Neoplasms

All Conditions

Digestive System Diseases

Infections

Symptoms and General Pathology

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Virus Diseases

Vaccinia

Communicable Diseases

Poxviridae Infections

DNA Virus Infections

Hematinics

All Drugs and Chemicals

Antineoplastic Agents

Liver Extracts

Sorafenib

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

James Burke, MD

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.

This was a Phase 2a, two-staged, single-arm, open-label study in sorafenib-naïve patients with advanced HCC.

Patients received 5 weekly IV infusions of Pexa-Vec and could have continued to receive IV infusions of Pexa-Vec every 3 weeks until progressive disease (PD).

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

A Single-Arm, Open-Label Phase 2 Study of JX 594 (Thymidine Kinase-Deactivated Vaccinia Virus Plus GM-CSF) Administered by Weekly Intravenous (IV) Infusions in Sorafenib-naïve Patients With Advanced Hepatocellular Carcinoma (HCC)

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

TTP (in months) was defined as the number of months from the date of first Pexa-Vec infusion to the date of disease progression. If the patient had no progression then TTP was censored at the date of last evaluable tumor assessment. TTP was summarized and a Kaplan Meier (KM) curve was constructed.

OS was defined as the time from first dose of Pexa-Vec until death from any cause. For patients not known to have died at the time of the analysis, OS was censored on the date they were last known to be alive. OS was summarized and a KM curve was constructed.

Jennerex Biotherapeutics

JX-594 recombinant vaccina GM-CSF

JX-594 recombinant vaccina GM-CSF: 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

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

South Korea

United States

Region of Enrollment

Kyoung Soo Ha, Head of Clinical Development

Number of Participants With Radiographic Response

Time to Progression (TTP)

Overall Survival (OS)

Overall Study

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Nivolumab

Bevacizumab

Relatlimab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Immune Checkpoint Inhibitors

Placebo

BMS Study Connect Contact Center www.BMSStudyConnect.com

First line of the email MUST contain NCT # and Site #.

Anthony El-Khoueiry, Site 0042

Richard Finn, Site 0039

Ari Baron, Site 0034

Aiwu He, Site 0030

Mark Yarchoan, Site 0059

Elizabeth Walsh, Site 0060

Mary Linton Peters, Site 0065

Yvonne Saenger, Site 0062

James Harding, Site 0061

Aditya Shreenivas, Site 0033

Site 0045

Site 0022

Niall Tebbutt, Site 0026

Jacinta Holmes, Site 0013

Site 0017

Site 0025

Eric Chen, Site 0009

Yabing Guo, Site 0064

Guohong Han, Site 0066

Site 0021

Site 0011

Site 0012

Albert Tran, Site 0001

Site 0002

Julien Edeline, Site 0008

Site 0054

Christoph Roderburg, Site 0051

Joerg Trojan, Site 0035

Peter Galle, Site 0057

Site 0055

Thomas Yau, Site 0004

Site 0031

Site 0036

Francesca Bergamo, Site 0003

Site 0010

Site 0047

Fujimasa Tada, Site 0048

Tatsuya Yamashita, Site 0058

Kazushi Numata, Site 0050

Site 0041

Site 0063

Site 0037

Min-Hee Ryu, Site 0056

Bogdan Zurawski, Site 0028

Lucjan Wyrwicz, Site 0016

Site 0023

Marcia Cruz-Correa, Site 0052

Mirelis Acosta Rivera, Site 0019

David Wai Meng Tai, Site 0029

Site 0027

Chong Ming Yeo, Site 0018

Site 0044

Francisca Vazquez, Site 0032

Site 0007

Bruno Sangro, Site 0067

Jaime Feliu, Site 0053

Bruno Sangro, Site 0038

Roberto Pazo Cid, Site 0040

Site 0043

Teng-Yu Lee, Site 0024

Ann-Lii Cheng, Site 0046

Site 0049

Bristol-Myers Squibb

The purpose of this study is to evaluate the safety and effectiveness of triplet therapy of nivolumab, relatlimab and bevacizumab versus nivolumab and bevacizumab in participants with untreated advanced/metastatic hepatocellular carcinoma (HCC).

A Study of Nivolumab and Relatlimab in Combination With Bevacizumab in Advanced Liver Cancer

A Phase 1/2, Safety Confirmation, Placebo-controlled, Randomized Study of Nivolumab in Combination With Relatlimab and Bevacizumab in Treatment-naive Advanced/Metastatic Hepatocellular Carcinoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Phase 2a Study of Modified Vaccinia Virus to Treat Sorafenib-naïve Advanced Liver Cancer	NCT01636284	Hepatocellular ...	JX-594 recombin...	18 Years -	SillaJen, Inc.
A Study of Nivolumab and Relatlimab in Combination With Bevacizumab in Advanced Liver Cancer	NCT05337137	Carcinoma, Hepa...	Relatlimab Nivolumab Bevacizumab Placebo	18 Years -	Bristol-Myers Squibb

Spots Global Cancer Trial Database for first line hcc