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A Phase III Study to Test the Benefit of a New Kind of Anti-cancer Treatment in Patients With Melanoma, After Surgical Removal of Their Tumor

Primary Purpose

Melanoma

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
GSK 2132231A
Placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring DERMA, Tumor antigen, Immunotherapeutic, Adjuvant cancer therapy, Melanoma, ASCI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Written informed consent signed.
  • Male or female patient with histologically proven stage IIIB or IIIC cutaneous melanoma presenting with macroscopic lymph node involvement suitable for surgery.
  • The patient must have been surgically rendered free of disease before the randomization.
  • Patient is ≥ 18 years old at the time of signing the informed consent form.
  • The patient's lymph node tumor shows expression of the MAGE-A3 gene.
  • The patient has fully recovered from surgery.
  • ECOG performance status of 0 or 1 at the time of randomization.
  • The patient must have adequate organ functions as assessed by standard laboratory criteria.
  • If the patient is female, she must be of non-childbearing potential, or practice adequate contraception.
  • In the opinion of the investigator, the patient can and will comply with all the requirements of the protocol.

Exclusion Criteria:

  • The patient suffers from a mucosal or ocular melanoma.
  • The patient has or has had any history of in-transit metastases
  • The patient has been treated or is scheduled to be treated with an adjuvant anticancer therapy after the surgery that qualifies the patient for inclusion in the present trial.
  • The patient requires concomitant chronic treatment with systemic corticosteroids or any other immunosuppressive agents.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study treatment.
  • The patient has a history of autoimmune disease.
  • The patient has a family history of congenital or hereditary immunodeficiency.
  • The patient is known to be positive for Human Immunodeficiency Virus (HIV) or has another confirmed or suspected immunosuppressive or immunodeficient condition.
  • History of allergic disease or reactions likely to be exacerbated by any component of the treatments.
  • The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures.
  • The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
  • The patient has previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.
  • The patient has an uncontrolled bleeding disorder.
  • For female patients: the patient is pregnant or lactating.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MAGE-A3 Group

Placebo Group

Arm Description

Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.

Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.

Outcomes

Primary Outcome Measures

Disease Free Survival (DFS)
DFS = time to event from randomization to the date of first disease recurrence (as assessed by investigator) or the date of death (whatever cause), whichever occurred first. DFS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of a recurrence/death. Types of recurrence to be considered as an event included loco-regional and distant metastases. Any death occurring without prior documentation of tumor recurrence was considered as an event (not censored in the stat. analysis) as this approach was less prone to introduce bias. If no event occurred by the time of analysis, then the time to event was censored at the last assessment date (tumor assessment/visit) of the patient. Any new primary cancer at another site, including second primary melanoma, was not considered as a recurrence and had to be reported as a Serious Adverse Event (SAE).
Disease Free Survival (DFS)
DFS = time to event from randomization to the date of first disease recurrence (as assessed by investigator) or the date of death (whatever cause), whichever occurred first. DFS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of a recurrence/death. Types of recurrence to be considered as an event included loco-regional and distant metastases. Any death occurring without prior documentation of tumor recurrence was considered as an event (not censored in the stat. analysis) as this approach was less prone to introduce bias. If no event occurred by the time of analysis, then the time to event was censored at the last assessment date (tumor assessment/visit) of the patient. Any new primary cancer at another site, including second primary melanoma, was not considered as a recurrence and had to be reported as a Serious Adverse Event (SAE).

