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Study of Safety and Efficacy of Talimogene Laherparepvec With Cisplatin and Radiotherapy for Treatment of Locally Advanced Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT01161498
Recruitment Status : Terminated (The changing aetiology of squamous cell carcinoma of the head and neck (SCCHN).)
First Posted : July 13, 2010
Results First Posted : December 17, 2015
Last Update Posted : February 8, 2016
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
BioVex Limited

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Squamous Cell Carcinoma
Head and Neck Cancer
Interventions Biological: Talimogene Laherparepvec
Radiation: Radiation
Drug: Cisplatin
Enrollment 5
Recruitment Details This study was open to patients with advanced, non-metastatic, stage III or IV squamous cell carcinoma of the head and neck (SCCHN).
Pre-assignment Details  
Arm/Group Title Radiation/Cisplatin Talimogene Laherparepvec + Radiation/Cisplatin
Hide Arm/Group Description Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period. The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ plaque-forming units (PFU)/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
Period Title: Overall Study
Started 3 2
Completed 3 1
Not Completed 0 1
Reason Not Completed
Disease Progression             0             1
Arm/Group Title Radiation/Cisplatin Talimogene Laherparepvec + Radiation/Cisplatin Total
Hide Arm/Group Description Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period. The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period. Total of all reporting groups
Overall Number of Baseline Participants 3 2 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 2 participants 5 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
1
  50.0%
4
  80.0%
>=65 years
0
   0.0%
1
  50.0%
1
  20.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 2 participants 5 participants
Female
1
  33.3%
0
   0.0%
1
  20.0%
Male
2
  66.7%
2
 100.0%
4
  80.0%
1.Primary Outcome
Title 2-year Event-free Survival
Hide Description Event-free survival is defined as the time from randomization until the first evidence of relapse, disease progression (local, regional, metastatic, or second primary), or death from any cause. Because this study was terminated with only 5 participants enrolled, and the study was terminated in the first year, this endpoint was not analyzed.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiation/Cisplatin Talimogene Laherparepvec + Radiation/Cisplatin
Hide Arm/Group Description:
Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Clinical Objective Response (cOR)
Hide Description

Tumor response was assessed by computed tomography (CT) scan according to a modified version of the revised Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1). Objective response is defined as achieving a clinical partial response (cPR) or complete response (cCR). cCR is defined as disappearance of all baseline lesions. Any pathological lymph nodes must have a reduction in short axis to < 10 mm. cPR is defined as at least a 30% decrease in the sum of diameters of baseline lesions. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of baseline lesions, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm, or the appearance of any new lesions.

Because this study was terminated with 5 patients enrolled, data for this endpoint were summarized in by-patient listings only and the cOR rate was not calculated. Therefore a summary of response at the end of study is reported.

Time Frame End of trial; the maximum time on study was 20 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Radiation/Cisplatin Talimogene Laherparepvec + Radiation/Cisplatin
Hide Arm/Group Description:
Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
Overall Number of Participants Analyzed 3 2
Measure Type: Number
Unit of Measure: participants
Clinical Complete Response (cCR) 2 1
Clinical Partial Response (cPR) 0 0
Progressive Disease 1 0
Unevaluable 0 1
3.Secondary Outcome
Title Metabolic Complete Response (mCR)
Hide Description

Response to therapy was assessed using [(18)F] fluorodeoxyglucose positron emission tomography (FDG PET) imaging to detect metabolically active tumors.

Metabolic complete response (mCR) is defined as complete disappearance of FDG uptake attributable to tumor compared to baseline scan.

Partial metabolic response (mPR) is defined as a > 40% decrease in specific uptake compared to the initial value in over half of the lesions.

Disease progression (mPD) is defined as a specific uptake increase in any lesion, appearance of new lesions, or presence of extended areas of disease activity.

Stable metabolic response (mSD) is defined as a decrease in uptake < 40% of the initial value of over half the lesions.

Because this study was terminated with 5 patients enrolled, data for this endpoint were summarized in by-patient listings only and the metabolic complete response rate was not calculated. Therefore a summary of metabolic response at end of study is reported.

Time Frame End of study; the maximum time on study was 20 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Radiation/Cisplatin Talimogene Laherparepvec + Radiation/Cisplatin
Hide Arm/Group Description:
Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
Overall Number of Participants Analyzed 3 2
Measure Type: Number
Unit of Measure: participants
Metabolic Complete Response (mCR) 1 1
Metabolic Partial Response (mPR) 0 0
Metabolic Progressive Disease (mPD) 1 0
Stable Metabolic Response (mSD) 0 0
Unevaluable 1 1
4.Secondary Outcome
Title Pathologic Complete Response (mCR)
Hide Description

Response to therapy was assessed histopathologically from biopsies taken at surgery for those participants who had surgery prior to Week 22.

