Cancer, Melanoma
Conditions
Keywords
Melanoma, Cancer
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALALVAC(2) Melanoma multi-antigen therapeutic vaccine
0.5 mL, 2 cycles
BIOLOGICALIntron A, Interferon alpha -2b
0.5 mL, 5 times per week for 4 weeks
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
: * A pathologically confirmed diagnosis of malignant melanoma with at least one measurable metastatic lesion with a minimum lesion size of 20 mm, based on radiological assessment (or 10 mm if assessed by spiral computed tomography \[CT\] scan ) as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Stages IIIc, IVa, or IVb only, according to the American Joint Committee on Cancer (AJCC) staging system for melanoma). Cutaneous metastasis (assessed by physical examination) must be at least 10 mm. CT scan or magnetic resonance imaging (MRI) is required to rule out brain metastases. * Patients who received prior treatment for their metastatic disease must have objective evidence of disease progression. * Aged ≥ 18 years on the day of inclusion * IRB-approved informed consent form signed * Able to attend all scheduled visits and to comply with all trial procedures * For a woman, inability to bear a child or negative serum pregnancy test * For a woman of child-bearing potential, using an effective method of contraception or abstinence during the study and at least 4 weeks after the last study treatment * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a life expectancy of at least 6 months. * Adequate hematologic, hepatic, and renal function (at pre-defined laboratory values). * Fully recovered from surgery, if applicable.
Exclusion criteria
: * Receipt of two or more previous therapies for metastatic melanoma. * Receipt of chemotherapy or another therapy for metastatic melanoma within the last four weeks * Receipt of adjuvant interferon therapy within the last six months * Concurrent receipt of radiotherapy for the metastatic disease, unless for palliative purposes * Participation in another clinical trial within the four weeks preceding the first trial treatment * Planned participation in another clinical trial during the present trial period * Known Human Immunodeficiency Virus (HIV) infection or hepatitis B (Ag HBs) or hepatitis C seropositivity * Presence of active autoimmune disease (excluding vitiligo) * Systemic hypersensitivity to bovine products or to any of the vaccine components, including egg products or Neomycin (used to prepare the vaccine), or history of a life-threatening reaction to granulocyte-macrophage colony stimulating factor (GM-CSF) or interferon (IFN)-α2b * Current alcohol or drug addiction that may interfere with the ability to comply with trial procedures * Significant co-morbid medical conditions, including pre-existing renal disease, cirrhosis, or major depression, which in the estimation of the investigator would preclude safe participation in the study or the accurate interpretation of data. * A calculated glomerular filtration rate (GFR) \<60 mL/min (based on the Cockroft-Gault formula). * Previous receipt of a modified canarypox virus (ALVAC)-based vaccine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summary of Disease Progression in Study Participants, Intent-to-treat Population | Day 0 up to 35 weeks post 1st vaccination or treatment | 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). |
| Progression-Free Survival Time by Response Evaluation Criteria in Solid Tumor (RECIST) Criteria in the Intent-to-treat Population | Day 0 - up to 35 weeks post 1st vaccination or treatment | Progression-Free Survival was assessed by the Response Evaluation Criteria in Solid Tumor criteria from the computed tomography (CT) scans, as per-protocol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Overall Objective Response in the Intent-to-treat Population | Day 0 to 32 weeks post 1st vaccination or treatment | 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. |
| Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population | Day 0 to 32 weeks post 1st vaccination or treatment | 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. |
| Best Overall Objective Response as Mean Duration of Response (Weeks) in the Intent-to-treat Population | Day 0 to 32 weeks post 1st vaccination or treatment | 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. |
| Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Day 0 to 12 months post last vaccination | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | Day 0 to 32 weeks post 1st vaccination | The Vaccine-induced increase of CD4 T-Cell positive response by antigen post-vaccination during the observation period compared to the screening values. |
| Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | Day 0 to 32 weeks post 1st vaccination | The vaccine-induced increase of CD8 T-Cell positive response by antigen post-vaccination during the observation period compared to the screening values. |
| Summary of Cellular Immune Response to the Vaccination or Treatment (Percent Regulatory T-Cells Responses) | Day 0 to 32 weeks post 1st vaccination or treatment | 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. |
Countries
Canada, United States
Participant flow
Recruitment details
Participants were enrolled from 20 May 2008 to 31 March 2009 at 8 medical centers in the US and 3 medical centers in Canada.
