A Phase 2a Study of Modified Vaccinia Virus to Treat Sorafenib-naïve Advanced Liver Cancer

NCT01636284 | Completed Phase 2 Results DMC

• 1 other identifier: JX594-IV-HEP021
• Study Type: interventional
• Target: 16
• Locations: 3 countries
• Sites: 5

Brief Summary

This study is to determine how effectively JX-594 (Pexa-Vec) will prolong life in patients with advanced Hepatocellular Carcinoma (HCC) who have not been previously treated with sorafenib, and the safe administration of JX-594 in five weekly IV infusions.

Conditions

Hepatocellular Carinoma

Keywords

Liver Cancer; HCC; first line HCC; Pexa-Vec; JX-594

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Radiographic Response

  Number of Participants with Complete response \[CR\] or partial response \[PR\] per modified Response Evaluation Criteria in Solid Tumors (mRECIST) for target and non-target lesions assessed by enhanced CT scan: CR, disappearance of intratumoral enhancing area; PR, \>=30% decrease in sum of diameters of enhancing area; Radiographic Response = CR + PR

  CT scans every 6 week from Week 6 up to 12 months

Secondary Outcomes (2)

• Time to Progression (TTP)

  CT scans every 6 week from Week 6 up to 12 months.

• Overall Survival (OS)

  CT scans every 6 week from Week 6 up to 12 months

Study Arms (1)

JX-594 recombinant vaccina GM-CSF

EXPERIMENTAL

JX-594 recombinant vaccina GM-CSF

Biological: JX-594 recombinant vaccina GM-CSF

Interventions

JX-594 recombinant vaccina GM-CSF BIOLOGICAL

Enrolled patients will receive 5 weekly IV infusions on Days 1, 8, 15, 22, and 29. After Day 43, if their disease has improved or remained stable and they have not started other cancer therapy, they may be able to continue to receive JX-594 via IV infusion every three weeks. This treatment extension may continue until radiologic progressive disease, initiation of other cancer therapy, or patient withdrawal.

JX-594 recombinant vaccina GM-CSF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic or cytologic confirmation of advanced primary hepatocellular carcinoma (HCC)
• Measurable tumor (at least one tumor with ≥1 cm LD of contrast-enhancement during the arterial phase on CT scanning)
• ECOG performance status 0, 1 or 2
• Child-Pugh Class A; or Child-Pugh Class B7 without clinically significant ascites
• Platelet count ≥50,000 plts/mm3
• WBC count ≥2,000 cells/mm3 and ≤50,000 cells/mm3
• Hemoglobin ≥10 g/dL
• Adequate liver function

You may not qualify if:

• Received sorafenib as previous treatment for HCC for more than 14 days
• History of severe exfoliative skin condition (e.g., eczema or atopic dermatitis requiring systemic therapy for \> 4 weeks)
• Prior treatment with JX-594
• Known significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication
• Severe or unstable cardiac disease
• Viable CNS malignancy associated with clinical symptoms
• Pregnant or nursing an infant
• Significant bleeding event within the last 12 months.

Sponsors & Collaborators

• Jennerex Biotherapeutics: lead

Study Sites (5)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Pusan National University Hospital

Pusan, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, South Korea

Location

University Clinic of Navarra

Pamplona, Navarre, Spain

Location

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Kyoung Soo Ha, Head of Clinical Development
• Organization: Sillajen Biotherapeutics Inc.

ksha@kr.sillajen.com

+1-415-281-8886

Study Officials

• James Burke, MD

  Jennerex Biotherapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2012
• First Posted: July 10, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 20, 2021
• Results First Posted: November 24, 2020

Record last verified: 2020-12

Locations

US (2); KR (2); ES (1)