If no viable tumor cells were identified in surgical specimens (where the patient had surgery) the patient was classified as having a pathological complete response (pCR), and if viable tumor cells were identified, the patient was classified as having an incomplete pathologic response.

Because this study was terminated with 5 patients enrolled, data for this endpoint were summarized in by-patient listings only and the pathologic complete response rate was not calculated. Therefore a summary of participants with a pathologic complete response before the end of study is reported.

Time Frame Up to Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who had protocol-specified surgery
Arm/Group Title Radiation/Cisplatin Talimogene Laherparepvec + Radiation/Cisplatin
Hide Arm/Group Description:
Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
Overall Number of Participants Analyzed 1 0
Measure Type: Number
Unit of Measure: participants
0
5.Secondary Outcome
Title Time to Locoregional Failure
Hide Description

Locoregional failure is defined as disease progression in the head and neck area at any time following completion of chemoradiotherapy.

Because this study was terminated with 5 subjects enrolled, time to locoregional failure was not analyzed.

Time Frame Up to 27 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiation/Cisplatin Talimogene Laherparepvec + Radiation/Cisplatin
Hide Arm/Group Description:
Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Time to Distant Failure
Hide Description

Distant failure is defined as disease progression at any site other than the head and neck area at any time following completion of chemoradiotherapy.

Because this study was terminated with 5 participants enrolled, time to distant failure was not analyzed.

Time Frame Up to 27 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiation/Cisplatin Talimogene Laherparepvec + Radiation/Cisplatin
Hide Arm/Group Description:
Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Time to Any Failure
Hide Description

Any failure is defined as disease progression at any site at any time following completion of chemoradiotherapy.

Because this study was terminated with 5 participants enrolled, time to any failure was not analyzed.

Time Frame Up to 27 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiation/Cisplatin Talimogene Laherparepvec + Radiation/Cisplatin
Hide Arm/Group Description:
Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Overall Survival
Hide Description

Overall survival is defined as the time from randomization to death from any cause.

Because this study was terminated with 5 participants enrolled, overall survival was not analyzed.

Time Frame Up to 5 years after chemoradiotherapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiation/Cisplatin Talimogene Laherparepvec + Radiation/Cisplatin
Hide Arm/Group Description:
Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Disease-specific Survival
Hide Description

Disease-specific survival is defined as the time from randomization to death of the patient due to the cancer under study.

Because this study was terminated with 5 participants enrolled, disease-specific survival was not analyzed.

