Study of Tecemotide (L-BLP25) in Participants With Stage III Unresectable Non-small Cell Lung Cancer (NSCLC) Following Primary Chemoradiotherapy
Study Details
Study Description
Brief Summary
This is a phase I/II study in Japan to evaluate the safety of EMD531444 and its effects on survival time in patients with stage III unresectable non-small cell lung cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
Phase I part is designed to evaluate the safety of EMD531444 930 microgram (mcg) dose to be used in phase II. Phase II part is designed to be conducted as randomized, double blind, placebo controlled study to compare overall survival time in all randomized subjects.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tecemotide (L-BLP25) + Cyclophosphamide Active |
Biological: Tecemotide (L-BLP25)
After receiving a single low-dose cyclophosphamide, participants will receive weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 microgram [mcg]) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) will be administered every 6 weeks until progressive disease (PD).
Other Names:
Drug: Single low dose cyclophosphamide
A single intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg/m^2) of cyclophosphamide will be administered 3 days prior to tecemotide (L-BLP25), the first vaccine treatment.
|
| Placebo Comparator: Placebo + Saline Control |
Biological: Placebo
After receiving single dose of saline, participants will receive weekly subcutaneous vaccinations with placebo that matches with tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo will be administered every 6 weeks until PD.
Other: Saline
A single dose of saline (sodium chloride, 9 grams per liter [g/L]) will be administered intravenously, 3 days prior to the start of placebo.
|
Outcome Measures
Primary Outcome Measures
- Overall Survival (OS) Time [Time from randomization to death or last day known to be alive reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014).]
OS time was defined as the time from randomization to death. Participants without event were censored at the last date known to be alive or at the clinical cut-off date (01 May 2014), whichever was earlier.
Secondary Outcome Measures
- Time To Progression (TTP) - Investigator Read [Time from randomization to PD, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014).]
TTP was defined as the time from date of randomization to date of radiological diagnosis of PD (based on Response Evaluation Criteria in Solid Tumors [RECIST] v1.0). In the event that radiological confirmation could not be obtained but participant was withdrawn from trial treatment or died due to disease progression, TTP was measured from date of randomization to the date of discontinuation of trial treatment. Participants without event who died from causes other than disease progression were censored at date of death. Participants without event who were lost to follow-up were censored at the date of lost to follow-up, except if they missed 2 consecutive scheduled doses, in which case they were considered as having disease progression at time of first missed administration. Participants without event with ongoing treatment at time of analysis, or who had stopped treatment for reasons other than PD, were censored on the date of last treatment administration.
- Progression Free Survival (PFS) Time - Investigator Read [Time from randomization to disease progression, death or last tumor assessment, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014).]
PFS time was defined as the duration from randomization to either first observation of objective PD (based on RECIST v1.0) or occurrence of death due to any cause. Participants without event still on treatment at time of analysis, or who stopped treatment for reasons other than PD or PD without radiological confirmed progression, were censored at the last imaging date. Participants without event who were lost to follow-up were censored at the date of lost to follow-up, except if they missed 2 consecutive scheduled doses, in which case they were considered as having disease progression at time of first missed administration.
- Time to Treatment Failure (TTF) [Time from randomization to discontinuation of trial treatment, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014).]
TTF was defined as the duration from date of randomization to the date of discontinuation of any trial treatment (cyclophosphamide or saline, tecemotide [L-BLP25] or placebo vaccine) for any reason as reported by the Investigator. Participants who had missed 2 consecutive scheduled doses and were subsequently lost to follow-up were considered as treatment failures with event date as date of first missed administration. Participants without event still on treatment at time of analysis were censored on the date of last treatment administration.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Receipt of concomitant or sequential chemoradiotherapy, consisting of a minimum of two cycles of platinum-based chemotherapy and a minimum radiation dose of greater than or equal to (>=) 50 Gray (Gy). Participant must have completed the primary thoracic chemoradiotherapy at least 4 weeks and no later than 12 weeks prior to randomization
-
Written informed consent given before any study-related activities are carried out.
