cancer Vaccine (CRCL-ALLOVAX) in Subjects With Advanced Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Mirror Biologics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single site, Phase IIA clinical trial to investigate the safety and efficacy of an individualized anti-cancer vaccine (CRCL-AlloVax) in advanced HCC patients.

Detailed description

Hepatocellular carcinoma (HCC) or primary liver cancer is the third leading cause of cancer death worldwide. It accounts for 90% of all liver cancers. More than 80% of patients present with advanced or unresectable disease. For patients with vascular invasion and/or metastases, the only approved therapy that offers a survival advantage is Sorafenib (Nexavar®). While palliative systemic chemotherapy other than Sorafenib is sometimes offered for HCC, there is no evidence that any chemotherapy has any meaningful therapeutic benefit, especially in overall survival. Subjects in the current study will either have completed at least 90 days of sorafenib treatment or are not able to receive sorafenib due to intolerability or unable to afford. Subjects will continue sorafenib as tolerated while receiving experimental therapy. The experimental dosing schedule has four segments: (1) priming, which consists of intradermal AlloStim alone; (2) vaccination, which consists of intradermal dosing of AlloStim+CRCL; (3) activation, which consists of an intravenous infusion of AlloStim; and (4) booster, which consists of monthly intradermal injections of CRCL alone

Conditions

• Advanced Adult Hepatocellular Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	AlloVax	Personalized anti-cancer vaccine (injection of AlloStim followed immediately by the injection of CRCL)
BIOLOGICAL	AlloStim	AlloStim (ID) injection AlloStim (IV) infusion
BIOLOGICAL	CRCL	Autologous tumor-derived chaperone protein mixture

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-06-01
• Completion: 2019-03-01
• First posted: 2015-04-07
• Last updated: 2020-01-22

Locations

1 site across 1 country: Thailand