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| Name | Class |
|---|---|
| Symbion Research International | INDUSTRY |
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The primary objective of the study was to assess the clinical efficacy of talimogene laherparepvec in terms of tumor response rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Talimogene Laherparepvec | Experimental | Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Talimogene Laherparepvec | Drug | Up to 4 mL of 10⁸ pfu/mL/per intratumoral injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Tumor Response Rate | Objective response rate is defined as the percentage of participants with an overall best response of complete response or partial response. The objective response to treatment was assessed by computed tomography (CT) scanning or other clinical measurement using modified Response Evaluation Criteria In Solid Tumors (RECIST). Responses must have been confirmed on two visits not less than 4 weeks apart. Tumor burden for a visit was calculated as the sum of the longest diameters of all tumors identified and measured up to that visit. Tumor response at each visit was derived from tumor burden, as follows:
| From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival (OS) was calculated from the date of the first talimogene laherparepvec dose to the date of death. Median OS was estimated using the Kaplan-Meier method. | From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days |
| Time to Progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Nemunaitis, MD | Mary Crowley Medical Research Center | Principal Investigator |
| Rob Coffin, PhD | BioVex Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Cancer Center, Thornton Hospital | La Jolla | California | 92093 | United States | ||
| UCLA |
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| ID | Title | Description |
|---|---|---|
| FG000 | Talimogene Laherparepvec | Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Talimogene Laherparepvec | Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Objective Tumor Response Rate | Objective response rate is defined as the percentage of participants with an overall best response of complete response or partial response. The objective response to treatment was assessed by computed tomography (CT) scanning or other clinical measurement using modified Response Evaluation Criteria In Solid Tumors (RECIST). Responses must have been confirmed on two visits not less than 4 weeks apart. Tumor burden for a visit was calculated as the sum of the longest diameters of all tumors identified and measured up to that visit. Tumor response at each visit was derived from tumor burden, as follows:
| Intent-to-treat (ITT) population (all participants who received at least 1 dose of talimogene laherparepvec) | Posted | Number | percentage of participants | From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days |
The median (minimum, maximum) duration of treatment was 82 (1, 346) days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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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 | Talimogene Laherparepvec | Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen, Inc. | 866-572-6436 |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000629782 | talimogene laherparepvec |
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Time to progression was calculated from the date of the first talimogene laherparepvec dose to the first date of documented progressive disease (via clinical symptom or tumor burden assessment) that was not followed by a later response of CR, PR, or stable disease. Median time to progression was calculated using the Kaplan-Meier method. |
| From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days. |
| Time to Longest Continuous Response | Time to response was calculated from the date of the first talimogene laherparepvec dose to the initial date of the participant's last response interval. | From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days. |
| Duration of Response | Duration of response was calculated from the initial date of response (CR or PR) until the date of progressive disease (or until last follow up that was CR or PR). Participants could have multiple response periods; in this situation, the last response interval was used for the calculation of duration of response. | From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days. |
| Number of Participants With Adverse Events | The severity of an adverse event (AE) was graded according to Common Toxicity Criteria for Adverse Events (CTCAE) Version 3 (1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death). Serious adverse events include death, life-threatening events, events requiring or prolonging hospitalization, result in persistent or significant disability/incapacity, or a congenital anomaly/birth defect, or otherwise important medical events that may jeopardise the patient or require intervention to prevent one of the above outcomes. | From first dose of talimogene laherparepvec until 30 days after the last dose; the median (minimum, maximum) duration of treatment was 82 (1, 346) days. |
| Los Angeles |
| California |
| 90095 |
| United States |
| University of Colorado, Anschutz Cancer Pavillion | Aurora | Colorado | 80010 | United States |
| Hubert H Humphrey Cancer Center | Robbinsdale | Minnesota | 55422 | United States |
| Mountainside Hospital | Montclair | New Jersey | 07042 | United States |
| Columbia University, Department of Surgery | New York | New York | 10032 | United States |
| Mary Crowely Medical Research Center | Dallas | Texas | 75246 | United States |
| Royal Marsden Hospital | London | SW3 6JJ | United Kingdom |
| Withdrawal by Subject |
|
| Adverse Event |
|
| Other |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance | Scale used to assess how a patient's disease is progressing, how the disease affects the daily living abilities of the patient: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self care, confined to a bed or chair > 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead. | Number | participants |
|
| Tumor, Node, Metastasis (TNM) Disease Stage | Stage IIIC: Ulcerated lesion and 1 lymph node with macrometastasis; 2-3 nodes with macrometastasis or ≥ 4 metastatic lymph nodes, matted lymph nodes, or in-transit met(s)/satellite(s); Stage IV: M1a: Spread to skin, subcutaneous tissue, or lymph nodes; normal lactate dehydrogenase (LDH) level; M1b: Spread to lungs; normal LDH level; M1c: Spread to all other visceral organs, normal LDH level or any distant disease with elevated LDH level. | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Talimogene Laherparepvec | Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses. |
|
|
| Secondary | Overall Survival | Overall survival (OS) was calculated from the date of the first talimogene laherparepvec dose to the date of death. Median OS was estimated using the Kaplan-Meier method. | ITT population | Posted | Median | Full Range | days | From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days |
|
|
|
| Secondary | Time to Progression | Time to progression was calculated from the date of the first talimogene laherparepvec dose to the first date of documented progressive disease (via clinical symptom or tumor burden assessment) that was not followed by a later response of CR, PR, or stable disease. Median time to progression was calculated using the Kaplan-Meier method. | ITT population | Posted | Median | Full Range | days | From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days. |
|
|
|
| Secondary | Time to Longest Continuous Response | Time to response was calculated from the date of the first talimogene laherparepvec dose to the initial date of the participant's last response interval. | ITT population with an objective response (PR or CR) | Posted | Median | Full Range | days | From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days. |
|
|
|
| Secondary | Duration of Response | Duration of response was calculated from the initial date of response (CR or PR) until the date of progressive disease (or until last follow up that was CR or PR). Participants could have multiple response periods; in this situation, the last response interval was used for the calculation of duration of response. | ITT population with an objective response (PR or CR) | Posted | Median | Full Range | days | From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days. |
|
|
|
| Secondary | Number of Participants With Adverse Events | The severity of an adverse event (AE) was graded according to Common Toxicity Criteria for Adverse Events (CTCAE) Version 3 (1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death). Serious adverse events include death, life-threatening events, events requiring or prolonging hospitalization, result in persistent or significant disability/incapacity, or a congenital anomaly/birth defect, or otherwise important medical events that may jeopardise the patient or require intervention to prevent one of the above outcomes. | ITT population | Posted | Number | participants | From first dose of talimogene laherparepvec until 30 days after the last dose; the median (minimum, maximum) duration of treatment was 82 (1, 346) days. |
|
|
|
| 17 |
| 50 |
| 48 |
| 50 |
| Atrioventricular block complete | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Metastatic pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Tenderness | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Title | Measurements |
|---|---|
|
| Fatal adverse events |
|
| Serious adverse events |
|
| Discontinued study treatment due to adverse event |
|
| Injection site reactions |
|
| Flu-like symptoms |
|