-
Histologically or cytologically documented unresectable stage III NSCLC. Cancer stage must be confirmed and documented by Computed Tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET) scan
-
Documented stable disease or objective response, according to RECIST, after primary chemoradiotherapy for unresectable stage III disease, within four weeks prior to randomization
-
Receipt of concomitant or sequential chemoradiotherapy, consisting of a minimum of two cycles of platinum-based chemotherapy and a minimum radiation dose of >= 50 Gy
-
Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1
-
Adequate bone marrow function
-
Greater than or equal to 20 years of age
Exclusion Criteria:
-
Lung cancer-specific therapy (including surgery), other than primary chemoradiotherapy. Note: exploratory surgery before study entry is allowed
-
Immunotherapy (e.g., interferons, tumor necrosis factor [TNF], interleukins, or biological response modifiers [granulocyte macrophage colony stimulating factor , granulocyte colony stimulating factor , macrophage-colony stimulating factor ], monoclonal antibodies) received within four weeks prior to randomization
-
Malignant pleural/pericardial effusion or pleural dissemination or separate tumor nodules in the same lobe at initial diagnosis and/or at study entry
-
Past or current history of neoplasm other than lung carcinoma, except for adequately treated non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer curatively treated and with no evidence of disease for at least five years
-
Autoimmune disease
-
A recognized immunodeficiency disease including cellular immunodeficiencies, hypogamma-globulinemia, or dysgammaglobulinemia; participants who have hereditary or congenital/acquired immunodeficiencies
-
Any preexisting medical condition requiring chronic steroid or immunosuppressive therapy, including presence of diffuse radiation pneumonitis spreading out of the involved field
-
Known Hepatitis B and/or C
-
Clinically significant hepatic dysfunction
-
Clinically significant renal dysfunction
-
Clinically significant cardiac disease
-
Splenectomy
-
Infectious process that, in the opinion of the investigator, could compromise the subject's ability to mount an immune response
-
Pregnant or breast-feeding women. Participants whom the investigator considers may be at risk of pregnancy will have a pregnancy test performed per institutional standard. Male and female subjects who have a reproductive ability, unless using effective contraception as determined by the investigator throughout the study until at least 6 months after the last study treatment
-
Known drug abuse or alcohol abuse
-
Legal incapacity or limited legal capacity
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Please contact the Merck KGaA Communication Center | Darmstadt | Germany |
Sponsors and Collaborators
- Merck KGaA, Darmstadt, Germany
- Merck Serono Co., Ltd., Japan
Investigators
- Study Director: Medical Responsible, Merck KGaA, Darmstadt, Germany
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EMR063325_009
Study Results
Participant Flow
| Recruitment Details | First/last subject (informed consent, Step 2 [randomized part]): 03 Feb 2010/15 Feb 2012. Clinical data cut-off: 01 May 2014. Study completion date: 15 June 2015 |
|---|---|
| Pre-assignment Detail | Enrolled: 197 screened for eligibility; 25 excluded (mainly due to non-fulfillment of inclusion or exclusion criteria) and 172 subjects randomized. |
| Arm/Group Title | Tecemotide (L-BLP25) + Cyclophosphamide | Placebo + Saline |
|---|---|---|
| Arm/Group Description | Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 microgram [mcg]) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until progressive disease (PD) was documented. | Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented. |
| Period Title: Overall Study | ||
| STARTED | 114 | 58 |
| COMPLETED | 95 | 43 |
| NOT COMPLETED | 19 | 15 |
Baseline Characteristics
| Arm/Group Title | Tecemotide (L-BLP25) + Cyclophosphamide | Placebo + Saline | Total |
|---|---|---|---|