Secondary Outcome Measures

Overall Survival (OS)
Overall Survival (OS) was defined as the time to event from randomization to the date of death, irrespective of the cause of death. OS was expressed as the person-year rate i.e. the number of patients with death (n) over the sum of the follow-up periods in years (T). Patients alive at the time of the analysis were censored on the date last known to be alive.
Disease-free Specific Survival (DFSS)
Disease Free Specific Survival (DFSS) was defined as the time to event from randomization to the date of first recurrence of disease or date of death due to melanoma (cause as assessed by investigator), whichever occurred first. DFSS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of a recurrence/death. Patients who died due to a cause other than the disease under study and patients alive at the time of analysis were censored on the date of last assessment (visit or tumor assessment).
Distant Metastasis-free Survival (DMFS)
Distant Metastasis Free Survival (DMFS) was defined as the time to event from randomization to the date of first distant metastasis or date of death, whichever occurred first. DMFS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of distant metastasis/death. Patients alive and without distant metastases were censored at the date of last assessment (visit or tumor assessment, or date of last tumor assessment as documented during the yearly contact follow-up period).
Health-related Quality of Life
The assessment of health-related quality of life was restricted to patients who consented to study participation after Protocol Amendment 1 became effective at their study site, and for whom a validated version of the Euro Quality of Life-5D (EQ-5D) questionnaire was available in their native language. The EQ-5D comprises a 5-dimensional descriptive system (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), where each item has 3 levels and together they define 243 possible health states. For each health state, a value (utility) was determined by using an additive algorithm. These utility scores were calculated for each patient at each timepoint at which an EQ-5D questionnaire was completed. The score had a maximum value of 1.0 corresponding to full health level, while lower scores, down to a minimum value of 0.0 reflected degradation in the health-related quality of life.
Number of Subjects With Anti-MAGE-A3 Antibody Concentrations Above the Cut-off Value
The cut-off value was 27 Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL).
Anti-MAGE-A3 Antibody Geometric Mean Concentrations
Anti-MAGE-A3 antibody concentrations were presented as geometric mean concentrations (GMC) and expressed in EL.U/mL.
Number of Subjects With Anti-MAGE-A3 Antibody Response
Treatment response defined as: - For initially seronegative patients: post-treatment antibody concentration ≥ 27 EL.U/mL; - For initially seropositive patients: post-treatment antibody concentration ≥ 2 fold the pre-treatment antibody concentration.
Number of Subjects With Abnormal Haematological and Biochemical Parameters
Laboratory abnormalities belong to hematological and biochemical parameters such as: alanine aminotransferase [ALT], asparatate aminostransferase [AST], alkaline phoshatase [AP], bilirubin [BIL], creatinine [CREA], hemoglobin [HGB], leukocytes [LEU], lymphopenia [LYMPH], neutrophils [NEU], platelets [PLA]. Parameter grades (Grade [G] 0, 1, 2, 3, 4, Unknown) were compared to each baseline parameter grade (G Unknown, 0, 1, 2, 3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 of August 9, 2006.
Number of Subjects With Any Adverse Events (AEs)
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.
Number of Subjects With Any Serious Adverse Events (SAEs)
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.
Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

