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No safety concerns, the study was terminated due to slow enrollment. All enrolled patients were followed per protocol.
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Primary objective:
To evaluate the clinical activity of the vaccine regimen, as indicated by progression-free survival versus the clinical activity of the reference treatment.
Secondary objectives:
Safety: To describe the safety profile in both treatment groups.
Efficacy: To determine the objective clinical responses of patients in both treatment groups: complete response and partial response.
Eligible participants will be randomized to receive either a vaccine treatment consisting of a series of multi-antigen melanoma vaccine and GM-CSF injections, followed by high-dose IFN-α2b or only the high-dose IFN-α2b.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group 1: ALVAC melanoma vaccine | Experimental | Participants will receive a multi-antigen of modified canarypox virus (ALVAC[2]) melanoma vaccine and granulocyte macrophage colony stimulating factor (GM-CSF) every 3 weeks, followed by 4 weeks of high-dose interferon alpha-2b 5 times per week. |
|
| Study Group 2: Interferon alpha-2b | Active Comparator | Participants on 4 weeks of high-dose interferon alpha-2b 5 times per week. Participants who showed disease progression after Cycle 1 will be permitted to cross over to Group 1 treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALVAC(2) Melanoma multi-antigen therapeutic vaccine | Biological | 0.5 mL, 2 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Disease Progression in Study Participants, Intent-to-treat Population | Number of evaluable study participants who had died or experienced objective disease progression (no clinical objective response to treatment as evaluated by computed tomography [CT] scans or physical examination). | Day 0 up to 35 weeks post 1st vaccination or treatment |
| Progression-Free Survival Time by Response Evaluation Criteria in Solid Tumor (RECIST) Criteria in the Intent-to-treat Population | Progression-Free Survival was assessed by the Response Evaluation Criteria in Solid Tumor criteria from the computed tomography (CT) scans, as per-protocol | Day 0 - up to 35 weeks post 1st vaccination or treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population | Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | The vaccine-induced increase of CD8 T-Cell positive response by antigen post-vaccination during the observation period compared to the screening values. | Day 0 to 32 weeks post 1st vaccination |
| Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen |
Inclusion Criteria :
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson | Arizona | 85724 | United States | |||
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
| Related Info | View source |
Not provided
A total of 23 participants who met the inclusion and exclusion criteria were enrolled and treated.
Participants were enrolled from 20 May 2008 to 31 March 2009 at 8 medical centers in the US and 3 medical centers in Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group 1: ALVAC Melanoma Vaccine | Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment) |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Cycle 1 |
|
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| Intron A, Interferon alpha -2b | Biological | 0.5 mL, 5 times per week for 4 weeks |
|
|
| Day 0 to 32 weeks post 1st vaccination or treatment |
| Best Overall Objective Response in the Intent-to-treat Population | Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter. | Day 0 to 32 weeks post 1st vaccination or treatment |
| Best Overall Objective Response as Mean Duration of Response (Weeks) in the Intent-to-treat Population | Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter. | Day 0 to 32 weeks post 1st vaccination or treatment |
| Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Common Terminology Criteria for Adverse Events (CTCAE) definitions: Grade 3 is a severe adverse event; Grade 4 is a life-threatening or disabling adverse event. | Day 0 to 12 months post last vaccination |
The Vaccine-induced increase of CD4 T-Cell positive response by antigen post-vaccination during the observation period compared to the screening values. |
| Day 0 to 32 weeks post 1st vaccination |
| Summary of Cellular Immune Response to the Vaccination or Treatment (Percent Regulatory T-Cells Responses) | The immunogenicity of the treatment regimens was assessed by regulatory T-cell responses as assessed primarily by the multi-parametric intracellular cytokine staining (ICS) assay. | Day 0 to 32 weeks post 1st vaccination or treatment |
| Los Angeles |
| California |
| 90024 |
| United States |
| Aurora | Colorado | 80045 | United States |
| Atlanta | Georgia | 30322 | United States |
| Chicago | Illinois | 60611 | United States |
| St Louis | Missouri | 63110 | United States |
| Omaha | Nebraska | 68198 | United States |
| Lebanon | New Hampshire | 03756 | United States |
| Portland | Oregon | 97213 | United States |
| Bethlehem | Pennsylvania | 18015 | United States |
| Pittsburgh | Pennsylvania | 15232 | United States |
| Greenville | South Carolina | 29605 | United States |
| Dallas | Texas | 75246 | United States |
| San Antonio | Texas | 78229 | United States |
| Madison | Wisconsin | 53792 | United States |
| Hamilton | Ontario | L8V 5C2 | Canada |
| London | Ontario | Canada |
| Toronto | Ontario | M4N 3M5 | Canada |
| Montreal | Quebec | H3A 1A1 | Canada |
| Study Group 2: Interferon Alpha-2b |
Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Cycle 2 (Group 2 = Crossover) |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Study Group 1: ALVAC Melanoma Vaccine | Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment) |
| BG001 | Study Group 2: Interferon Alpha-2b | Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment) |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Other Pre-specified | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | The vaccine-induced increase of CD8 T-Cell positive response by antigen post-vaccination during the observation period compared to the screening values. | Immunologic responses were assessed in the Per-protocol evaluable population. | Posted | Number | Participants | Day 0 to 32 weeks post 1st vaccination |
|
|