| Arm/Group Description | Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented. | Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented. | Total of all reporting groups |
| Overall Participants | 114 | 58 | 172 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
63.0
(9.31)
|
60.1
(9.81)
|
62.0
(9.55)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
16
14%
|
11
19%
|
27
15.7%
|
| Male |
98
86%
|
47
81%
|
145
84.3%
|
Outcome Measures
| Title | Overall Survival (OS) Time |
|---|---|
| Description | OS time was defined as the time from randomization to death. Participants without event were censored at the last date known to be alive or at the clinical cut-off date (01 May 2014), whichever was earlier. |
| Time Frame | Time from randomization to death or last day known to be alive reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014). |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all subjects randomly allocated to a treatment (tecemotide [L-BLP25] or placebo). |
| Arm/Group Title | Tecemotide (L-BLP25) + Cyclophosphamide | Placebo + Saline |
|---|---|---|
| Arm/Group Description | Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented. | Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented. |
| Measure Participants | 114 | 58 |
| Median (95% Confidence Interval) [Months] |
32.4
|
32.2
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Tecemotide (L-BLP25) + Cyclophosphamide, Placebo + Saline |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.828 |
| Comments | This trial was not powered to demonstrate statistical significance of treatment differences with respect to a statistical test, i.e., the p value being lower than a significance level of alpha (α) = 0.05. | |
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.953 | |
| Confidence Interval |
(2-Sided) 95% 0.614 to 1.479 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Cox proportional hazards regression model | |
| Title | Time To Progression (TTP) - Investigator Read |
|---|---|
| Description | TTP was defined as the time from date of randomization to date of radiological diagnosis of PD (based on Response Evaluation Criteria in Solid Tumors [RECIST] v1.0). In the event that radiological confirmation could not be obtained but participant was withdrawn from trial treatment or died due to disease progression, TTP was measured from date of randomization to the date of discontinuation of trial treatment. Participants without event who died from causes other than disease progression were censored at date of death. Participants without event who were lost to follow-up were censored at the date of lost to follow-up, except if they missed 2 consecutive scheduled doses, in which case they were considered as having disease progression at time of first missed administration. Participants without event with ongoing treatment at time of analysis, or who had stopped treatment for reasons other than PD, were censored on the date of last treatment administration. |
| Time Frame | Time from randomization to PD, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014). |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Analysis Set included all subjects randomly allocated to a treatment (tecemotide [L-BLP25] or placebo). |
| Arm/Group Title | Tecemotide (L-BLP25) + Cyclophosphamide | Placebo + Saline |
|---|---|---|
| Arm/Group Description | Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented. | Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented. |
| Measure Participants | 114 | 58 |
| Median (95% Confidence Interval) [Months] |
11.3
|
7.0
|
| Title | Progression Free Survival (PFS) Time - Investigator Read |
|---|---|
| Description | PFS time was defined as the duration from randomization to either first observation of objective PD (based on RECIST v1.0) or occurrence of death due to any cause. Participants without event still on treatment at time of analysis, or who stopped treatment for reasons other than PD or PD without radiological confirmed progression, were censored at the last imaging date. Participants without event who were lost to follow-up were censored at the date of lost to follow-up, except if they missed 2 consecutive scheduled doses, in which case they were considered as having disease progression at time of first missed administration. |