Full Information

First Posted
November 21, 2008
Last Updated
February 5, 2021
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00796445
Brief Title
A Phase III Study to Test the Benefit of a New Kind of Anti-cancer Treatment in Patients With Melanoma, After Surgical Removal of Their Tumor
Official Title
GSK 2132231A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resected Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated early following assessment of the two co-primary endpoints showing the lack of efficacy of the study product.
Study Start Date
December 1, 2008 (Actual)
Primary Completion Date
January 27, 2016 (Actual)
Study Completion Date
January 27, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
The purpose of this clinical trial is to evaluate the benefit of the immunotherapeutic product GSK 2132231A in preventing disease relapse when given to melanoma patients, after surgical removal of their tumor. This Protocol Posting has been updated following Amendments 1 of the Protocol, March 2010. The impacted sections are outcome measures and entry criteria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
DERMA, Tumor antigen, Immunotherapeutic, Adjuvant cancer therapy, Melanoma, ASCI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1351 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MAGE-A3 Group
Arm Type
Experimental
Arm Description
Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.
Intervention Type
Drug
Intervention Name(s)
GSK 2132231A
Intervention Description
IM solution, a course of 13 injections administered over 27 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
IM solution, a course of 13 injections administered over 27 months
Primary Outcome Measure Information:
Title
Disease Free Survival (DFS)
Description
DFS = time to event from randomization to the date of first disease recurrence (as assessed by investigator) or the date of death (whatever cause), whichever occurred first. DFS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of a recurrence/death. Types of recurrence to be considered as an event included loco-regional and distant metastases. Any death occurring without prior documentation of tumor recurrence was considered as an event (not censored in the stat. analysis) as this approach was less prone to introduce bias. If no event occurred by the time of analysis, then the time to event was censored at the last assessment date (tumor assessment/visit) of the patient. Any new primary cancer at another site, including second primary melanoma, was not considered as a recurrence and had to be reported as a Serious Adverse Event (SAE).
Time Frame
At Final analysis (Month 30 = Year 2.5)
Title
Disease Free Survival (DFS)
Description
DFS = time to event from randomization to the date of first disease recurrence (as assessed by investigator) or the date of death (whatever cause), whichever occurred first. DFS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of a recurrence/death. Types of recurrence to be considered as an event included loco-regional and distant metastases. Any death occurring without prior documentation of tumor recurrence was considered as an event (not censored in the stat. analysis) as this approach was less prone to introduce bias. If no event occurred by the time of analysis, then the time to event was censored at the last assessment date (tumor assessment/visit) of the patient. Any new primary cancer at another site, including second primary melanoma, was not considered as a recurrence and had to be reported as a Serious Adverse Event (SAE).
Time Frame
At follow-up analysis (up to Year 5)
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall Survival (OS) was defined as the time to event from randomization to the date of death, irrespective of the cause of death. OS was expressed as the person-year rate i.e. the number of patients with death (n) over the sum of the follow-up periods in years (T). Patients alive at the time of the analysis were censored on the date last known to be alive.
Time Frame
At Final analysis (Month 30 = Year 2.5) and at follow-up analysis (up to Year 5)
Title
Disease-free Specific Survival (DFSS)
Description
Disease Free Specific Survival (DFSS) was defined as the time to event from randomization to the date of first recurrence of disease or date of death due to melanoma (cause as assessed by investigator), whichever occurred first. DFSS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of a recurrence/death. Patients who died due to a cause other than the disease under study and patients alive at the time of analysis were censored on the date of last assessment (visit or tumor assessment).
Time Frame
At Final analysis (Month 30 = Year 2.5)
Title
Distant Metastasis-free Survival (DMFS)
Description
Distant Metastasis Free Survival (DMFS) was defined as the time to event from randomization to the date of first distant metastasis or date of death, whichever occurred first. DMFS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of distant metastasis/death. Patients alive and without distant metastases were censored at the date of last assessment (visit or tumor assessment, or date of last tumor assessment as documented during the yearly contact follow-up period).
Time Frame
At Final analysis (Month 30 = Year 2.5)
Title
Health-related Quality of Life
Description
The assessment of health-related quality of life was restricted to patients who consented to study participation after Protocol Amendment 1 became effective at their study site, and for whom a validated version of the Euro Quality of Life-5D (EQ-5D) questionnaire was available in their native language. The EQ-5D comprises a 5-dimensional descriptive system (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), where each item has 3 levels and together they define 243 possible health states. For each health state, a value (utility) was determined by using an additive algorithm. These utility scores were calculated for each patient at each timepoint at which an EQ-5D questionnaire was completed. The score had a maximum value of 1.0 corresponding to full health level, while lower scores, down to a minimum value of 0.0 reflected degradation in the health-related quality of life.
Time Frame
At Weeks 0, 6, 12 [on the day of and the day after treatment administration (TA)], at Month 6, 9, 12, 24, at the Concluding visit (Month 30) + 6 months and +12 Months and at disease recurrence
Title
Number of Subjects With Anti-MAGE-A3 Antibody Concentrations Above the Cut-off Value
Description
The cut-off value was 27 Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL).
Time Frame
At Weeks 0, 6, 12, 36, 48 72, 120 (Concluding visit) and at Week 120 + 6 months
Title
Anti-MAGE-A3 Antibody Geometric Mean Concentrations
Description
Anti-MAGE-A3 antibody concentrations were presented as geometric mean concentrations (GMC) and expressed in EL.U/mL.
Time Frame
At Weeks 0, 6, 12, 36, 48 72, 120 (Concluding visit) and at Month 120 + 6 months
Title
Number of Subjects With Anti-MAGE-A3 Antibody Response
Description
Treatment response defined as: - For initially seronegative patients: post-treatment antibody concentration ≥ 27 EL.U/mL; - For initially seropositive patients: post-treatment antibody concentration ≥ 2 fold the pre-treatment antibody concentration.
