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Evaluation of a New Vaccine Treatment for Patients With Metastatic Skin Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01149343
Recruitment Status : Completed
First Posted : June 23, 2010
Results First Posted : August 31, 2018
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Melanoma
Intervention Biological: Immunotherapeutic GSK2302025A, different formulations
Enrollment 107
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GSK2302025A Cohort 1 GSK2302025A Cohort 2 GSK2302025A Cohort 3 GSK2302025A Cohort 4
Hide Arm/Group Description Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4. Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4. Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4. In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
Period Title: Overall Study
Started [1] 20 24 22 40
Completed 0 0 0 0
Not Completed 20 24 22 40
Reason Not Completed
Withdrawal by Subject             1             1             1             5
Death             10             13             18             18
Lost to Follow-up             1             0             0             1
Other             8             10             2             14
Sponsor study termination             0             0             0             2
Recurrence / Progressive disease             0             0             1             0
[1]
107 patients were treated, 106 patients have 1 dose of vaccine assigned in the randomization system
Arm/Group Title GSK2302025A Cohort 1 GSK2302025A Cohort 2 GSK2302025A Cohort 3 GSK2302025A Cohort 4 Total
Hide Arm/Group Description Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4. Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4. Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4. In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic. Total of all reporting groups
Overall Number of Baseline Participants 20 24 22 40 106
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 24 participants 22 participants 40 participants 106 participants
60.3  (14.9) 60.8  (15.5) 59.5  (15.2) 60.7  (18.1) 60.4  (16.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 24 participants 22 participants 40 participants 106 participants
Female
7
  35.0%
11
  45.8%
10
  45.5%
29
  72.5%
57
  53.8%
Male
13
  65.0%
13
  54.2%
12
  54.5%
11
  27.5%
49
  46.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Geographic Ancestry Number Analyzed 20 participants 24 participants 22 participants 40 participants 106 participants
White - Caucasian / European Heritage
20
 100.0%
23
  95.8%
21
  95.5%
40
 100.0%
104
  98.1%
Unspecified
0
   0.0%
1
   4.2%
1
   4.5%
0
   0.0%
2
   1.9%
1.Primary Outcome
Title Number of Patients With Dose-limiting Toxicity (Phase I)
Hide Description

The dose-limiting toxicities (DLT) were defined as follows:

  • An Antigen-Specific Cancer Immunotherapeutic (ASCI) related or possibly ASCI related grade 3 or higher toxicity. Grade 3 myalgia, arthralgia, headache, fever, rigors/chills and fatigue (including lethargy, malaise and asthenia) persisting for 48 hours despite therapy.
  • An ASCI related or possibly ASCI related grade 2 or higher allergic reaction occurring within 24 hours following the ASCI administration.
  • An ASCI related or possibly ASCI related decrease in renal function, with a creatinine clearance lower than (<) 40 milliliters per minute (mL/min).
  • An ASCI-related or possibly ASCI-related symptomatic and confirmed adrenal insufficiency. The grading used was defined according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0: Grade 3 DLT = severe DLT. Related = DLT considered by investigator as possibly related to product administration.
Time Frame During the study treatment (up to Year 4), for all patients
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on Phase 1 subjects from the Total treated population, which included all enrolled patients who have received at least one study dose injection.
Arm/Group Title GSK2302025A Cohort 1 GSK2302025A Cohort 2 GSK2302025A Cohort 3
Hide Arm/Group Description:
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Overall Number of Participants Analyzed 20 24 22
Measure Type: Count of Participants
Unit of Measure: Participants
Patients with DLT
0
   0.0%
1
   4.2%
1
   4.5%
Patients with related DLT
0
   0.0%
1
   4.2%
1
   4.5%
Patients with severe DLT
0
   0.0%
1
   4.2%
1
   4.5%
Brain oedema
0
   0.0%
1
   4.2%
0
   0.0%
Microalbuminuria
0
   0.0%
0
   0.0%
1
   4.5%
Proteinuria
0
   0.0%
0
   0.0%
1
   4.5%
2.Primary Outcome
Title Percentage of Patients With Anti-PReferentially Expressed Antigen of MElanoma (Anti-PRAME) Humoral Immune Response (Phase I)
Hide Description A seronegative/seropositive patient for anti-PRAME antibodies was a patient with antibody concentration lower (<)/ higher than or equal to (≥) cut-off level. Humoral immune response was defined as a) if baseline concentration < cut-off level: post treatment concentration ≥ cut-off level, or b) if baseline concentration ≥ cut-off level: post treatment concentration at least twice the baseline value. Cut-off values for seropositivity (by enzyme-linked immunosorbent assay [ELISA]) were 12 ELISA Units per milliliter (EL.U/mL).
Time Frame After the administration of dose 4, at Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on Phase 1 subjects with available results at Week 8, from the Total treated population, which included all enrolled patients who have received at least one study dose injection.
Arm/Group Title GSK2302025A Cohort 1 GSK2302025A Cohort 2 GSK2302025A Cohort 3
Hide Arm/Group Description:
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Overall Number of Participants Analyzed 13 13 17
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
100
(75.3 to 100)
100
(75.3 to 100)
100
(80.5 to 100)
3.Primary Outcome
Title Number of Patients With Best Overall Response to Study Treatment (Phase II)
Hide Description The best overall response is the best response recorded from the start of the treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started). In general the patient's best response assignment depended on the achievement of both measurement and confirmation criteria. The best overall response includes the complete response (CR) defined as disappearance of all targeted/non-targeted lesions and partial response (PR) defined as at least 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD and persistence of one or more non-targeted lesion(s).
Time Frame During the entire study period - up to Year 4 + 1 month post last study treatment administration
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.
Arm/Group Title GSK2302025A Cohort 1 GSK2302025A Cohort 2 GSK2302025A Cohort 3 GSK2302025A Cohort 4
Hide Arm/Group Description:
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
Overall Number of Participants Analyzed 20 24 22 40
Measure Type: Count of Participants
Unit of Measure: Participants
Patients with CR
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Patients with PR
0
   0.0%
0
   0.0%
0
   0.0%
4
  10.0%
4.Secondary Outcome
Title Number of Patients With Any Unsolicited Adverse Events (AEs), by Maximum Grading
Hide Description An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. The grading to be used by the investigators for the assessment of the severity of adverse events (AEs) was defined as the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 (Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe or medically significant; Grade 4 = life-threatening; Grade 5 = death related to AE). Adverse Events were coded to the preferred term (PT) level by means of the Medical Dictionary for Regulatory Activities (MedDRA).
Time Frame During the entire study period - up to Year 4 + 1 month post last study treatment administration
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.
Arm/Group Title GSK2302025A Cohort 1 GSK2302025A Cohort 2 GSK2302025A Cohort 3 GSK2302025A Cohort 4
Hide Arm/Group Description:
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
Overall Number of Participants Analyzed 20 24 22 40
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
9
  45.0%
9
  37.5%
8
  36.4%
12
  30.0%
Grade 2
6
  30.0%
6
  25.0%
10
  45.5%
15
  37.5%
Grade 3
4
  20.0%
5
  20.8%
3
  13.6%
7
  17.5%
Grade 4
1
   5.0%
1
   4.2%
0
   0.0%
3
   7.5%
Grade 5
0
   0.0%
0
   0.0%
0
   0.0%
2
   5.0%
5.Secondary Outcome
Title Number of Patients With Serious Adverse Events (SAEs), by Maximum Grading
Hide Description Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. The grading to be used by the investigators for the assessment of the severity of adverse events (AEs) was defined as the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 (Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe or medically significant; Grade 4 = life-threatening; Grade 5 = death related to AE). SAEs were coded to the preferred term (PT) level by means of the Medical Dictionary for Regulatory Activities (MedDRA).
Time Frame During the entire study period - up to Year 4 + 1 month post last study treatment administration
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.