| Time Frame | Time from randomization to disease progression, death or last tumor assessment, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014). |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all subjects randomly allocated to a treatment (tecemotide [L-BLP25] or placebo). |
| Arm/Group Title | Tecemotide (L-BLP25) + Cyclophosphamide | Placebo + Saline |
|---|---|---|
| Arm/Group Description | Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented. | Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented. |
| Measure Participants | 114 | 58 |
| Median (95% Confidence Interval) [Months] |
11.6
|
8.0
|
| Title | Time to Treatment Failure (TTF) |
|---|---|
| Description | TTF was defined as the duration from date of randomization to the date of discontinuation of any trial treatment (cyclophosphamide or saline, tecemotide [L-BLP25] or placebo vaccine) for any reason as reported by the Investigator. Participants who had missed 2 consecutive scheduled doses and were subsequently lost to follow-up were considered as treatment failures with event date as date of first missed administration. Participants without event still on treatment at time of analysis were censored on the date of last treatment administration. |
| Time Frame | Time from randomization to discontinuation of trial treatment, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014). |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all subjects randomly allocated to a treatment (tecemotide [L-BLP25] or placebo). |
| Arm/Group Title | Tecemotide (L-BLP25) + Cyclophosphamide | Placebo + Saline |
|---|---|---|
| Arm/Group Description | Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented. | Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented. |
| Measure Participants | 114 | 58 |
| Median (95% Confidence Interval) [Months] |
8.0
|
6.2
|
Adverse Events
| Time Frame | Time from first dosing day of trial treatment until 42 days after last dose of trial treatment or the clinical data cut-off date (01 May 2014). | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Safety analysis set included all subjects who were treated with tecemotide [L-BLP25] or placebo. Reported treatment-emergent adverse events included events that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state. | |||
| Arm/Group Title | Tecemotide (L-BLP25) + Cyclophosphamide | Placebo + Saline | ||
| Arm/Group Description | Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented. | Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented. | ||
All Cause Mortality |
||||
| Tecemotide (L-BLP25) + Cyclophosphamide | Placebo + Saline | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Tecemotide (L-BLP25) + Cyclophosphamide | Placebo + Saline | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 24/114 (21.1%) | 12/57 (21.1%) | ||
| Blood and lymphatic system disorders | ||||
| Thrombocytopenia | 1/114 (0.9%) | 1 | 0/57 (0%) | 0 |
| Cardiac disorders | ||||
| Atrioventricular block complete | 1/114 (0.9%) | 1 | 0/57 (0%) | 0 |
| Cardiac failure | 1/114 (0.9%) | 1 | 0/57 (0%) | 0 |
| Ear and labyrinth disorders | ||||
| Vertigo positional | 0/114 (0%) | 0 | 1/57 (1.8%) | 1 |
| Endocrine disorders | ||||
| Hypothyroidism | 1/114 (0.9%) | 1 | 0/57 (0%) | 0 |
| Eye disorders | ||||
| Cataract | 0/114 (0%) | 0 | 1/57 (1.8%) | 1 |
| Macular fibrosis | 0/114 (0%) | 0 | 1/57 (1.8%) | 1 |
| Optic ischaemic neuropathy | 1/114 (0.9%) | 1 | 0/57 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Gingival cyst | 1/114 (0.9%) | 1 | 0/57 (0%) | 0 |
| Inguinal hernia | 1/114 (0.9%) | 1 | 0/57 (0%) | 0 |
| Upper gastrointestinal haemorrhage | 1/114 (0.9%) | 1 | 0/57 (0%) | 0 |
| Vomiting | 1/114 (0.9%) | 1 | 0/57 (0%) | 0 |
| Infections and infestations | ||||
| Bronchitis | 0/114 (0%) | 0 | 1/57 (1.8%) | 1 |
| Pneumonia | 1/114 (0.9%) | 1 | 3/57 (5.3%) | 3 |
| Pneumonia bacterial | 0/114 (0%) | 0 | 1/57 (1.8%) | 1 |