Time Frame
At Weeks 6, 12, 36, 48 72, 120 (Concluding visit) and at Month 120 + 6 months
Title
Number of Subjects With Abnormal Haematological and Biochemical Parameters
Description
Laboratory abnormalities belong to hematological and biochemical parameters such as: alanine aminotransferase [ALT], asparatate aminostransferase [AST], alkaline phoshatase [AP], bilirubin [BIL], creatinine [CREA], hemoglobin [HGB], leukocytes [LEU], lymphopenia [LYMPH], neutrophils [NEU], platelets [PLA]. Parameter grades (Grade [G] 0, 1, 2, 3, 4, Unknown) were compared to each baseline parameter grade (G Unknown, 0, 1, 2, 3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 of August 9, 2006.
Time Frame
Within the 31-day (Days 0-30) post-treatment period
Title
Number of Subjects With Any Adverse Events (AEs)
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.
Time Frame
Within the 31-day (Days 0-30) follow-up period after treatment
Title
Number of Subjects With Any Serious Adverse Events (SAEs)
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.
Time Frame
From Day 0 up to study end (up to 5 years)
Title
Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
Description
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time Frame
From Day 0 up to study end (up to 5 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent signed. Male or female patient with histologically proven stage IIIB or IIIC cutaneous melanoma presenting with macroscopic lymph node involvement suitable for surgery. The patient must have been surgically rendered free of disease before the randomization. Patient is ≥ 18 years old at the time of signing the informed consent form. The patient's lymph node tumor shows expression of the MAGE-A3 gene. The patient has fully recovered from surgery. ECOG performance status of 0 or 1 at the time of randomization. The patient must have adequate organ functions as assessed by standard laboratory criteria. If the patient is female, she must be of non-childbearing potential, or practice adequate contraception. In the opinion of the investigator, the patient can and will comply with all the requirements of the protocol. Exclusion Criteria: The patient suffers from a mucosal or ocular melanoma. The patient has or has had any history of in-transit metastases The patient has been treated or is scheduled to be treated with an adjuvant anticancer therapy after the surgery that qualifies the patient for inclusion in the present trial. The patient requires concomitant chronic treatment with systemic corticosteroids or any other immunosuppressive agents. Use of any investigational or non-registered product (drug or vaccine) other than the study treatment. The patient has a history of autoimmune disease. The patient has a family history of congenital or hereditary immunodeficiency. The patient is known to be positive for Human Immunodeficiency Virus (HIV) or has another confirmed or suspected immunosuppressive or immunodeficient condition. History of allergic disease or reactions likely to be exacerbated by any component of the treatments. The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures. The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk. The patient has previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured. The patient has an uncontrolled bleeding disorder. For female patients: the patient is pregnant or lactating.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
GSK Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5024
Country
United States
Facility Name
GSK Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
GSK Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0987
Country
United States
Facility Name
GSK Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
GSK Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
GSK Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
GSK Investigational Site
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Facility Name
GSK Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94117-1079
Country
United States
Facility Name
GSK Investigational Site
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403-1757
Country
United States
Facility Name
GSK Investigational Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
GSK Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
GSK Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136-1002
Country
United States
Facility Name
GSK Investigational Site
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
GSK Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
GSK Investigational Site
City
Stuart
State/Province
Florida
ZIP/Postal Code
34994
Country
United States
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
GSK Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2906
Country
United States
Facility Name
GSK Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-7323
Country
United States
Facility Name
GSK Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
GSK Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
GSK Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
GSK Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
GSK Investigational Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
GSK Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
GSK Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
GSK Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
GSK Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
GSK Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48019
Country
United States
Facility Name
GSK Investigational Site
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
GSK Investigational Site
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
GSK Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
GSK Investigational Site
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Facility Name
GSK Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
GSK Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
GSK Investigational Site
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
GSK Investigational Site
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962-1956
Country
United States
Facility Name
GSK Investigational Site
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
GSK Investigational Site
City
Latham
State/Province
New York
ZIP/Postal Code
12110
Country
United States
Facility Name
GSK Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
GSK Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7305
Country
United States
Facility Name
GSK Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
GSK Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
GSK Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
GSK Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
GSK Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
GSK Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
GSK Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
GSK Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
GSK Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
GSK Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-2584
Country
United States
Facility Name
GSK Investigational Site
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