Arm/Group Title GSK2302025A Cohort 1 GSK2302025A Cohort 2 GSK2302025A Cohort 3 GSK2302025A Cohort 4
Hide Arm/Group Description:
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
Overall Number of Participants Analyzed 20 24 22 40
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 2
0
   0.0%
0
   0.0%
1
   4.5%
0
   0.0%
Grade 3
2
  10.0%
2
   8.3%
1
   4.5%
0
   0.0%
Grade 4
1
   5.0%
1
   4.2%
0
   0.0%
3
   7.5%
Grade 5
0
   0.0%
0
   0.0%
0
   0.0%
2
   5.0%
6.Secondary Outcome
Title Number of Patients With Laboratory Abnormalities Versus Baseline, by Maximum Grading
Hide Description Laboratory abnormalities belong to hematological and biochemical parameters such as: activated partial thromboplastin time prolonged [APTTP], alanine aminotransferase increased [ALT/I], alkaline phoshatase increased [APH/I], anemia [AN], asparatate aminostransferase increased [AST/I], blood bilirubin increased [BB/I], creatinine increased [CRE/I], gamma glumatymtransferase increased [GGT/I], hemoglobin increased [Hgb/I], hypoalbuminemia [HYP], lymphocyte count decreased [LYMC/D], lymphocyte count increased [LYMC/I], neutrophil count decreased [ NEUC/D], platelet count decreased [PLA/D], white blood cell decreased [WBC/D]. Parameter grades (G0,1,2,3,4,Unknown) were compared to each baseline parameter grade (GUnknown,0,1,2,3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009 [http://evs.nci.nih.gov/ftp1/CTCAE]. This endpoint presents values for [APTTP] grading versus baseline parameter grading.
Time Frame During the entire study period - up to Year 4 + 1 month post last study treatment administration
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.
Arm/Group Title GSK2302025A Cohort 1 GSK2302025A Cohort 2 GSK2302025A Cohort 3 GSK2302025A Cohort 4
Hide Arm/Group Description:
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
Overall Number of Participants Analyzed 20 24 22 40
Measure Type: Count of Participants
Unit of Measure: Participants
[APTTP], G0-GUnknown
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[APTTP], G1-GUnknown
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[APTTP], G2-GUnknown
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[APTTP], G3-GUnknown
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.5%
[APTTP], G4-GUnknown
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[APTTP], GUknown-GUnknown
2
  10.0%
0
   0.0%
1
   4.5%
0
   0.0%
[APTTP], G0-G0
13
  65.0%
16
  66.7%
18
  81.8%
33
  82.5%
[APTTP], G1-G0
2
  10.0%
3
  12.5%
1
   4.5%
3
   7.5%
[APTTP], G2-G0
0
   0.0%
0
   0.0%
1
   4.5%
0
   0.0%
[APTTP], G3-G0
0
   0.0%
1
   4.2%
0
   0.0%
1
   2.5%
[APTTP], G4-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[APTTP], GUnknown-G0
2
  10.0%
0
   0.0%
1
   4.5%
0
   0.0%
[APTTP], G0-G1
0
   0.0%
1
   4.2%
0
   0.0%
1
   2.5%
[APTTP], G1-G1
0
   0.0%
2
   8.3%
0
   0.0%
0
   0.0%
[APTTP], G2-G1
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.5%
[APTTP], G3-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[APTTP], G4-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[APTTP], GUnknown-G1
0
   0.0%
1
   4.2%
0
   0.0%
0
   0.0%
[APTTP], G0-G2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[APTTP], G1-G2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[APTTP], G2-G2
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
[APTTP], G3-G2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[APTTP], G4-G2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[APTTP], GUknown-G2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
Hide Description Laboratory abnormalities belong to hematological and biochemical parameters such as: activated partial thromboplastin time prolonged [APTTP], alanine aminotransferase increased [ALT/I], alkaline phoshatase increased [APH/I], anemia [AN], asparatate aminostransferase increased [AST/I], blood bilirubin increased [BB/I], creatinine increased [CRE/I], gamma glumatymtransferase increased [GGT/I], hemoglobin increased [Hgb/I], hypoalbuminemia [HYP], lymphocyte count decreased [LYMC/D], lymphocyte count increased [LYMC/I], neutrophil count decreased [ NEUC/D], platelet count decreased [PLA/D], white blood cell decreased [WBC/D]. Parameter grades (G0,1,2,3,4,Uknown) were compared to each baseline parameter grade (GUnknown,0,1,2,3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009 [http://evs.nci.nih.gov/ftp1/CTCAE]. This endpoint presents values for [ALT/I] and [APH/I] grading versus baseline parameter grading.
Time Frame During the entire study period - up to Year 4 + 1 month post last study treatment administration
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.
Arm/Group Title GSK2302025A Cohort 1 GSK2302025A Cohort 2 GSK2302025A Cohort 3 GSK2302025A Cohort 4
Hide Arm/Group Description:
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
Overall Number of Participants Analyzed 20 22 24 40
Measure Type: Count of Participants
Unit of Measure: Participants
[ALT/I], G0-G0
11
  55.0%
18
  81.8%
16
  66.7%
34
  85.0%
[ALT/I], G1-G0
4
  20.0%
4
  18.2%
5
  20.8%
1
   2.5%
[ALT/I], G2-G0
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.5%
[ALT/I], G3-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[ALT/I], G4-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[ALT/I], GUknown-G0
2
  10.0%
0
   0.0%
1
   4.2%
0
   0.0%
[ALT/I], G0-G1
0
   0.0%
2
   9.1%
0
   0.0%
1
   2.5%
[ALT/I], G1-G1
3
  15.0%
0
   0.0%
0
   0.0%
3
   7.5%
[ALT/I], G2-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[ALT/I], G3-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[ALT/I], G4-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[ALT/I], GUknown-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[APH/I], G0-G0
16
  80.0%
20
  90.9%
15
  62.5%
33
  82.5%
[APH/I], G1-G0
1
   5.0%
3
  13.6%
5
  20.8%
5
  12.5%
[APH/I], G2-G0
0
   0.0%
0
   0.0%
1
   4.2%
1
   2.5%
[APH/I], G3-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[APH/I], G4-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[APH/I], GUknown-G0
2
  10.0%
0
   0.0%
1
   4.2%
0
   0.0%
[APH/I], G0-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[APH/I], G1-G1
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.5%
[APH/I], G2-G1
0
   0.0%
1
   4.5%
0
   0.0%
0
   0.0%
[APH/I], G3-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[APH/I], G4-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[APH/I], GUknokwn-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[APH/I], G0-G2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[APH/I], G1-G2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[APH/I], G2-G2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[APH/I], G3-G2
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
[APH/I], G4-G2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[APH/I], GUknown-G2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
Hide Description Laboratory abnormalities belong to hematological and biochemical parameters such as: activated partial thromboplastin time prolonged [APTTP], alanine aminotransferase increased [ALT/I], alkaline phoshatase increased [APH/I], anemia [AN], asparatate aminostransferase increased [AST/I], blood bilirubin increased [BB/I], creatinine increased [CRE/I], gamma glumatymtransferase increased [GGT/I], hemoglobin increased [Hgb/I], hypoalbuminemia [HYP], lymphocyte count decreased [LYMC/D], lymphocyte count increased [LYMC/I], neutrophil count decreased [ NEUC/D], platelet count decreased [PLA/D], white blood cell decreased [WBC/D]. Parameter grades (G0,1,2,3,4,Uknown) were compared to baseline parameter grades (GUnknown,0,1,2,3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009 [http://evs.nci.nih.gov/ftp1/CTCAE]. This endpoint presents values for [AN], [AST/I] and [CRE/I] grading versus baseline parameter grading.
Time Frame During the entire study period - up to Year 4 + 1 month post last study treatment administration
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.
