An Individualized Anti-Cancer Vaccine in Advanced Hepatocellular Carcinoma Subjects

Phase 2

Completed

• Conditions: Advanced Adult Hepatocellular Carcinoma
• Interventions: Biological: AlloVax; Biological: AlloStim; Biological: CRCL

• Registration Number: NCT02409524
• Lead Sponsor: Mirror Biologics, Inc.

Brief 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

Study Timeline

• Study First Submitted: 2015-04-01
• Study First Submitted QC: 2015-04-06
• Study First Posted: 2015-04-07
• Study Start: 2016-07
• Primary Completion: 2017-06
• Status Verified: 2017-11
• Study Completion: 2019-03
• Last Update Submitted: 2020-01-17
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	CRCL	The treatment schedule of AlloVax includes: (1) Priming segment with ID injections of AlloStim on Days 0, 3, 7 and 10. (2) Vaccination segment with ID injections of AlloStim+CRCL on Days 14, 17, 21 and 24. (3) Activation segment with IV push infusion of AlloStim on Day 28. (4) Booster Segment with monthly (every 28 days) ID injections of CRCL alone beginning on Day 56. These injections will continue until all the vaccine is used or the death of the subject
Treatment	AlloVax	The treatment schedule of AlloVax includes: (1) Priming segment with ID injections of AlloStim on Days 0, 3, 7 and 10. (2) Vaccination segment with ID injections of AlloStim+CRCL on Days 14, 17, 21 and 24. (3) Activation segment with IV push infusion of AlloStim on Day 28. (4) Booster Segment with monthly (every 28 days) ID injections of CRCL alone beginning on Day 56. These injections will continue until all the vaccine is used or the death of the subject
Treatment	AlloStim	The treatment schedule of AlloVax includes: (1) Priming segment with ID injections of AlloStim on Days 0, 3, 7 and 10. (2) Vaccination segment with ID injections of AlloStim+CRCL on Days 14, 17, 21 and 24. (3) Activation segment with IV push infusion of AlloStim on Day 28. (4) Booster Segment with monthly (every 28 days) ID injections of CRCL alone beginning on Day 56. These injections will continue until all the vaccine is used or the death of the subject

Primary Outcome Measures

Name	Time	Method
To evaluate survival compared to historical controls	Approximately 12 months	Baseline to date of death from any cause

Secondary Outcome Measures

Name	Time	Method
To assess AFP as surrogate end-point for response and/or survival	Approximately 6 months	Biomarker concentration will be evaluated at different time points
To assess mRECIST as surrogate end-point for response and/or survival	Approximately 6 months	Objective tumor responses by mRECIST will be compared with OS
To evaluate safety in advanced HCC (adverse events)	Approximately 6 months	Subjects will be followed by physical exam, blood labs, CT scan and biopsy for any adverse events

Trial Locations

Locations (1)

National Cancer Institute of Thailand Address: 268/1 Rama Rd. Ratchathewi; 🇹🇭 Bangkok, Thailand