Time Frame Up to 5 years after chemoradiotherapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiation/Cisplatin Talimogene Laherparepvec + Radiation/Cisplatin
Hide Arm/Group Description:
Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Participants With N1-2 Disease at Baseline Requiring Neck Dissection
Hide Description Participants with Baseline Nl or N2 disease (lymph node metastasis not more than 6 cm in greatest dimension) with persistent disease as determined at the post chemoradiotherapy assessment of response were to proceed to neck dissection as permitted by the institution no later than Week 22. Since this study terminated prematurely neck dissection data were not collected or analyzed.
Time Frame Weeks 19 - 21
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiation/Cisplatin Talimogene Laherparepvec + Radiation/Cisplatin
Hide Arm/Group Description:
Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 20 weeks
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title Radiation/Cisplatin Talimogene Laherparepvec + Radiation/Cisplatin
Hide Arm/Group Description Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period. The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
All-Cause Mortality
Radiation/Cisplatin Talimogene Laherparepvec + Radiation/Cisplatin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Radiation/Cisplatin Talimogene Laherparepvec + Radiation/Cisplatin
Affected / at Risk (%) Affected / at Risk (%)
Total   2/3 (66.67%)   2/2 (100.00%) 
Gastrointestinal disorders     
Mouth haemorrhage  1  1/3 (33.33%)  0/2 (0.00%) 
Infections and infestations     
Lung infection  1  0/3 (0.00%)  1/2 (50.00%) 
Urinary tract infection  1  0/3 (0.00%)  1/2 (50.00%) 
Metabolism and nutrition disorders     
Dehydration  1  1/3 (33.33%)  0/2 (0.00%) 
Hyperglycaemia  1  0/3 (0.00%)  1/2 (50.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant neoplasm progression  1  0/3 (0.00%)  1/2 (50.00%) 
Renal and urinary disorders     
Renal failure acute  1  0/3 (0.00%)  1/2 (50.00%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion  1  0/3 (0.00%)  1/2 (50.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Radiation/Cisplatin Talimogene Laherparepvec + Radiation/Cisplatin
Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   2/2 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  2/3 (66.67%)  0/2 (0.00%) 
Neutropenia  1  1/3 (33.33%)  0/2 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  0/3 (0.00%)  2/2 (100.00%) 
Constipation  1  1/3 (33.33%)  1/2 (50.00%) 
Diarrhoea  1  1/3 (33.33%)  2/2 (100.00%) 
Dry mouth  1  0/3 (0.00%)  1/2 (50.00%) 
Dyspepsia  1  1/3 (33.33%)  0/2 (0.00%) 
Dysphagia  1  0/3 (0.00%)  1/2 (50.00%) 
Gastrooesophageal reflux disease  1  0/3 (0.00%)  1/2 (50.00%) 
Impaired gastric emptying  1  0/3 (0.00%)  1/2 (50.00%) 
Nausea  1  1/3 (33.33%)  2/2 (100.00%) 
Odynophagia  1  0/3 (0.00%)  1/2 (50.00%) 
Oral dysaesthesia  1  0/3 (0.00%)  1/2 (50.00%) 
Saliva altered  1  1/3 (33.33%)  0/2 (0.00%) 
Salivary duct inflammation  1  1/3 (33.33%)  2/2 (100.00%) 
Stomatitis  1  3/3 (100.00%)  1/2 (50.00%) 
Vomiting  1  2/3 (66.67%)  1/2 (50.00%) 
General disorders     
Catheter site erythema  1  1/3 (33.33%)  0/2 (0.00%) 
Fatigue  1  1/3 (33.33%)  1/2 (50.00%) 
Pain  1  1/3 (33.33%)  0/2 (0.00%) 
Infections and infestations     
Lung infection  1  0/3 (0.00%)  1/2 (50.00%) 
Oral candidiasis  1  0/3 (0.00%)  1/2 (50.00%) 
Postoperative wound infection  1  0/3 (0.00%)  1/2 (50.00%) 
Upper respiratory tract infection  1  1/3 (33.33%)  0/2 (0.00%) 
Urinary tract infection  1  0/3 (0.00%)  1/2 (50.00%) 
Investigations     
Blood creatinine increased  1  0/3 (0.00%)  1/2 (50.00%) 
Body temperature increased  1  1/3 (33.33%)  0/2 (0.00%) 
Electrocardiogram QT prolonged  1  0/3 (0.00%)  1/2 (50.00%) 
Weight decreased  1  1/3 (33.33%)  1/2 (50.00%) 
Metabolism and nutrition disorders     
Dehydration  1  1/3 (33.33%)  1/2 (50.00%) 
Hypercalcaemia  1  1/3 (33.33%)  0/2 (0.00%) 
Hypomagnesaemia  1  1/3 (33.33%)  0/2 (0.00%) 
Hyponatraemia  1  1/3 (33.33%)  0/2 (0.00%) 
Hypophagia  1  0/3 (0.00%)  1/2 (50.00%) 
Musculoskeletal and connective tissue disorders     
Muscular weakness  1  0/3 (0.00%)  1/2 (50.00%) 
Musculoskeletal chest pain  1  0/3 (0.00%)  1/2 (50.00%) 
Nervous system disorders     
Dizziness  1  0/3 (0.00%)  1/2 (50.00%) 
Dysgeusia  1  0/3 (0.00%)  1/2 (50.00%) 
Psychiatric disorders     
Delirium  1  0/3 (0.00%)  1/2 (50.00%) 
Depression  1  0/3 (0.00%)  1/2 (50.00%) 
Insomnia  1  0/3 (0.00%)  1/2 (50.00%) 
Renal and urinary disorders     
Dysuria  1  0/3 (0.00%)  1/2 (50.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/3 (33.33%)  1/2 (50.00%) 
Hypoxia  1  0/3 (0.00%)  1/2 (50.00%) 
Laryngeal oedema  1  0/3 (0.00%)  1/2 (50.00%) 
Nasal congestion  1  1/3 (33.33%)  0/2 (0.00%) 
Oropharyngeal pain  1  0/3 (0.00%)  1/2 (50.00%) 
Pleural effusion  1  0/3 (0.00%)  1/2 (50.00%) 
Pneumothorax  1  0/3 (0.00%)  1/2 (50.00%) 
Productive cough  1  1/3 (33.33%)  1/2 (50.00%) 
Skin and subcutaneous tissue disorders     
Decubitus ulcer  1  0/3 (0.00%)  1/2 (50.00%) 
Erythema  1  1/3 (33.33%)  0/2 (0.00%) 
Skin ulcer  1  0/3 (0.00%)  1/2 (50.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Study Director
Organization: Amgen, Inc.
Phone: 866-572-6436
Responsible Party: BioVex Limited
ClinicalTrials.gov Identifier: NCT01161498     History of Changes
Other Study ID Numbers: 006/09
20110130 ( Other Identifier: Amgen Inc. )
First Submitted: July 12, 2010
First Posted: July 13, 2010
Results First Submitted: November 12, 2015
Results First Posted: December 17, 2015
Last Update Posted: February 8, 2016