Arm/Group Title GSK2302025A Cohort 1 GSK2302025A Cohort 2 GSK2302025A Cohort 3 GSK2302025A Cohort 4
Hide Arm/Group Description:
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
Overall Number of Participants Analyzed 20 24 22 40
Measure Type: Count of Participants
Unit of Measure: Participants
[AN], G0-G0
12
  60.0%
10
  41.7%
10
  45.5%
21
  52.5%
[AN], G1-G0
1
   5.0%
6
  25.0%
5
  22.7%
12
  30.0%
[AN], G2-G0
0
   0.0%
0
   0.0%
1
   4.5%
3
   7.5%
[AN], G3-G0
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
[AN], G4-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[AN], GUknown-G0
1
   5.0%
0
   0.0%
1
   4.5%
0
   0.0%
[AN], G0-G1
2
  10.0%
1
   4.2%
0
   0.0%
0
   0.0%
[AN], G1-G1
2
  10.0%
5
  20.8%
5
  22.7%
4
  10.0%
[AN], G2-G1
0
   0.0%
1
   4.2%
0
   0.0%
0
   0.0%
[AN], G3-G1
0
   0.0%
1
   4.2%
0
   0.0%
0
   0.0%
[AN], G4-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[AN], GUnknown-G1
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
[AST/I], G0-G0
13
  65.0%
18
  75.0%
17
  77.3%
36
  90.0%
[AST/I], G1-G0
3
  15.0%
6
  25.0%
4
  18.2%
2
   5.0%
[AST/I], G2-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[AST/I], G3-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[AST/I], G4-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[AST/I], GUnknown-G0
1
   5.0%
0
   0.0%
1
   4.5%
0
   0.0%
[AST/I], G0-G1
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
[AST/I], G1-G1
1
   5.0%
0
   0.0%
0
   0.0%
2
   5.0%
[AST/I], G2-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[AST/I], G3-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[AST/I], G4-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[AST/I], GUnknown-G1
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
[BB/I], G0-G0
16
  80.0%
21
  87.5%
19
  86.4%
38
  95.0%
[BB/I], G1-G0
1
   5.0%
2
   8.3%
1
   4.5%
0
   0.0%
[BB/I], G2-G0
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
[BB/I], G3-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[BB/I], G4-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[BB/I], GUnknown-G0
2
  10.0%
0
   0.0%
1
   4.5%
0
   0.0%
[BB/I], G0-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[BB/I], G1-G1
0
   0.0%
1
   4.2%
1
   4.5%
1
   2.5%
[BB/I], G2-G1
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.5%
[BB/I], G3-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[BB/I], G4-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[BB/I], GUnknown-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
Hide Description Laboratory abnormalities belong to hematological and biochemical parameters such as: activated partial thromboplastin time prolonged [APTTP], alanine aminotransferase increased [ALT/I], alkaline phoshatase increased [APH/I], anemia [AN], asparatate aminostransferase increased [AST/I], blood bilirubin increased [BB/I], creatinine increased [CRE/I], gamma glumatymtransferase increased [GGT/I], hemoglobin increased [Hgb/I], hypoalbuminemia [HYP], lymphocyte count decreased [LYMC/D], lymphocyte count increased [LYMC/I], neutrophil count decreased [ NEUC/D], platelet count decreased [PLA/D], white blood cell decreased [WBC/D]. Parameter grades (G0,1,2,3,4,Uknown) were compared to baseline parameter grades (GUnknown,0,1,2,3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009 [http://evs.nci.nih.gov/ftp1/CTCAE]. This endpoint presents values for [CRE/I] and [GGT/I] grading versus baseline parameter grading.
Time Frame During the entire study period - up to Year 4 + 1 month post last study treatment administration
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.
Arm/Group Title GSK2302025A Cohort 1 GSK2302025A Cohort 2 GSK2302025A Cohort 3 GSK2302025A Cohort 4
Hide Arm/Group Description:
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
Overall Number of Participants Analyzed 20 24 22 40
Measure Type: Count of Participants
Unit of Measure: Participants
[CRE/I], G0-G0
20
 100.0%
22
  91.7%
20
  90.9%
33
  82.5%
[CRE/I], G1-G0
0
   0.0%
0
   0.0%
1
   4.5%
6
  15.0%
[CRE/I], G2-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[CRE/I], G3-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[CRE/I], G4-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[CRE/I], GUnknown-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[CRE/I], G0-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[CRE/I], G1-G1
0
   0.0%
1
   4.2%
1
   4.5%
0
   0.0%
[CRE/I], G2-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[CRE/I], G3-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[CRE/I], G4-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[CRE/I], GUnknown-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[CRE/I], G0-G2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[CRE/I], G1-G2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[CRE/I], G2-G2
0
   0.0%
1
   4.2%
0
   0.0%
1
   2.5%
[CRE/I], G3-G2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[CRE/I], G4-G2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[CRE/I], GUknown-G2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[GGT/I], G0-G0
10
  50.0%
17
  70.8%
14
  63.6%
30
  75.0%
[GGT/I], G1-G0
1
   5.0%
1
   4.2%
1
   4.5%
4
  10.0%
[GGT/I], G2-G0
2
  10.0%
2
   8.3%
1
   4.5%
0
   0.0%
[GGT/I], G3-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[GGT/I], G4-G0
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.5%
[GGT/I], GUnknown-G0
1
   5.0%
0
   0.0%
1
   4.5%
0
   0.0%
[GGT/I], G0-G1
2
  10.0%
1
   4.2%
1
   4.5%
1
   2.5%
[GGT/I], G1-G1
0
   0.0%
1
   4.2%
1
   4.5%
3
   7.5%
[GGT/I], G2-G1
1
   5.0%
1
   4.2%
0
   0.0%
0
   0.0%
[GGT/I], G3-G1
0
   0.0%
0
   0.0%
1
   4.5%
0
   0.0%
[GGT/I], G4-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[GGT/I], GUnknown-G1
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
[GGT/I], G0-G2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[GGT/I], G1-G2
0
   0.0%
1
   4.2%
0
   0.0%
0
   0.0%
[GGT/I], G2-G2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[GGT/I], G3-G2
1
   5.0%
0
   0.0%
2
   9.1%
0
   0.0%
[GGT/I], G4-G2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[GGT/I], GUnknown-G2
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
[GGT/I], G0-G3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[GGT/I], G1-G3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[GGT/I], G2-G3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[GGT/I], G3-G3
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.5%
[GGT/I], G4-G3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[GGT/I], GUnknown-G3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
Hide Description Laboratory abnormalities belong to hematological and biochemical parameters such as: activated partial thromboplastin time prolonged [APTTP], alanine aminotransferase increased [ALT/I], alkaline phoshatase increased [APH/I], anemia [AN], asparatate aminostransferase increased [AST/I], blood bilirubin increased [BB/I], creatinine increased [CRE/I], gamma glumatymtransferase increased [GGT/I], hemoglobin increased [Hgb/I], hypoalbuminemia [HYP], lymphocyte count decreased [LYMC/D], lymphocyte count increased [LYMC/I], neutrophil count decreased [ NEUC/D], platelet count decreased [PLA/D], white blood cell decreased [WBC/D]. Parameter grades (G0,1,2,3,4,Uknown) were compared to each baseline parameter grade (GUnknown,0,1,2,3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009 [http://evs.nci.nih.gov/ftp1/CTCAE]. This endpoint presents values for [Hgb/I] and [HYP] grading versus baseline parameter grading.
Time Frame During the entire study period - up to Year 4 + 1 month post last study treatment administration
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.
Arm/Group Title GSK2302025A Cohort 1 GSK2302025A Cohort 2 GSK2302025A Cohort 3 GSK2302025A Cohort 4
Hide Arm/Group Description:
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
Overall Number of Participants Analyzed 20 24 22 40
Measure Type: Count of Participants
Unit of Measure: Participants
[Hgb/I], G0-G0
16
  80.0%
24
 100.0%
21
  95.5%
37
  92.5%
[Hgb/I], G1-G0
0
   0.0%
0
   0.0%
0
   0.0%
2
   5.0%
[Hgb/I], G2-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[Hgb/I], G3-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[Hgb/I], G4-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[Hgb/I], GUnknown-G0
2
  10.0%
0
   0.0%
1
   4.5%
0
   0.0%
[Hgb/I], G0-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[Hgb/I], G1-G1
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
[Hgb/I], G2-G1
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.5%
[Hgb/I], G3-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[Hgb/I], G4-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[Hgb/I], GUnknown-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[Hgb/I], G0-G2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[Hgb/I], G1-G2
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
[Hgb/I], G2-G2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[Hgb/I], G3-G2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[Hgb/I], G4-G2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[Hgb/I], GUnknown-G2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[HYP], G0-G0
13
  65.0%
17
  70.8%
18
  81.8%
30
  75.0%
[HYP], G1-G0
2
  10.0%
5
  20.8%
2
   9.1%
5
  12.5%
[HYP], G2-G0
0
   0.0%
1
   4.2%
0
   0.0%
1
   2.5%
[HYP], G3-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[HYP], G4-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[HYP], GUnknown-G0
3
  15.0%
0
   0.0%
2
   9.1%
0
   0.0%
[HYP], G0-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[HYP], G1-G1
1
   5.0%
1
   4.2%
0
   0.0%
3
   7.5%
[HYP], G2-G1
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
[HYP], G3-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[HYP], G4-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[HYP], GUnknown-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[HYP], G0-G3
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.5%
[HYP], G1-G3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[HYP], G2-G3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[HYP], G3-G3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[HYP], G4-G3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[HYP], GUnknown-G3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
11.Secondary Outcome
Title Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
Hide Description Laboratory abnormalities belong to hematological and biochemical parameters such as: activated partial thromboplastin time prolonged [APTTP], alanine aminotransferase increased [ALT/I], alkaline phoshatase increased [APH/I], anemia [AN], asparatate aminostransferase increased [AST/I], blood bilirubin increased [BB/I], creatinine increased [CRE/I], gamma glumatymtransferase increased [GGT/I], hemoglobin increased [Hgb/I], hypoalbuminemia [HYP], lymphocyte count decreased [LYMC/D], lymphocyte count increased [LYMC/I], neutrophil count decreased [ NEUC/D], platelet count decreased [PLA/D], white blood cell decreased [WBC/D]. Parameter grades (G0,1,2,3,4,Uknown) were compared to each baseline parameter grade (GUnknown,0,1,2,3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009 [http://evs.nci.nih.gov/ftp1/CTCAE]. This endpoint presents values for [LYMC/D] and [LYMC/I] grading versus baseline parameter grading.
