Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone (PHOCUS)
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| ClinicalTrials.gov Identifier: NCT02562755 |
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Recruitment Status :
Completed
First Posted : September 29, 2015
Results First Posted : December 16, 2020
Last Update Posted : December 16, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatocellular Carcinoma (HCC) | Biological: Pexastimogene Devacirepvec (Pexa Vec) Drug: Sorafenib | Phase 3 |
This is a multi-center, randomized, open-label, Phase 3 study comparing Pexa Vec followed by sorafenib versus sorafenib in patients with advanced HCC without prior systemic therapy.
A total of 459 patients were randomly assigned to 2 treatment arms- 234 patients in the Pexa-Vec followed by sorafenib treatment group and 225 patients in the sorafenib only treatment group.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 459 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3 Randomized, Open-Label Study Comparing Pexa Vec (Vaccinia GM CSF / Thymidine Kinase-Deactivated Virus) Followed by Sorafenib Versus Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC) Without Prior Systemic Therapy |
| Actual Study Start Date : | October 2015 |
| Actual Primary Completion Date : | July 2020 |
| Actual Study Completion Date : | July 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Pexa-Vec followed by Sorafenib
Pexa-Vec (pexastimogene devacirepvec) will be administered as 3 bi-weekly intratumoral (IT) injections of 1e9 pfu at day 1 and weeks 2 and 4, followed by sorafenib at Week 6.
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Biological: Pexastimogene Devacirepvec (Pexa Vec)
Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells.
Other Name: JX-594 Drug: Sorafenib Sorafenib belongs to the pharmacotherapeutic group of antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05. Sorafenib is a multi-kinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties in vitro and in vivo. Sorafenib is approved for the treatment of advanced HCC and is the Standard Of Care for this disease. Other Name: Nexavar |
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Active Comparator: Sorafenib
Sorafenib (400 mg twice daily) begins on Day 1.
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Drug: Sorafenib
Sorafenib belongs to the pharmacotherapeutic group of antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05. Sorafenib is a multi-kinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties in vitro and in vivo. Sorafenib is approved for the treatment of advanced HCC and is the Standard Of Care for this disease. Other Name: Nexavar |
- Overall Response Rate (ORR) [ Time Frame: From date of randomization to the date of first documented radiographic tumor progression up to 53 months ]Percentage of participants who showed overall response during their participation in the study. Per Modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) and assessed by tri-phasic contrast enhanced CT: Complete Response (CR), Disappearance of intratumoral enhancing area; Partial Response (PR), >=30% decrease in the sum of the diameters of enhancing area; Overall Response (OR) = CR + PR.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histological/cytological diagnosis of primary HCC
- Advanced stage HCC (Barcelona Clinic Liver Cancer [BCLC] Stage C or B per American Association for the Study of Liver Disease [AASLD] guidelines)
- At least one measurable viable tumor in the liver, ≥1 cm longest diameter (LD), using a dynamic imaging technique (arterial phase of triphasic computerized tomography [CT] scan, or dynamic contrast-enhanced magnetic resonance imaging [MRI]), and injectable under imaging-guidance (CT and/or ultrasound)
- Child-Pugh Class A
- Performance status 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
- Adequate hematological, hepatic, and renal function:
- Additional inclusion criteria exist
Exclusion Criteria:
- Histological diagnosis of cholangiocarcinoma, hepatocholangiocarcinoma, fibrolamellar carcinoma and hepatoblastoma
- Symptomatic cardiovascular disease, including but not limited to significant coronary artery disease (e.g., requiring angioplasty or stenting) or congestive heart failure within the preceding 12 months
- Current or past history of cardiovascular disease (e.g.. past history of myocardial infarction, ischemic cardiomyopathy) unless cardiology consultation and clearance has been obtained for study participation
- History of moderate or severe ascites, bleeding esophageal varices, hepatic encephalopathy or pleural effusions related to liver insufficiency within 6 months of screening
- Bulky disease patients - tumors encompassing >50% of the liver volume and / or inferior vena cava invasion
- Known significant immunodeficiency due to underlying illness (e.g., HIV/AIDS) and/or immune-suppressive medication including high-dose corticosteroids
- Ongoing severe inflammatory skin condition (as determined by the Investigator) requiring medical treatment
- History of severe eczema (as determined by the Investigator) requiring medical treatment
- Additional exclusion criteria exist
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562755
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| Study Director: | SillaJen Medical | SillaJen, Inc. |
Documents provided by SillaJen, Inc.:
| Responsible Party: | SillaJen, Inc. |
| ClinicalTrials.gov Identifier: | NCT02562755 |
| Other Study ID Numbers: |
JX594-HEP024 |
| First Posted: | September 29, 2015 Key Record Dates |
| Results First Posted: | December 16, 2020 |
| Last Update Posted: | December 16, 2020 |
| Last Verified: | December 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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Hepatocellular Carcinoma (HCC) Pexastimogene Devacirepvec (Pexa-Vec) Sorafenib GM-CSF therapy Thymidine Kinase-Deactivated Vaccinia Virus |
Oncology Recombinant Vaccinia Virus Oncolytic Virus Therapy Oncolytic virotherapy |
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Vaccinia Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases |
Liver Diseases Poxviridae Infections DNA Virus Infections Virus Diseases Infections Sorafenib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |