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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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Hepatocellular Carcinoma (HCC) |
| Interventions |
Biological: Pexastimogene Devacirepvec (Pexa Vec) Drug: Sorafenib |
| Enrollment | 459 |
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Pexa-Vec Followed by Sorafenib | Sorafenib |
|---|---|---|
 Arm/Group Description |
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. 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. 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. |
Sorafenib (400 mg twice daily) begins on Day 1. 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. |
| Period Title: Overall Study | ||
| Started [1] | 234 | 225 |
| Safety Population [2] | 218 | 217 |
| Completed | 161 | 153 |
| Not Completed | 73 | 72 |
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[1]
Randomized
[2]
Patients who received at least one dose of study treatment
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| Arm/Group Title | Pexa-Vec Followed by Sorafenib | Sorafenib | Total | |
|---|---|---|---|---|
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Arm/Group Description |
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. 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. 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. |
Sorafenib (400 mg twice daily) begins on Day 1. 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. |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 234 | 225 | 459 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 234 participants | 225 participants | 459 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
133 56.8%
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148 65.8%
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281 61.2%
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| >=65 years |
101 43.2%
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77 34.2%
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178 38.8%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 234 participants | 225 participants | 459 participants | |
| 61.3 (10.05) | 60.5 (11.06) | 60.9 (10.55) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 234 participants | 225 participants | 459 participants | |
| Female |
30 12.8%
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43 19.1%
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73 15.9%
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| Male |
204 87.2%
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182 80.9%
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386 84.1%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 234 participants | 225 participants | 459 participants | |
| Hispanic or Latino |
5 2.1%
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6 2.7%
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11 2.4%
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| Not Hispanic or Latino |
229 97.9%
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219 97.3%
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448 97.6%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 234 participants | 225 participants | 459 participants |
| Singapore | 8 | 3 | 11 | |
| Hong Kong | 1 | 3 | 4 | |
| United States | 40 | 34 | 74 | |
| United Kingdom | 3 | 4 | 7 | |
| Thailand | 2 | 5 | 7 | |
| Portugal | 2 | 3 | 5 | |
| New Zealand | 27 | 27 | 54 | |
| Canada | 5 | 4 | 9 | |
| South Korea | 61 | 68 | 129 | |
| China | 42 | 40 | 82 | |
| Taiwan | 13 | 10 | 23 | |
| Italy | 1 | 3 | 4 | |
| Israel | 1 | 2 | 3 | |
| Australia | 9 | 5 | 14 | |
| France | 12 | 8 | 20 | |
| Germany | 7 | 6 | 13 | |
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ECOG performance status
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 234 participants | 225 participants | 459 participants | |
| 0 |
146 62.4%
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142 63.1%
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288 62.7%
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| 1 |
88 37.6%
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83 36.9%
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171 37.3%
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[1]
Measure Description: The ECOG Performance Status describes a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.): Grade 0, Fully active, able to carry on all pre-disease performance without restriction; Grade 1, Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
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| Name/Title: | Kyoung Soo Ha, Senior Medical Director |
| Organization: | SillaJen Biotherapeutics Inc. |
| Phone: | +1-415-281-8886 |
| EMail: | ksha@kr.sillajen.com |
| Responsible Party: | SillaJen, Inc. |
| ClinicalTrials.gov Identifier: | NCT02562755 |
| Other Study ID Numbers: |
JX594-HEP024 |
| First Submitted: | September 24, 2015 |
| First Posted: | September 29, 2015 |
| Results First Submitted: | September 22, 2020 |
| Results First Posted: | December 16, 2020 |
| Last Update Posted: | December 16, 2020 |