Time Frame During the entire study period - up to Year 4 + 1 month post last study treatment administration
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.
Arm/Group Title GSK2302025A Cohort 1 GSK2302025A Cohort 2 GSK2302025A Cohort 3 GSK2302025A Cohort 4
Hide Arm/Group Description:
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
Overall Number of Participants Analyzed 20 24 22 40
Measure Type: Count of Participants
Unit of Measure: Participants
[LYMC/D], G0-G0
10
  50.0%
14
  58.3%
14
  63.6%
28
  70.0%
[LYMC/D], G1-G0
3
  15.0%
4
  16.7%
3
  13.6%
4
  10.0%
[LYMC/D], G2-G0
1
   5.0%
1
   4.2%
0
   0.0%
0
   0.0%
[LYMC/D], G3-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[LYMC/D], G4-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[LYMC/D], GUnknown-G0
0
   0.0%
0
   0.0%
1
   4.5%
0
   0.0%
[LYMC/D], G0-G1
0
   0.0%
1
   4.2%
1
   4.5%
2
   5.0%
[LYMC/D], G1-G1
3
  15.0%
3
  12.5%
2
   9.1%
5
  12.5%
[LYMC/D], G2-G1
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
[LYMC/D], G3-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[LYMC/D], G4-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[LYMC/D], GUnknown-G1
1
   5.0%
1
   4.2%
0
   0.0%
0
   0.0%
[LYMC/D], G0-G2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[LYMC/D], G1-G2
0
   0.0%
0
   0.0%
1
   4.5%
0
   0.0%
[LYMC/D], G2-G2
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.5%
[LYMC/D], G3-G2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[LYMC/D], G4-G2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[LYMC/D], GUnknown-G2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[LYMC/D], G0-G3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[LYMC/D], G1-G3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[LYMC/D], G2-G3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[LYMC/D], G3-G3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[LYMC/D], G4-G3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[LYMC/D], GUnknown-G3
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
[LYMC/I], G0-G0
16
  80.0%
23
  95.8%
21
  95.5%
40
 100.0%
[LYMC/I], G1-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[LYMC/I], G2-G0
2
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
[LYMC/I], G3-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[LYMC/I], G4-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[LYMC/I], GUnknown-G0
2
  10.0%
1
   4.2%
1
   4.5%
0
   0.0%
12.Secondary Outcome
Title Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
Hide Description Laboratory abnormalities belong to hematological and biochemical parameters such as: activated partial thromboplastin time prolonged [APTTP], alanine aminotransferase increased [ALT/I], alkaline phoshatase increased [APH/I], anemia [AN], asparatate aminostransferase increased [AST/I], blood bilirubin increased [BB/I], creatinine increased [CRE/I], gamma glumatymtransferase increased [GGT/I], hemoglobin increased [Hgb/I], hypoalbuminemia [HYP], lymphocyte count decreased [LYMC/D], lymphocyte count increased [LYMC/I], neutrophil count decreased [NEUC/D], platelet count decreased [PLA/D], white blood cell decreased [WBC/D]. Parameter grades (G0,1,2,3,4,Uknown) were compared to each baseline parameter grades (GUnknown,0,1,2,3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009 [http://evs.nci.nih.gov/ftp1/CTCAE]. This endpoint presents values for [NEUC/D], [PLA/D] and [WBC/D] grading versus baseline parameter grading.
Time Frame During the entire study period - up to Year 4 + 1 month post last study treatment administration
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.
Arm/Group Title GSK2302025A Cohort 1 GSK2302025A Cohort 2 GSK2302025A Cohort 3 GSK2302025A Cohort 4
Hide Arm/Group Description:
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
Overall Number of Participants Analyzed 20 24 22 40
Measure Type: Count of Participants
Unit of Measure: Participants
[NEUC/D], G0-G0
17
  85.0%
21
  87.5%
21
  95.5%
39
  97.5%
[NEUC/D], G1-G0
1
   5.0%
2
   8.3%
0
   0.0%
0
   0.0%
[NEUC/D], G2-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[NEUC/D], G3-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[NEUC/D], G4-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[NEUC/D], GUnknown-G0
2
  10.0%
1
   4.2%
1
   4.5%
0
   0.0%
[NEUC/D], G0-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[NEUC/D], G1-G1
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.5%
[NEUC/D], G2-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[NEUC/D], G3-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[NEUC/D], G4-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[NEUC/D], GUnknown-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[PLA/D], G0-G0
17
  85.0%
24
 100.0%
20
  90.9%
38
  95.0%
[PLA/D], G1-G0
1
   5.0%
0
   0.0%
0
   0.0%
2
   5.0%
[PLA/D], G2-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[PLA/D], G3-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[PLA/D], G4-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[PLA/D], GUnknown-G0
2
  10.0%
0
   0.0%
1
   4.5%
0
   0.0%
[PLA/D], G0-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[PLA/D], G1-G1
0
   0.0%
0
   0.0%
1
   4.5%
0
   0.0%
[PLA/D], G2-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[PLA/D], G3-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[PLA/D], G4-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[PLA/D], GUnknown-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[WBC/D], G0-G0
14
  70.0%
21
  87.5%
19
  86.4%
34
  85.0%
[WBC/D], G1-G0
2
  10.0%
1
   4.2%
1
   4.5%
3
   7.5%
[WBC/D], G2-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[WBC/D], G3-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[WBC/D], G4-G0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[WBC/D], GUnknown-G0
2
  10.0%
0
   0.0%
1
   4.5%
0
   0.0%
[WBC/D], G0-G1
1
   5.0%
0
   0.0%
0
   0.0%
2
   5.0%
[WBC/D], G1-G1
1
   5.0%
2
   8.3%
1
   4.5%
1
   2.5%
[WBC/D], G2-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[WBC/D], G3-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[WBC/D], G4-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[WBC/D], GUnknown-G1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
13.Secondary Outcome
Title Percentage of Patients With Anti-PRAME Cellular (T-cell) Response (Phase I)
Hide Description Cellular response was defined as: Geometric Mean Response (GMR) above the 2.68 cut-off value and at least a four-fold increase of PRAME- specific Cluster of Differentiation (CD) 4/8 T-cells. Considering that 2 studies failed to demonstrate clinical efficacy of recombinant protein based cancer vaccines, GSK decided in 2014 to stop the development and to stop recruitment in all the ongoing clinical studies. The decision was made to end the study (i.e., stopping patient enrollment, follow-ups, sample collection and analysis of samples for research purposes). Patients still on treatment at the time of the protocol amendment were offered to continue the administration of the study treatment until the last dose or until recurrence, whichever came first, or until the patient or the investigator decided to stop the study treatment. No further active protocol visit/contact was performed except for the concluding visit at Week 199, 30 days after the last treatment administration.
Time Frame Up to Data Lock Point at Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Phase 1 subjects with available results up to Week 8, from the Total treated population, which included all enrolled patients who have received at least one study dose injection.
