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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JX-594 recombinant vaccina GM-CSF | Experimental | JX-594 recombinant vaccina GM-CSF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression (TTP) | 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. | CT scans every 6 week from Week 6 up to 12 months. |
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KEY Inclusion Criteria:
KEY Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Burke, MD | Jennerex Biotherapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | 85259 | United States | ||
| University of Texas Health Science Center at San Antonio |
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| ID | Title | Description |
|---|---|---|
| FG000 | JX-594 Recombinant Vaccina GM-CSF | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | JX-594 Recombinant Vaccina GM-CSF | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | CT scans every 6 week from Week 6 up to 12 months |
|
From the date when ICF signed up to 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | JX-594 Recombinant Vaccina GM-CSF | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatic Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chills | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kyoung Soo Ha, Head of Clinical Development | Sillajen Biotherapeutics Inc. | +1-415-281-8886 | ksha@kr.sillajen.com |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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|
| Overall Survival (OS) | 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. | CT scans every 6 week from Week 6 up to 12 months |
| San Antonio |
| Texas |
| 78229 |
| United States |
| Pusan National University Hospital | Pusan | South Korea |
| Pusan National University Yangsan Hospital | Yangsan | South Korea |
| University Clinic of Navarra | Pamplona | Navarre | Spain |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Time to Progression (TTP) | 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. | Posted | Median | 95% Confidence Interval | months | CT scans every 6 week from Week 6 up to 12 months. |
|
|
|
| Secondary | Overall Survival (OS) | 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. | Posted | Median | 95% Confidence Interval | months | CT scans every 6 week from Week 6 up to 12 months |
|
|
|
| 3 |
| 16 |
| 8 |
| 16 |
| 16 |
| 16 |
| Liver Carcinoma Ruptured | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Metastases To Central Nervous System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Hepatic Failure | Hepatobiliary disorders | Systematic Assessment |
|
| Hepatorenal Syndrome | Hepatobiliary disorders | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Influenza Like Illness | General disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Oedema Peripheral | General disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Chest Discomfort | General disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Rash Pustular | Infections and infestations | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
|
| Herpes Zoster | Infections and infestations | Systematic Assessment |
|
| Acute Tonsillitis | Infections and infestations | Systematic Assessment |
|
| Skin Infection | Infections and infestations | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | Systematic Assessment |
|
| Platelet Count Decreased | Investigations | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | Systematic Assessment |
|
| Blood Bilirubin Increased | Investigations | Systematic Assessment |
|
| Eosinophil Count Increased | Investigations | Systematic Assessment |
|
| Lymphocyte Count Decreased | Investigations | Systematic Assessment |
|
| Neutrophil Count Decreased | Investigations | Systematic Assessment |
|
| Neutrophil Count Increased | Investigations | Systematic Assessment |
|
| White Blood Cell Count Decreased | Investigations | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Flank Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Productive Cough | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Cold Sweat | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash Generalised | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | Systematic Assessment |
|
| Hepatic Failure | Hepatobiliary disorders | Systematic Assessment |
|
| Hepatorenal Syndrome | Hepatobiliary disorders | Systematic Assessment |
|
| Hepatic Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Liver Carcinoma Ruptured | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Metastases To Central Nervous System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Metastases To Spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D008107 |
| Liver Diseases |