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | The Vaccine-induced increase of CD4 T-Cell positive response by antigen post-vaccination during the observation period compared to the screening values. | Immunologic responses were assessed in the Per-protocol evaluable population. | Posted | Number | Participants | Day 0 to 32 weeks post 1st vaccination |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population | Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter. | The best overall objective response as number of participants responding was assessed in the intent-to-treat (ITT) evaluable population. | Posted | Number | Particpants | Day 0 to 32 weeks post 1st vaccination or treatment |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Best Overall Objective Response in the Intent-to-treat Population | Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter. | The best overall objective response were assessed in the intent-to-treat (ITT) evaluable population. | Posted | Number | Percentage of participants | Day 0 to 32 weeks post 1st vaccination or treatment |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Summary of Disease Progression in Study Participants, Intent-to-treat Population | Number of evaluable study participants who had died or experienced objective disease progression (no clinical objective response to treatment as evaluated by computed tomography [CT] scans or physical examination). | The Progression-Free Survival Time were assessed in the intend-to-treat (ITT) evaluable population. | Posted | Number | Participants | Day 0 up to 35 weeks post 1st vaccination or treatment |
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Summary of Cellular Immune Response to the Vaccination or Treatment (Percent Regulatory T-Cells Responses) | The immunogenicity of the treatment regimens was assessed by regulatory T-cell responses as assessed primarily by the multi-parametric intracellular cytokine staining (ICS) assay. | Immunologic responses were assessed in the per-protocol evaluable population. | Posted | Mean | Standard Deviation | Percent Cell Count | Day 0 to 32 weeks post 1st vaccination or treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Progression-Free Survival Time by Response Evaluation Criteria in Solid Tumor (RECIST) Criteria in the Intent-to-treat Population | Progression-Free Survival was assessed by the Response Evaluation Criteria in Solid Tumor criteria from the computed tomography (CT) scans, as per-protocol | The Progression-Free Survival Time were assessed in the intend-to-treat (ITT) evaluable population. | Posted | Median | Inter-Quartile Range | Weeks | Day 0 - up to 35 weeks post 1st vaccination or treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Best Overall Objective Response as Mean Duration of Response (Weeks) in the Intent-to-treat Population | Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter. | The best overall objective response as mean duration of response were assessed in the intent-to-treat (ITT) evaluable population. | Posted | Mean | Full Range | Weeks | Day 0 to 32 weeks post 1st vaccination or treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Common Terminology Criteria for Adverse Events (CTCAE) definitions: Grade 3 is a severe adverse event; Grade 4 is a life-threatening or disabling adverse event. | Safety assessments were conducted in the As-treated safety population. | Posted | Number | Participants | Day 0 to 12 months post last vaccination |
|
|
Adverse events data were collected from the day of vaccination for 12 months post-vaccination
Due to the very limited data on the cross over participants in Group 2, Cycle 2 (n=4), cross over data were only reflected in the serious adverse event (SAE) data. Three of the 4 participants reported Gastrointestinal perforation, chest pain, disease progression, and pneumonia SAEs during the 12 months follow-up period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Group 1: ALVAC Melanoma Vaccine | Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment) | 5 | 11 | 5 | 11 | ||
| EG001 | Study Group 2: Interferon Alpha-2b | Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment) | 5 | 12 | 7 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal Perforation | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Disease Progression | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Metastatic Malignant Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Axillary Pain | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Chest Discomfort | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Inflammation | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| ALT Increased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| AST Increased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| GGT Increased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Staphylococcal Bacteremia | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Joint Range of Motion Decreased | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Brain Edema | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Cerebral Hemorrhage | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hemiplegia | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Syncope Vasovagal | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
|
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | RegistryContactUs@sanofipasteur.com |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007438 | Introns |
| D000077190 | Interferon alpha-2 |
| ID | Term |
|---|---|
| D021901 | DNA, Intergenic |
| D040481 | Genome Components |
| D016678 | Genome |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |
| D040461 | Gene Components |
| D005796 | Genes |
| D016898 | Interferon-alpha |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Canada |
|
| Screening: gp100 pool3 |
|
| Screening: gp100 pool4 |
|
| Screening: gp100 pool5 |
|
| Screening: gp100 pool6 |
|
| Screening: NYESO-1 pool 1 |
|
| Screening: NYESO-1 pool 2 |
|
| Screening: Mart1 pool |
|
| Screening: Native 15mer pool |
|
| Screening: 9mer pool |
|
| 7 Weeks post 1st Vaccination: gp100 pool1 |
|
| 7 Weeks post 1st Vaccination: gp100 pool2 |
|
| 7 Weeks post 1st Vaccination: gp100 pool3 |
|
| 7 Weeks post 1st Vaccination: gp100 pool4 |
|
| 7 Weeks post 1st Vaccination: gp100 pool5 |
|
| 7 Weeks post 1st Vaccination: gp100 pool6 |
|
| 7 Weeks post 1st Vaccination: NYESO-1 pool 1 |
|
| 7 Weeks post 1st Vaccination: NYESO-1 pool 2 |
|
| 7 Weeks post 1st Vaccination: Mart1 pool |
|
| 7 Weeks post 1st Vaccination: Native 15mer pool |
|
| 7 Weeks post 1st Vaccination: 9mer pool |
|
|
| Participants |
|
|
| Participants |
|
|
|
|
|
|
| Participants |
|
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