Arm/Group Title GSK2302025A Cohort 1 GSK2302025A Cohort 2 GSK2302025A Cohort 3
Hide Arm/Group Description:
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Overall Number of Participants Analyzed 8 11 14
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
Patients with CD4 pre+post-administration results Number Analyzed 8 participants 11 participants 14 participants
100
(63.1 to 100)
100
(71.5 to 100)
100
(76.8 to 100)
Responders CD4 Number Analyzed 8 participants 11 participants 14 participants
75.0
(34.9 to 96.8)
45.5
(16.7 to 76.6)
57.1
(28.9 to 82.3)
Patients with CD8 pre+post-administration results Number Analyzed 8 participants 9 participants 8 participants
100
(63.1 to 100)
100
(66.4 to 100)
100
(63.1 to 100)
Responders CD8 Number Analyzed 8 participants 9 participants 8 participants
0.0
(0.0 to 36.9)
0.0
(0.0 to 33.6)
0.0
(0.0 to 36.9)
14.Secondary Outcome
Title Number of Patients With Anti-PRAME Humoral Immune Response (Phase I & II)
Hide Description A seropositive patient was a patient whose anti-PRAME antibody concentration was greater than or equal to (≥) the assay cut-off value of 12 ELISA units per milliliter (EL.U/mL). A seronegative patient was defined as a patient whose pre-treatment antibody concentration was below (<) the cut-off value. An anti-PRAME antibody responder was defined as: For a seronegative patient: a post-treatment antibody concentration ≥ the cut-off value; For a seropositive patient: a post-treatment antibody concentration ≥ twice the pre-treatment antibody concentration.
Time Frame At Weeks 0, 4, 8, 10, 12, 29, 51, 75, 99, 123, 147 and conclusion visit at 30 days post last treatment administration (Week 199) for each patient
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.
Arm/Group Title GSK2302025A Cohort 1 GSK2302025A Cohort 2 GSK2302025A Cohort 3 GSK2302025A Cohort 4
Hide Arm/Group Description:
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
Overall Number of Participants Analyzed 20 24 22 40
Measure Type: Count of Participants
Unit of Measure: Participants
anti-PRAME,Week 0 Number Analyzed 20 participants 24 participants 22 participants 40 participants
0
   0.0%
0
   0.0%
0
   0.0%
2
   5.0%
anti-PRAME, Week 4 Number Analyzed 15 participants 18 participants 21 participants 36 participants
11
  73.3%
14
  77.8%
18
  85.7%
33
  91.7%
anti-PRAME, Week 8 Number Analyzed 14 participants 13 participants 21 participants 33 participants
14
 100.0%
13
 100.0%
21
 100.0%
33
 100.0%
anti-PRAME, Week 10 Number Analyzed 10 participants 12 participants 19 participants 33 participants
10
 100.0%
12
 100.0%
19
 100.0%
33
 100.0%
anti-PRAME, Week 12 Number Analyzed 9 participants 9 participants 16 participants 28 participants
9
 100.0%
9
 100.0%
16
 100.0%
28
 100.0%
anti-PRAME, Week 29 Number Analyzed 2 participants 4 participants 5 participants 13 participants
2
 100.0%
4
 100.0%
5
 100.0%
13
 100.0%
anti-PRAME, Week 51 Number Analyzed 1 participants 3 participants 3 participants 7 participants
1
 100.0%
3
 100.0%
3
 100.0%
7
 100.0%
anti-PRAME, Week 75 Number Analyzed 2 participants 2 participants 2 participants 1 participants
2
 100.0%
2
 100.0%
2
 100.0%
1
 100.0%
anti-PRAME, Week 99 Number Analyzed 2 participants 2 participants 2 participants 0 participants
2
 100.0%
2
 100.0%
2
 100.0%
0
anti-PRAME, Week 123 Number Analyzed 1 participants 1 participants 1 participants 0 participants
1
 100.0%
1
 100.0%
1
 100.0%
0
anti-PRAME, Week 147 Number Analyzed 1 participants 0 participants 0 participants 0 participants
1
 100.0%
0 0 0
anti-PRAME, Week 199 Number Analyzed 6 participants 12 participants 8 participants 23 participants
6
 100.0%
12
 100.0%
8
 100.0%
23
 100.0%
15.Secondary Outcome
Title Number of Patients With Stable Disease (SD), Progressive Disease (PD), Mixed Response (MR) (Phase I & II)
Hide Description Tumor response was assessed by the Response Evaluation Criteria In Solid Tumors (RECIST), where stable disease for target lesions refers to neither enough shrinkage to qualify for complete response nor sufficient increase to qualify for progressive disease taking as references the smallest sum longest diameter (LD) since the treatment started. For non-targeted lesions it refers to persistence of one or more non-target lesions. Progressive disease is related to a clear increase of diameters of lesions taking as references the smallest diameters recorded since the treatment started OR the appearance of one or more new lesions OR both of these.
Time Frame At 30 days after the last treatment administration for each patient (Week 199)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all enrolled patients who have received at least one study dose injection.
Arm/Group Title GSK2302025A Cohort 1 GSK2302025A Cohort 2 GSK2302025A Cohort 3 GSK2302025A Cohort 4
Hide Arm/Group Description:
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
Overall Number of Participants Analyzed 20 24 22 40
Measure Type: Count of Participants
Unit of Measure: Participants
Complete response
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Partial response
0
   0.0%
0
   0.0%
0
   0.0%
4
  10.0%
Stable disease
2
  10.0%
1
   4.2%
1
   4.5%
1
   2.5%
Stable Disease/Progressive disease
0
   0.0%
1
   4.2%
1
   4.5%
3
   7.5%
Progressive disease
9
  45.0%
18
  75.0%
15
  68.2%
31
  77.5%
Non Evaluable
2
  10.0%
1
   4.2%
0
   0.0%
1
   2.5%
Missing Best overall response
7
  35.0%
3
  12.5%
5
  22.7%
0
   0.0%
Disease control: Yes
2
  10.0%
2
   8.3%
2
   9.1%
8
  20.0%
Disease control: No
18
  90.0%
22
  91.7%
20
  90.9%
32
  80.0%
16.Secondary Outcome
Title Number of Patients With Best Overall Response, Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria (Phase I & II)
Hide Description Tumor response was assessed by the RECIST criteria, where SD for target lesions refers to neither enough shrinkage to qualify for CR nor sufficient increase to qualify for PD taking as references the smallest sum longest diameter (LD) since the treatment started. For non-targeted lesions it refers to persistence of one or more nom-target lesions. Progressive disease is related to a clear increase of diameters of lesions taking as references the smallest diameters recorded since the treatment started OR the appearance of one or more new lesions OR both of these. Mixed response is defined as at least 30% decrease in the LD occurring in at least one target lesion recorded and measured at baseline. Such response occurring in otherwise SD or PD status of the LD of target lesions were classified as "SD with target lesion regression" or "PD with target lesion regression", respectively. New lesion(s) in otherwise PR status of the LD of target lesions were "PR with new lesion".
Time Frame At 30 days after the last treatment administration for each patient (Week 199)
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Hide Analysis Population Description
The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.
Arm/Group Title GSK2302025A Cohort 1 GSK2302025A Cohort 2 GSK2302025A Cohort 3 GSK2302025A Cohort 4
Hide Arm/Group Description:
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
Overall Number of Participants Analyzed 20 24 22 40
Measure Type: Count of Participants
Unit of Measure: Participants
PR
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
CR
0
   0.0%
0
   0.0%
0
   0.0%
4
  10.0%
MxR: SD with target lesion regression
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
MxR: PD with target lesion regression
2
  10.0%
2
   8.3%
2
   9.1%
3
   7.5%
MxR: PR with new lesion
0
   0.0%
0
   0.0%
1
   4.5%
0
   0.0%
SD/PR
0
   0.0%
1
   4.2%
1
   4.5%
3
   7.5%
SD without mixed response
2
  10.0%
0
   0.0%
1
   4.5%
1
   2.5%
PD with SPD criteria
3
  15.0%
5
  20.8%
4
  18.2%
19
  47.5%
PD without SPD/MxR
4
  20.0%
12
  50.0%
8
  36.4%
9
  22.5%
Non Evaluable
2
  10.0%
1
   4.2%
0
   0.0%
1
   2.5%
Missing Best overall response
7
  35.0%
3
  12.5%
5
  22.7%
0
   0.0%
17.Secondary Outcome
Title Anti-Protein D Humoral Response (Phase I & II)
Hide Description Analysis of immunogenicity for anti-PD antibodies was not performed, following negative results to the NCT00480025 study which assessed another study product from same technology platform. For this study, the main analysis of the dose-escalation Phase I segment was performed according to protocol when all patients enrolled in the Phase I segment had received the first 4 treatment doses and had completed Week 8. The main analysis of the Phase II segment was performed according to protocol when all patients had either completed the treatment until the end of Cycle 3 or had been withdrawn from the study treatment, with the exception of anti-PD antibody responses and PRAME-specific cellular responses which were not yet performed. All samples that had been collected but not yet tested were not tested by default, except if a scientific rationale remained relevant.