| Upper respiratory tract infection | 1/114 (0.9%) | 1 | 0/57 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Ankle fracture | 1/114 (0.9%) | 1 | 0/57 (0%) | 0 |
| Clavicle fracture | 1/114 (0.9%) | 1 | 0/57 (0%) | 0 |
| Compression fracture | 1/114 (0.9%) | 1 | 0/57 (0%) | 0 |
| Femur fracture | 1/114 (0.9%) | 1 | 0/57 (0%) | 0 |
| Post procedural haemorrhage | 0/114 (0%) | 0 | 1/57 (1.8%) | 1 |
| Radiation pneumonitis | 2/114 (1.8%) | 2 | 2/57 (3.5%) | 2 |
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 1/114 (0.9%) | 1 | 0/57 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Osteoarthritis | 1/114 (0.9%) | 1 | 0/57 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Gastric cancer | 1/114 (0.9%) | 1 | 0/57 (0%) | 0 |
| Malignant pleural effusion | 1/114 (0.9%) | 1 | 0/57 (0%) | 0 |
| Rectal cancer | 1/114 (0.9%) | 1 | 0/57 (0%) | 0 |
| Salivary gland cancer | 0/114 (0%) | 0 | 1/57 (1.8%) | 1 |
| Nervous system disorders | ||||
| Cerebral haemorrhage | 0/114 (0%) | 0 | 1/57 (1.8%) | 1 |
| Cerebral infarction | 0/114 (0%) | 0 | 1/57 (1.8%) | 1 |
| Depressed level of consciousness | 1/114 (0.9%) | 1 | 0/57 (0%) | 0 |
| Loss of consciousness | 1/114 (0.9%) | 1 | 0/57 (0%) | 0 |
| Psychiatric disorders | ||||
| Suicide attempt | 1/114 (0.9%) | 1 | 0/57 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnoea | 1/114 (0.9%) | 1 | 0/57 (0%) | 0 |
| Pleurisy | 1/114 (0.9%) | 1 | 0/57 (0%) | 0 |
| Pneumothorax | 1/114 (0.9%) | 1 | 0/57 (0%) | 0 |
| Vascular disorders | ||||
| Peripheral arterial occlusive disease | 1/114 (0.9%) | 1 | 0/57 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Tecemotide (L-BLP25) + Cyclophosphamide | Placebo + Saline | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 107/114 (93.9%) | 53/57 (93%) | ||
| Eye disorders | ||||
| Cataract | 1/114 (0.9%) | 1 | 3/57 (5.3%) | 3 |
| Gastrointestinal disorders | ||||
| Constipation | 12/114 (10.5%) | 12 | 2/57 (3.5%) | 2 |
| Dental caries | 2/114 (1.8%) | 2 | 3/57 (5.3%) | 3 |
| Diarrhoea | 13/114 (11.4%) | 13 | 5/57 (8.8%) | 5 |
| Nausea | 13/114 (11.4%) | 13 | 4/57 (7%) | 4 |
| Stomatitis | 1/114 (0.9%) | 1 | 4/57 (7%) | 4 |
| General disorders | ||||
| Fatigue | 7/114 (6.1%) | 7 | 6/57 (10.5%) | 6 |
| Influenza like illness | 7/114 (6.1%) | 7 | 3/57 (5.3%) | 3 |
| Injection site erythema | 10/114 (8.8%) | 10 | 1/57 (1.8%) | 1 |
| Injection site nodule | 9/114 (7.9%) | 9 | 0/57 (0%) | 0 |
| Malaise | 8/114 (7%) | 8 | 5/57 (8.8%) | 5 |
| Non-cardiac chest pain | 2/114 (1.8%) | 2 | 3/57 (5.3%) | 3 |
| Pyrexia | 5/114 (4.4%) | 5 | 3/57 (5.3%) | 3 |
| Hepatobiliary disorders | ||||
| Hepatic function abnormal | 9/114 (7.9%) | 9 | 2/57 (3.5%) | 2 |
| Infections and infestations | ||||
| Herpes zoster | 6/114 (5.3%) | 6 | 3/57 (5.3%) | 3 |
| Nasopharyngitis | 33/114 (28.9%) | 33 | 16/57 (28.1%) | 16 |
| Upper respiratory tract infection | 6/114 (5.3%) | 6 | 2/57 (3.5%) | 2 |
| Injury, poisoning and procedural complications | ||||
| Radiation pneumonitis | 36/114 (31.6%) | 36 | 14/57 (24.6%) | 14 |
| Investigations | ||||
| Weight increased | 7/114 (6.1%) | 7 | 1/57 (1.8%) | 1 |
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 12/114 (10.5%) | 12 | 1/57 (1.8%) | 1 |
| Hyperglycaemia | 1/114 (0.9%) | 1 | 5/57 (8.8%) | 5 |
| Hyperuricaemia | 2/114 (1.8%) | 2 | 6/57 (10.5%) | 6 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 7/114 (6.1%) | 7 | 3/57 (5.3%) | 3 |
| Arthritis | 3/114 (2.6%) | 3 | 3/57 (5.3%) | 3 |
| Back pain | 15/114 (13.2%) | 15 | 9/57 (15.8%) | 9 |
| Myalgia | 8/114 (7%) | 8 | 3/57 (5.3%) | 3 |
| Psychiatric disorders | ||||
| Insomnia | 4/114 (3.5%) | 4 | 5/57 (8.8%) | 5 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 9/114 (7.9%) | 9 | 3/57 (5.3%) | 3 |
| Oropharyngeal pain | 5/114 (4.4%) | 5 | 3/57 (5.3%) | 3 |
| Skin and subcutaneous tissue disorders | ||||
| Rash | 8/114 (7%) | 8 | 7/57 (12.3%) | 7 |
| Vascular disorders | ||||
| Hypertension | 3/114 (2.6%) | 3 | 6/57 (10.5%) | 6 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Merck KGaA Communication Center |
|---|---|
| Organization | Merck Serono, a division of Merck KGaA |
| Phone | +49-6151-72-5200 |
| service@merckgroup.com |
- EMR063325_009