An Individualized Anti-Cancer Vaccine Study in Patients With HCC

Status Withdrawn

Clinical Trial Summary

The purpose of this study is to determine the safety and the immunological, radiological, and pathological response of the personalized anti-cancer vaccine AlloVax(TM) in patients with refractory Hepatocellular Carcinoma (HCC) and who are not eligible for any approved HCC treatments or have failed all approved HCC treatments. AlloVax(TM) is a personalized anti-cancer vaccine combining Chaperone Rich Cell Lysate (CRCL) as a source of tumor antigen prepared from patient's tumor and AlloStim(TM) as an adjuvant. The combination of these two components provides a vaccine designed to bring out an immune response capable of finding and killing the tumor cells.

Clinical Trial Description

All accrued subjects will undergo tumor harvest procedure. The tumor samples will be processed into personalized Chaperone Rich Cell Lysate (CRCL) vaccine. This study consists of three phases: priming phase, vaccination phase, and activation phase. The priming phase involves intradermal injections of AlloStim(TM). The aim of this phase is to increase the titer of Th1 immune cells in circulation. The vaccination phase involves the intradermal injections of AlloSim(TM) immediately followed by the intradermal injections of CRCL. This phase is designed to elicit tumor-specific immunity. The activation phase involves intravenous infusion of AlloStim(TM). This phase is designed to activate memory cells and NK cells and cause them to extravasate and traffic to tumor sites. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01995227
Study type	Interventional
Source	Immunovative Therapies, Ltd.
Contact
Status	Withdrawn
Phase	Phase 1/Phase 2
Start date	December 2013
Completion date	July 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04209491` - Interest of the Intervention of a Nurse Coordinator in Complex Care Pathway
Completed	`NCT03963206` - Cabozantinib toLERANCE Study in HepatoCellular Carcinoma (CLERANCE)	Phase 4
Completed	`NCT03268499` - TACE Emulsion Versus Suspension	Phase 2
Recruiting	`NCT05263830` - Glypican-3 as a Prognostic Factor in Patients With Hepatocellular Carcinoma Treated by Immunotherapy
Recruiting	`NCT05044676` - Immune Cells as a New Biomarker of Response in Patients Treated by Immunotherapy for Advanced Hepatocellular Carcinoma
Recruiting	`NCT05095519` - Hepatocellular Carcinoma Imaging Using PSMA PET/CT	Phase 2
Recruiting	`NCT05497531` - Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers	N/A
Completed	`NCT05068193` - A Clinical Trial to Compare the Pharmacokinetics and Bioequivalence of "BR2008" With "BR2008-1" in Healthy Volunteers	Phase 1
Active, not recruiting	`NCT03781934` - A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations	Phase 1/Phase 2
Terminated	`NCT03655613` - APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC	Phase 1/Phase 2
Active, not recruiting	`NCT03170960` - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors	Phase 1/Phase 2
Active, not recruiting	`NCT04242199` - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors	Phase 1
Completed	`NCT04401800` - Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma	Phase 2
Withdrawn	`NCT05418387` - A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona	N/A
Active, not recruiting	`NCT04039607` - A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma	Phase 3
Terminated	`NCT03970616` - A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma	Phase 1/Phase 2
Recruiting	`NCT03642561` - Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE	Phase 2/Phase 3
Recruiting	`NCT06239155` - A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT04118114` - Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors	Phase 2
Completed	`NCT03222076` - Nivolumab With or Without Ipilimumab in Treating Patients With Resectable Liver Cancer	Phase 2