Time Frame At Week 0, 4, 8, 12, 29, 51, 75, 99, 123, 147, 30 days after the last treatment administration for each patient (Week 199), with follow-up, 3, 6, 9 and 12 months after concluding visit
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Hide Analysis Population Description
This analysis was not performed.
Arm/Group Title GSK2302025A Cohort 1 GSK2302025A Cohort 2 GSK2302025A Cohort 3 GSK2302025A Cohort 4
Hide Arm/Group Description:
Subjects will receive investigational dose-level A (different from dose-levels B and C). Patients will receive a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic
Subjects will receive investigational dose-level B (different from dose-levels A and C). Patients will receive a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic
Subjects will receive investigational dose-level C (different from dose-levels A and B). Patients will receive a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic
In Phase 2 of the study subjects will receive the optimal investigational dose-level identified in Phase 1. Patients will receive a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Secondary Outcome
Title Anti-Cytosine Phosphate Guanosine Oligodeoxynucleotide (CpG) Humoral Response (Phase I & II)
Hide Description Analysis of immunogenicity for anti-CpG antibodies was not performed, following negative results to the NCT00480025 study which assessed another study product from same technology platform. For this study, the main analysis of the dose-escalation Phase I segment was performed according to protocol when all patients enrolled in the Phase I segment had received the first 4 treatment doses and had completed Week 8. The main analysis of the Phase II segment was performed according to protocol when all patients had either completed the treatment until the end of Cycle 3 or had been withdrawn from the study treatment, with the exception of anti-CpG antibody responses and PRAME-specific cellular responses which were not yet performed. All samples that had been collected but not yet tested were not tested by default, except if a scientific rationale remained relevant.
Time Frame At Week 0, 4, 8, 12, 29, 51, 75, 99, 123, 147, 30 days after the last treatment administration for each patient (Week 199), with follow-up, 3, 6, 9 and 12 months after concluding visit
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Hide Analysis Population Description
This analysis was not performed.
Arm/Group Title GSK2302025A Cohort 1 GSK2302025A Cohort 2 GSK2302025A Cohort 3 GSK2302025A Cohort 4
Hide Arm/Group Description:
Subjects will receive investigational dose-level A (different from dose-levels B and C). Patients will receive a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic
Subjects will receive investigational dose-level B (different from dose-levels A and C). Patients will receive a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic
Subjects will receive investigational dose-level C (different from dose-levels A and B). Patients will receive a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic
In Phase 2 of the study subjects will receive the optimal investigational dose-level identified in Phase 1. Patients will receive a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
19.Secondary Outcome
Title Time to Treatment Failure, Progression Free Survival and Overall Survival (Phase I & II)
Hide Description Time to treatment failure (TTF) was defined as the time from first administration of study product until the date of the last administration of the product, irrespective of the reason for study treatment discontinuation. Progression-free survival (PFS) was defined as the time from first adminsitration of study product until the date of either disease progression or death (for whatever reason), whichever comes first. Overall survival (OS) was defined as the time from first administration of study product until death.
Time Frame Up to concluding visit, at Week 199
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.
Arm/Group Title GSK2302025A Cohort 1 GSK2302025A Cohort 2 GSK2302025A Cohort 3 GSK2302025A Cohort 4
Hide Arm/Group Description:
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
Overall Number of Participants Analyzed 20 24 22 40
Median (95% Confidence Interval)
Unit of Measure: Months
TTF
2.3
(1.0 to 4.9)
2.3
(1.3 to 4.2)
3.0
(2.3 to 4.9)
4.6
(2.7 to 5.3)
PFS
2.7
(1.4 to 2.9)
2.7
(1.0 to 2.8)
2.8
(2.1 to 2.9)
2.8
(2.7 to 3.3)
OS
17.0 [1] 
(8.1 to NA)
11.5 [1] 
(7.3 to NA)
10.8
(8.4 to 25.5)
23.0 [1] 
(15.5 to NA)
[1]
The upper limit of the 95% confidence interval for this group was below the limit of detection.
20.Secondary Outcome
Title Duration of Response for Patients With CR, PR and SD or SD/PR Status (Phase II)
Hide Description This analysis was not performed following negative results to the NCT00480025 study which assessed another study product from same technology platform. For this study, the main analysis of the dose-escalation Phase I segment was performed according to protocol when all patients enrolled in the Phase I segment had received the first 4 treatment doses and had completed Week 8. The main analysis of the Phase II segment was performed according to protocol when all patients had either completed the treatment until the end of Cycle 3 or had been withdrawn from the study treatment, with the exception of anti-CpG/anti-PD antibody responses and PRAME-specific cellular responses which were not yet performed. All samples that had been collected but not yet tested were not tested by default, except if a scientific rationale remained relevant.
Time Frame Up to concluding visit, at Week 199
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was not performed.
Arm/Group Title GSK2302025A Cohort 1 GSK2302025A Cohort 2 GSK2302025A Cohort 3 GSK2302025A Cohort 4
Hide Arm/Group Description:
Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4.
In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Unsolicited AEs and serious adverse events (SAEs): from study start (Day 0) up to the concluding visit, at Month 49 (Week 199).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GSK2302025A Cohort 1 GSK2302025A Cohort 2 GSK2302025A Cohort 3 GSK2302025A Cohort 4
Hide Arm/Group Description Male or female patients with histologically proven cutaneous melanoma received the investigational Low-Dose (LD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4. Male or female patients with histologically proven cutaneous melanoma received the investigational Middle-Dose (MD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4. Male or female patients with histologically proven cutaneous melanoma received the investigational High-Dose (HD) adjuvanted GSK2302025A immunotherapeutic vaccine, intramuscularly into the deltoid or lateral region of the thigh, with alternation on right or left side at each succeeding injection. Subjects received a total of 24 administrations in 4 cycles: 6 administrations given at 2 weeks intervals in cycle 1, 6 administrations given at 3 weeks intervals in cycle 2, 4 administrations given at 6 weeks intervals in cycle 3 and 4 administrations given at 3 months interval in cycle 4. In Phase 2 of the study subjects received the optimal investigational dose-level identified in Phase 1. Patients received a treatment consisting of 24 injections of the experimental GSK2302025A immunotherapeutic.