Pre-assignment details
A total of 23 participants who met the inclusion and exclusion criteria were enrolled and treated.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 11 |
| 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) | 12 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Cycle 1 | Adverse Event | 2 | 1 |
| Cycle 1 | Disease Progression | 2 | 6 |
| Cycle 1 | Other administrative reason | 0 | 1 |
| Cycle 1 | Unacceptable Toxicity | 1 | 0 |
Baseline characteristics
| Characteristic | Study Group 1: ALVAC Melanoma Vaccine | Study Group 2: Interferon Alpha-2b | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 10 Participants | 19 Participants |
| Age, Continuous | 52.6 Years STANDARD_DEVIATION 14.23 | 52.9 Years STANDARD_DEVIATION 14.34 | 52.8 Years STANDARD_DEVIATION 14.3 |
| Region of Enrollment Canada | 2 participants | 2 participants | 4 participants |
| Region of Enrollment United States | 9 participants | 10 participants | 19 participants |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 11 | 7 / 12 |
| serious Total, serious adverse events | 5 / 11 | 5 / 12 |
Outcome results
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
Time frame: Day 0 - up to 35 weeks post 1st vaccination or treatment
Population: The Progression-Free Survival Time were assessed in the intend-to-treat (ITT) evaluable population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Study Group 1: ALVAC Melanoma Vaccine | Progression-Free Survival Time by Response Evaluation Criteria in Solid Tumor (RECIST) Criteria in the Intent-to-treat Population | 15.9 Weeks |
| Study Group 2: Interferon Alpha-2b | Progression-Free Survival Time by Response Evaluation Criteria in Solid Tumor (RECIST) Criteria in the Intent-to-treat Population | 8.9 Weeks |
p-value: 0.9406Log Rank
p-value: 0.9179Likelihood ratio test
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).
Time frame: Day 0 up to 35 weeks post 1st vaccination or treatment
Population: The Progression-Free Survival Time were assessed in the intend-to-treat (ITT) evaluable population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group 1: ALVAC Melanoma Vaccine | Summary of Disease Progression in Study Participants, Intent-to-treat Population | Progressed or died due to any cause | 7 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Summary of Disease Progression in Study Participants, Intent-to-treat Population | Did not progress or die due to any cause | 4 Participants |
| Study Group 2: Interferon Alpha-2b | Summary of Disease Progression in Study Participants, Intent-to-treat Population | Progressed or died due to any cause | 6 Participants |
| Study Group 2: Interferon Alpha-2b | Summary of Disease Progression in Study Participants, Intent-to-treat Population | Did not progress or die due to any cause | 6 Participants |
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.
Time frame: Day 0 to 32 weeks post 1st vaccination or treatment
Population: The best overall objective response as mean duration of response were assessed in the intent-to-treat (ITT) evaluable population.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Study Group 1: ALVAC Melanoma Vaccine | Best Overall Objective Response as Mean Duration of Response (Weeks) in the Intent-to-treat Population | 16.3 Weeks |
| Study Group 2: Interferon Alpha-2b | Best Overall Objective Response as Mean Duration of Response (Weeks) in the Intent-to-treat Population | 18.3 Weeks |
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.
Time frame: Day 0 to 32 weeks post 1st vaccination or treatment
Population: The best overall objective response as number of participants responding was assessed in the intent-to-treat (ITT) evaluable population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group 1: ALVAC Melanoma Vaccine | Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population | Participants with measurable disease at baseline | 11 Particpants |
| Study Group 1: ALVAC Melanoma Vaccine | Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population | Complete Response (CR) | 0 Particpants |
| Study Group 1: ALVAC Melanoma Vaccine | Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population | Partial Response (PR) | 2 Particpants |
| Study Group 1: ALVAC Melanoma Vaccine | Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population | Stable Disease (SD) | 3 Particpants |
| Study Group 1: ALVAC Melanoma Vaccine | Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population | Not Evaluable (NE) | 0 Particpants |
| Study Group 1: ALVAC Melanoma Vaccine | Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population | Progression (PD) | 6 Particpants |
| Study Group 2: Interferon Alpha-2b | Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population | Not Evaluable (NE) | 1 Particpants |
| Study Group 2: Interferon Alpha-2b | Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population | Participants with measurable disease at baseline | 11 Particpants |
| Study Group 2: Interferon Alpha-2b | Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population | Stable Disease (SD) | 3 Particpants |
| Study Group 2: Interferon Alpha-2b | Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population | Complete Response (CR) | 0 Particpants |
| Study Group 2: Interferon Alpha-2b | Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population | Progression (PD) | 6 Particpants |
| Study Group 2: Interferon Alpha-2b | Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population | Partial Response (PR) | 1 Particpants |
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.
Time frame: Day 0 to 32 weeks post 1st vaccination or treatment
Population: The best overall objective response were assessed in the intent-to-treat (ITT) evaluable population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Group 1: ALVAC Melanoma Vaccine | Best Overall Objective Response in the Intent-to-treat Population | 18.2 Percentage of participants |
| Study Group 2: Interferon Alpha-2b | Best Overall Objective Response in the Intent-to-treat Population | 9.1 Percentage of participants |
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.
Time frame: Day 0 to 12 months post last vaccination
Population: Safety assessments were conducted in the As-treated safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Sepsis | 1 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Leukocytosis | 1 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Abdominal Pain Upper | 1 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Axillary Pain | 1 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Chest Discomfort | 1 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Chest Pain | 1 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Inflammation | 1 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Pyrexia | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Anemia | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Septic Shock | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Staphylococcal Bacteremia | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Alanine Aminotransferase (ALT) Increased | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Aspartate Aminotransferase (AST) Increased | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Gamma-Glutamyl Transferase (GGT) Increased | 1 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Neutrophil Count Decreased | 1 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | White Blood Cell Count Decreased | 1 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Hypernatremia | 1 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Hypoalbuminemia | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Hypocalcemia | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Hyponatremia | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Joint Range of Motion Decreased | 1 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Metastatic Malignant Melanoma | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Brain Edema | 1 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Cerebral Hemorrhage | 1 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Encephalopathy | 1 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Headache | 1 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Hemiplegia | 1 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Paraesthesia | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Peripheral Sensory Neuropathy | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Syncope Vasovagal | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Polyuria | 1 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Hypotension | 1 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Hypotension | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Anemia | 1 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Hypernatremia | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Leukocytosis | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Encephalopathy | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Abdominal Pain Upper | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Hypoalbuminemia | 1 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Axillary Pain | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Peripheral Sensory Neuropathy | 1 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Chest Discomfort | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Hypocalcemia | 1 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Chest Pain | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Headache | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Inflammation | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Hyponatremia | 1 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Pyrexia | 1 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Polyuria | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Sepsis | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Joint Range of Motion Decreased | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Septic Shock | 1 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Hemiplegia | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Staphylococcal Bacteremia | 1 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Metastatic Malignant Melanoma | 1 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Alanine Aminotransferase (ALT) Increased | 3 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Syncope Vasovagal | 1 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Aspartate Aminotransferase (AST) Increased | 1 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Brain Edema | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Gamma-Glutamyl Transferase (GGT) Increased | 1 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Paraesthesia | 1 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Neutrophil Count Decreased | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | Cerebral Hemorrhage | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term | White Blood Cell Count Decreased | 0 Participants |
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.
Time frame: Day 0 to 32 weeks post 1st vaccination
Population: Immunologic responses were assessed in the Per-protocol evaluable population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: gp100 pool1 | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | Screening: NYESO-1 pool 1 | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: gp100 pool2 | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | Screening: gp100 pool3 | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: gp100 pool3 | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | Screening: NYESO-1 pool 2 | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: gp100 pool4 | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | Screening: gp100 pool5 | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: gp100 pool5 | 1 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | Screening: Mart1 pool | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: gp100 pool6 | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | Screening: gp100 pool2 | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: NYESO-1 pool 1 | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | Screening: Native 15mer pool | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: NYESO-1 pool 2 | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | Screening: gp100 pool6 | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: Mart1 pool | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | Screening: 9mer pool | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: Native 15mer pool | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | Screening: gp100 pool4 | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: 9mer pool | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | Screening: gp100 pool1 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: 9mer pool | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | Screening: gp100 pool1 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | Screening: gp100 pool2 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | Screening: gp100 pool3 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | Screening: gp100 pool4 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | Screening: gp100 pool5 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | Screening: gp100 pool6 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | Screening: NYESO-1 pool 1 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | Screening: NYESO-1 pool 2 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | Screening: Mart1 pool | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | Screening: Native 15mer pool | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | Screening: 9mer pool | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: gp100 pool1 | 1 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: gp100 pool2 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: gp100 pool3 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: gp100 pool4 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: gp100 pool5 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: gp100 pool6 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: NYESO-1 pool 1 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: NYESO-1 pool 2 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: Mart1 pool | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: Native 15mer pool | 0 Participants |
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.