All-Cause Mortality
GSK2302025A Cohort 1 GSK2302025A Cohort 2 GSK2302025A Cohort 3 GSK2302025A Cohort 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      0/24 (0.00%)      0/22 (0.00%)      2/40 (5.00%)    
Hide Serious Adverse Events
GSK2302025A Cohort 1 GSK2302025A Cohort 2 GSK2302025A Cohort 3 GSK2302025A Cohort 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/20 (15.00%)      3/24 (12.50%)      2/22 (9.09%)      5/40 (12.50%)    
Cardiac disorders         
Atrial fibrillation  1  1/20 (5.00%)  1 0/24 (0.00%)  0 0/22 (0.00%)  0 0/40 (0.00%)  0
Gastrointestinal disorders         
Intestinal obstruction  1  0/20 (0.00%)  0 0/24 (0.00%)  0 1/22 (4.55%)  1 0/40 (0.00%)  0
General disorders         
Fatigue  1  1/20 (5.00%)  1 0/24 (0.00%)  0 0/22 (0.00%)  0 0/40 (0.00%)  0
Pain  1  1/20 (5.00%)  1 0/24 (0.00%)  0 0/22 (0.00%)  0 0/40 (0.00%)  0
Hepatobiliary disorders         
Cholestasis  1  0/20 (0.00%)  0 0/24 (0.00%)  0 0/22 (0.00%)  0 1/40 (2.50%)  1
Infections and infestations         
Erysipelas  1  1/20 (5.00%)  1 0/24 (0.00%)  0 0/22 (0.00%)  0 0/40 (0.00%)  0
Infected skin ulcer  1  1/20 (5.00%)  1 0/24 (0.00%)  0 0/22 (0.00%)  0 0/40 (0.00%)  0
Pneumonia  1  0/20 (0.00%)  0 0/24 (0.00%)  0 0/22 (0.00%)  0 1/40 (2.50%)  1
Subcutaneous abscess  1  0/20 (0.00%)  0 1/24 (4.17%)  1 0/22 (0.00%)  0 0/40 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Bursitis  1  1/20 (5.00%)  1 0/24 (0.00%)  0 0/22 (0.00%)  0 0/40 (0.00%)  0
Osteoarthritis  1  0/20 (0.00%)  0 1/24 (4.17%)  1 0/22 (0.00%)  0 0/40 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Renal neoplasm  1  0/20 (0.00%)  0 0/24 (0.00%)  0 0/22 (0.00%)  0 1/40 (2.50%)  1
Nervous system disorders         
Brain oedema  1  0/20 (0.00%)  0 1/24 (4.17%)  1 0/22 (0.00%)  0 0/40 (0.00%)  0
Sciatica  1  1/20 (5.00%)  1 0/24 (0.00%)  0 0/22 (0.00%)  0 0/40 (0.00%)  0
Renal and urinary disorders         
Haematuria  1  0/20 (0.00%)  0 0/24 (0.00%)  0 1/22 (4.55%)  1 0/40 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease  1  0/20 (0.00%)  0 0/24 (0.00%)  0 0/22 (0.00%)  0 1/40 (2.50%)  1
Pneumothorax  1  0/20 (0.00%)  0 0/24 (0.00%)  0 1/22 (4.55%)  1 0/40 (0.00%)  0
Pulmonary embolism  1  0/20 (0.00%)  0 0/24 (0.00%)  0 0/22 (0.00%)  0 1/40 (2.50%)  1
Skin and subcutaneous tissue disorders         
Skin ulcer  1  1/20 (5.00%)  1 0/24 (0.00%)  0 0/22 (0.00%)  0 0/40 (0.00%)  0
Vascular disorders         
Circulatory collapse  1  0/20 (0.00%)  0 0/24 (0.00%)  0 0/22 (0.00%)  0 1/40 (2.50%)  1
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
GSK2302025A Cohort 1 GSK2302025A Cohort 2 GSK2302025A Cohort 3 GSK2302025A Cohort 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/20 (100.00%)      21/24 (87.50%)      21/22 (95.45%)      39/40 (97.50%)    
Blood and lymphatic system disorders         
Anaemia  1  0/20 (0.00%)  0 3/24 (12.50%)  3 0/22 (0.00%)  0 1/40 (2.50%)  1
Leukopenia  1  1/20 (5.00%)  1 1/24 (4.17%)  1 0/22 (0.00%)  0 0/40 (0.00%)  0
Lymph node pain  1  1/20 (5.00%)  1 0/24 (0.00%)  0 0/22 (0.00%)  0 0/40 (0.00%)  0
Neutropenia  1  1/20 (5.00%)  1 0/24 (0.00%)  0 0/22 (0.00%)  0 0/40 (0.00%)  0
Cardiac disorders         
Supraventricular tachycardia  1  1/20 (5.00%)  1 0/24 (0.00%)  0 0/22 (0.00%)  0 0/40 (0.00%)  0
Nodal arrhythmia  1  0/20 (0.00%)  0 1/24 (4.17%)  1 0/22 (0.00%)  0 0/40 (0.00%)  0
Atrioventricular block  1  0/20 (0.00%)  0 0/24 (0.00%)  0 0/22 (0.00%)  0 1/40 (2.50%)  1
Palpitations  1  0/20 (0.00%)  0 0/24 (0.00%)  0 0/22 (0.00%)  0 1/40 (2.50%)  1
Tachycardia  1  0/20 (0.00%)  0 0/24 (0.00%)  0 0/22 (0.00%)  0 1/40 (2.50%)  1
Ear and labyrinth disorders         
Tinnitus  1  1/20 (5.00%)  1 0/24 (0.00%)  0 0/22 (0.00%)  0 0/40 (0.00%)  0
Vertigo  1  0/20 (0.00%)  0 1/24 (4.17%)  1 0/22 (0.00%)  0 0/40 (0.00%)  0
Ear haemorrhage  1  0/20 (0.00%)  0 0/24 (0.00%)  0 1/22 (4.55%)  1 0/40 (0.00%)  0
Ear pain  1  0/20 (0.00%)  0 0/24 (0.00%)  0 0/22 (0.00%)  0 1/40 (2.50%)  1
Hypoacusis  1  0/20 (0.00%)  0 0/24 (0.00%)  0 0/22 (0.00%)  0 1/40 (2.50%)  1
Endocrine disorders         
Glucocorticoid deficiency  1  0/20 (0.00%)  0 0/24 (0.00%)  0 0/22 (0.00%)  0 2/40 (5.00%)  2
Adrenal insufficiency  1  0/20 (0.00%)  0 0/24 (0.00%)  0 1/22 (4.55%)  1 0/40 (0.00%)  0
Eye disorders         
Conjunctivitis  1  0/20 (0.00%)  0 0/24 (0.00%)  0 0/22 (0.00%)  0 1/40 (2.50%)  1
Conjunctivitis allergic  1  0/20 (0.00%)  0 0/24 (0.00%)  0 0/22 (0.00%)  0 1/40 (2.50%)  1
Eyelid oedema  1  0/20 (0.00%)  0 0/24 (0.00%)  0 0/22 (0.00%)  0 1/40 (2.50%)  1
Gastrointestinal disorders         
Abdominal discomfort  1  1/20 (5.00%)  1 1/24 (4.17%)  1 0/22 (0.00%)  0 0/40 (0.00%)  0
Abdominal pain  1  1/20 (5.00%)  1 0/24 (0.00%)  0 2/22 (9.09%)  4 3/40 (7.50%)  3
Abdominal pain upper  1  0/20 (0.00%)  0 0/24 (0.00%)  0 2/22 (9.09%)  2 1/40 (2.50%)  1
Constipation  1  1/20 (5.00%)  1 2/24 (8.33%)  2 2/22 (9.09%)  2 3/40 (7.50%)  3
Diarrhoea  1  1/20 (5.00%)  2 1/24 (4.17%)  1 1/22 (4.55%)  1 5/40 (12.50%)  7
Dry mouth  1  1/20 (5.00%)  1 0/24 (0.00%)  0 0/22 (0.00%)  0 0/40 (0.00%)  0
Nausea  1  5/20 (25.00%)  5 4/24 (16.67%)  8 2/22 (9.09%)  2 11/40 (27.50%)  14
Vomiting  1  2/20 (10.00%)  2 4/24 (16.67%)  8 0/22 (0.00%)  0 5/40 (12.50%)  5
Atrial fibrillation  1  1/20 (5.00%)  1 0/24 (0.00%)  0 0/22 (0.00%)  0 0/40 (0.00%)  0
Bursitis  1  1/20 (5.00%)  1 0/24 (0.00%)  0 0/22 (0.00%)  0 0/40 (0.00%)  0
Dysphagia  1  0/20 (0.00%)  0 1/24 (4.17%)  1 0/22 (0.00%)  0 0/40 (0.00%)  0
Flatulence  1  0/20 (0.00%)  0 1/24 (4.17%)  1 0/22 (0.00%)  0 0/40 (0.00%)  0
Abdominal distension  1  0/20 (0.00%)  0 0/24 (0.00%)  0 1/22 (4.55%)  1 1/40 (2.50%)  1
Gastrooesophageal reflux disease  1  0/20 (0.00%)  0 0/24 (0.00%)  0 1/22 (4.55%)  1 0/40 (0.00%)  0
Intestinal obstruction  1  0/20 (0.00%)  0 0/24 (0.00%)  0 1/22 (4.55%)  1 0/40 (0.00%)  0
Dental caries  1  0/20 (0.00%)  0 0/24 (0.00%)  0 0/22 (0.00%)  0 1/40 (2.50%)  1
Gastrointestinal motility disorder  1  0/20 (0.00%)  0 0/24 (0.00%)  0 0/22 (0.00%)  0 1/40 (2.50%)  1
Odynophagia  1  0/20 (0.00%)  0 0/24 (0.00%)  0 0/22 (0.00%)  0 1/40 (2.50%)  1
Oesophagitis  1  0/20 (0.00%)  0 0/24 (0.00%)  0 0/22 (0.00%)  0 1/40 (2.50%)  1
General disorders         
Administration site pain  1  0/20 (0.00%)  0 1/24 (4.17%)  2 1/22 (4.55%)  2 2/40 (5.00%)  4
Asthenia  1  2/20 (10.00%)  2 0/24 (0.00%)  0 6/22 (27.27%)  21 13/40 (32.50%)  32
Chest discomfort  1  1/20 (5.00%)  6 0/24 (0.00%)  0 0/22 (0.00%)  0 0/40 (0.00%)  0
Chills  1  4/20 (20.00%)  10 1/24 (4.17%)  2 4/22 (18.18%)  14 8/40 (20.00%)  14
Fatigue  1  5/20 (25.00%)  10 7/24 (29.17%)  36 6/22 (27.27%)  10 7/40 (17.50%)  12
Feeling cold  1  1/20 (5.00%)  2 0/24 (0.00%)  0 0/22 (0.00%)  0 0/40 (0.00%)  0
Hyperplasia  1  1/20 (5.00%)  1 0/24 (0.00%)  0 0/22 (0.00%)  0 0/40 (0.00%)  0
Hyperthermia  1  1/20 (5.00%)  1 0/24 (0.00%)  0 1/22 (4.55%)  1 0/40 (0.00%)  0
Inflammation  1  1/20 (5.00%)  1 0/24 (0.00%)  0 0/22 (0.00%)  0 1/40 (2.50%)  1
Influenza like illness  1  4/20 (20.00%)  18 6/24 (25.00%)  11 7/22 (31.82%)  16 13/40 (32.50%)  29
Injection site erythema  1  3/20 (15.00%)  13 7/24 (29.17%)  17 7/22 (31.82%)  14 8/40 (20.00%)  18
Injection site oedema  1  0/20 (0.00%)  0 1/24 (4.17%)  3 2/22 (9.09%)  4 1/40 (2.50%)  1
Injection site pain  1  9/20 (45.00%)  39 10/24 (41.67%)  32 12/22 (54.55%)  51 24/40 (60.00%)  90
Injection site pruritus  1  2/20 (10.00%)  2 2/24 (8.33%)  2 1/22 (4.55%)  8 0/40 (0.00%)  0
Injection site reaction  1  5/20 (25.00%)  6 4/24 (16.67%)  8 2/22 (9.09%)  5 2/40 (5.00%)  3
Injection site swelling  1  0/20 (0.00%)  0 1/24 (4.17%)  4 2/22 (9.09%)  4 0/40 (0.00%)  0
Malaise  1  1/20 (5.00%)  2 1/24 (4.17%)  1 0/22 (0.00%)  0 1/40 (2.50%)  3
Oedema  1  0/20 (0.00%)  0 0/24 (0.00%)  0 2/22 (9.09%)  3 0/40 (0.00%)  0
Pain  1  3/20 (15.00%)  3 0/24 (0.00%)  0 3/22 (13.64%)  4 8/40 (20.00%)  9
Pyrexia  1  6/20 (30.00%)  20 8/24 (33.33%)  22 5/22 (22.73%)  8 22/40 (55.00%)  86
Swelling  1  0/20 (0.00%)  0 0/24 (0.00%)  0 0/22 (0.00%)  0 2/40 (5.00%)  4
Erysipelas  1  1/20 (5.00%)  1 0/24 (0.00%)  0 0/22 (0.00%)  0 0/40 (0.00%)  0
Axillary pain  1  0/20 (0.00%)  0 1/24 (4.17%)  1 0/22 (0.00%)  0 0/40 (0.00%)  0
Injection site discomfort  1  0/20 (0.00%)  0 1/24 (4.17%)  1 0/22 (0.00%)  0 0/40 (0.00%)  0
Injection site inflammation  1  0/20 (0.00%)  0 1/24 (4.17%)  1 0/22 (0.00%)  0 0/40 (0.00%)  0
Oedema peripheral  1  0/20 (0.00%)  0 1/24 (4.17%)  1 1/22 (4.55%)  1 1/40 (2.50%)  1
Administration site induration  1  0/20 (0.00%)  0 0/24 (0.00%)  0 1/22 (4.55%)  1 0/40 (0.00%)  0
Injection site induration  1  0/20 (0.00%)  0 0/24 (0.00%)  0 1/22 (4.55%)  1 0/40 (0.00%)  0
Xerosis  1  0/20 (0.00%)  0 0/24 (0.00%)  0 1/22 (4.55%)  1 0/40 (0.00%)  0
Feeling hot  1  0/20 (0.00%)  0 0/24 (0.00%)  0 0/22 (0.00%)  0 1/40 (2.50%)  1
Gait disturbance  1  0/20 (0.00%)  0 0/24 (0.00%)  0 0/22 (0.00%)  0 1/40 (2.50%)  1
Peripheral swelling  1  0/20 (0.00%)  0 0/24 (0.00%)  0 0/22 (0.00%)  0 1/40 (2.50%)  1
Hepatobiliary disorders         
Cholestasis  1  0/20 (0.00%)  0 0/24 (0.00%)  0 0/22 (0.00%)  0 1/40 (2.50%)  1
Hepatocellular injury  1  0/20 (0.00%)  0 0/24 (0.00%)  0 0/22 (0.00%)  0 1/40 (2.50%)  1
Immune system disorders         
Hypersensitivity  1  0/20 (0.00%)  0 1/24 (4.17%)  1 0/22 (0.00%)  0 0/40 (0.00%)  0
Hypersensitivity  1  0/20 (0.00%)  0 0/24 (0.00%)  0 0/22 (0.00%)  0 1/40 (2.50%)  1
Infections and infestations         
Bacteriuria  1  1/20 (5.00%)  1 0/24 (0.00%)  0 0/22 (0.00%)  0 0/40 (0.00%)  0
Bronchitis  1  0/20 (0.00%)  0 0/24 (0.00%)  0 0/22 (0.00%)  0 3/40 (7.50%)  3
Cystitis  1  0/20 (0.00%)  0 0/24 (0.00%)  0 0/22 (0.00%)  0 2/40 (5.00%)  2
Infection  1  1/20 (5.00%)  1 0/24 (0.00%)  0 0/22 (0.00%)  0 0/40 (0.00%)  0
Influenza  1  2/20 (10.00%)  3 0/24 (0.00%)  0 0/22 (0.00%)  0 1/40 (2.50%)  1
Rhinitis  1  1/20 (5.00%)  1 1/24 (4.17%)  1 0/22 (0.00%)  0 4/40 (10.00%)  4
Tinea infection  1  1/20 (5.00%)  1 0/24 (0.00%)  0 0/22 (0.00%)  0 0/40 (0.00%)  0
Upper respiratory tract infection  1  1/20 (5.00%)  1 0/24 (0.00%)  0 1/22 (4.55%)  1 1/40 (2.50%)  1
Infected skin ulcer  1  1/20 (5.00%)  1 0/24 (0.00%)  0 0/22 (0.00%)  0 0/40 (0.00%)  0
Bacterial infection  1  0/20 (0.00%)  0 1/24 (4.17%)  1 0/22 (0.00%)  0 0/40 (0.00%)  0
Skin infection  1  0/20 (0.00%)  0 1/24 (4.17%)  1 0/22 (0.00%)  0 0/40 (0.00%)  0
Subcutaneous abscess  1  0/20 (0.00%)  0 1/24 (4.17%)  1 0/22 (0.00%)  0 0/40 (0.00%)  0
Urinary tract infection  1  0/20 (0.00%)  0 1/24 (4.17%)  1 0/22 (0.00%)  0 1/40 (2.50%)  1
Viral upper respiratory tract infection  1  0/20 (0.00%)  0 1/24 (4.17%)  1 0/22 (0.00%)  0 1/40 (2.50%)  1
Periodontitis  1