Time frame: Day 0 to 32 weeks post 1st vaccination
Population: Immunologic responses were assessed in the Per-protocol evaluable population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: gp100 pool1 | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | Screening: NYESO-1 pool 1 | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: gp100 pool2 | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | Screening: gp100 pool4 | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: gp100 pool3 | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | Screening: NYESO-1 pool 2 | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: gp100 pool4 | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | Screening: gp100 pool1 | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: gp100 pool5 | 1 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | Screening: Mart1 pool | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: gp100 pool6 | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | Screening: gp100 pool3 | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: NYESO-1 pool 1 | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | Screening: Native 15mer pool | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: NYESO-1 pool 2 | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | Screening: gp100 pool6 | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: Mart1 pool | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | Screening: 9mer pool | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: Native 15mer pool | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | Screening: gp100 pool2 | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: 9mer pool | 0 Participants |
| Study Group 1: ALVAC Melanoma Vaccine | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | Screening: gp100 pool5 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: 9mer pool | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | Screening: gp100 pool1 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | Screening: gp100 pool2 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | Screening: gp100 pool3 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | Screening: gp100 pool4 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | Screening: gp100 pool5 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | Screening: gp100 pool6 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | Screening: NYESO-1 pool 1 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | Screening: NYESO-1 pool 2 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | Screening: Mart1 pool | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | Screening: Native 15mer pool | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | Screening: 9mer pool | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: gp100 pool1 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: gp100 pool2 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: gp100 pool3 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: gp100 pool4 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: gp100 pool5 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: gp100 pool6 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: NYESO-1 pool 1 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: NYESO-1 pool 2 | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: Mart1 pool | 0 Participants |
| Study Group 2: Interferon Alpha-2b | Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen | 7 Weeks post 1st Vaccination: Native 15mer pool | 0 Participants |
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.
Time frame: Day 0 to 32 weeks post 1st vaccination or treatment
Population: Immunologic responses were assessed in the per-protocol evaluable population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Group 1: ALVAC Melanoma Vaccine | Summary of Cellular Immune Response to the Vaccination or Treatment (Percent Regulatory T-Cells Responses) | Cycle 1 Week 1 | 3.3 Percent Cell Count | Standard Deviation 1.42 |
| Study Group 1: ALVAC Melanoma Vaccine | Summary of Cellular Immune Response to the Vaccination or Treatment (Percent Regulatory T-Cells Responses) | Cycle 2 Week 23 | 3.3 Percent Cell Count | Standard Deviation 0.9 |
| Study Group 1: ALVAC Melanoma Vaccine | Summary of Cellular Immune Response to the Vaccination or Treatment (Percent Regulatory T-Cells Responses) | Cycle 1 Week 7 | 2.9 Percent Cell Count | Standard Deviation 0.83 |
| Study Group 1: ALVAC Melanoma Vaccine | Summary of Cellular Immune Response to the Vaccination or Treatment (Percent Regulatory T-Cells Responses) | Cycle 2 Week 32 | 4.0 Percent Cell Count | Standard Deviation 0.48 |
| Study Group 1: ALVAC Melanoma Vaccine | Summary of Cellular Immune Response to the Vaccination or Treatment (Percent Regulatory T-Cells Responses) | Screening | 2.7 Percent Cell Count | Standard Deviation 1.02 |
| Study Group 2: Interferon Alpha-2b | Summary of Cellular Immune Response to the Vaccination or Treatment (Percent Regulatory T-Cells Responses) | Cycle 2 Week 32 | 2.6 Percent Cell Count | Standard Deviation 0.07 |
| Study Group 2: Interferon Alpha-2b | Summary of Cellular Immune Response to the Vaccination or Treatment (Percent Regulatory T-Cells Responses) | Screening | 3.4 Percent Cell Count | Standard Deviation 1.24 |
| Study Group 2: Interferon Alpha-2b | Summary of Cellular Immune Response to the Vaccination or Treatment (Percent Regulatory T-Cells Responses) | Cycle 1 Week 1 | 2.3 Percent Cell Count | Standard Deviation 0.65 |
| Study Group 2: Interferon Alpha-2b | Summary of Cellular Immune Response to the Vaccination or Treatment (Percent Regulatory T-Cells Responses) | Cycle 1 Week 7 | 3.1 Percent Cell Count | Standard Deviation 1.13 |
| Study Group 2: Interferon Alpha-2b | Summary of Cellular Immune Response to the Vaccination or Treatment (Percent Regulatory T-Cells Responses) | Cycle 2 Week 23 | 3.8 Percent Cell Count | Standard Deviation 0.51 |