GSK Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
GSK Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
GSK Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
GSK Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6307
Country
United States
Facility Name
GSK Investigational Site
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
GSK Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
GSK Investigational Site
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
GSK Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
GSK Investigational Site
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
GSK Investigational Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
GSK Investigational Site
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
GSK Investigational Site
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
GSK Investigational Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
GSK Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
GSK Investigational Site
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Facility Name
GSK Investigational Site
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
GSK Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
GSK Investigational Site
City
Ciudad Autónoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1050AAK
Country
Argentina
Facility Name
GSK Investigational Site
City
Cipolletti
State/Province
Río Negro
ZIP/Postal Code
R8324EMB
Country
Argentina
Facility Name
GSK Investigational Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000KZE
Country
Argentina
Facility Name
GSK Investigational Site
City
Ciudad Autónoma de Buenos Aires
ZIP/Postal Code
C1121ABE
Country
Argentina
Facility Name
GSK Investigational Site
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2060
Country
Australia
Facility Name
GSK Investigational Site
City
North Sydney
State/Province
New South Wales
ZIP/Postal Code
2060
Country
Australia
Facility Name
GSK Investigational Site
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
GSK Investigational Site
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
GSK Investigational Site
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
GSK Investigational Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
GSK Investigational Site
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
GSK Investigational Site
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
GSK Investigational Site
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
GSK Investigational Site
City
Feldkirch
ZIP/Postal Code
A-6800
Country
Austria
Facility Name
GSK Investigational Site
City
Graz
ZIP/Postal Code
A-8036
Country
Austria
Facility Name
GSK Investigational Site
City
Linz
ZIP/Postal Code
A-4010
Country
Austria
Facility Name
GSK Investigational Site
City
Salzburg
ZIP/Postal Code
A-5020
Country
Austria
Facility Name
GSK Investigational Site
City
Wels
ZIP/Postal Code
A-4600
Country
Austria
Facility Name
GSK Investigational Site
City
Wien
ZIP/Postal Code
A-1030
Country
Austria
Facility Name
GSK Investigational Site
City
Wien
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
GSK Investigational Site
City
Wien
ZIP/Postal Code
A-1220
Country
Austria
Facility Name
GSK Investigational Site
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
GSK Investigational Site
City
Bruxelles
ZIP/Postal Code
1180
Country
Belgium
Facility Name
GSK Investigational Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
GSK Investigational Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
GSK Investigational Site
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
GSK Investigational Site
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30.140-001
Country
Brazil
Facility Name
GSK Investigational Site
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
GSK Investigational Site
City
São Paulo
ZIP/Postal Code
03102-002
Country
Brazil
Facility Name
GSK Investigational Site
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
GSK Investigational Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
GSK Investigational Site
City
Brno
ZIP/Postal Code
656 53
Country
Czechia
Facility Name
GSK Investigational Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
GSK Investigational Site
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
GSK Investigational Site
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
GSK Investigational Site
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
GSK Investigational Site
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
GSK Investigational Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
GSK Investigational Site
City
Besançon cedex
ZIP/Postal Code
25030
Country
France
Facility Name
GSK Investigational Site
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
GSK Investigational Site
City
Boulogne
ZIP/Postal Code
92104
Country
France
Facility Name
GSK Investigational Site
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
GSK Investigational Site
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
GSK Investigational Site
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
GSK Investigational Site
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
GSK Investigational Site
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
GSK Investigational Site
City
Limoges cedex
ZIP/Postal Code
87042
Country
France
Facility Name
GSK Investigational Site
City
Marseille Cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
GSK Investigational Site
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
GSK Investigational Site
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
GSK Investigational Site
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
GSK Investigational Site
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
GSK Investigational Site
City
Paris
ZIP/Postal Code
75006
Country
France
Facility Name
GSK Investigational Site
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
GSK Investigational Site
City
Pierre-Bénite cedex
ZIP/Postal Code
69495
Country
France
Facility Name
GSK Investigational Site
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
GSK Investigational Site
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
GSK Investigational Site
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
GSK Investigational Site
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
GSK Investigational Site
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
GSK Investigational Site
City
Toulouse cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
GSK Investigational Site
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
GSK Investigational Site
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
GSK Investigational Site
City
Freiburg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
79104
Country
Germany
Facility Name
GSK Investigational Site
City
Heidelberg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
GSK Investigational Site
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
GSK Investigational Site
City
Tuebingen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
GSK Investigational Site
City
Ulm
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80337
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80802
Country
Germany
Facility Name
GSK Investigational Site
City
Nuernberg
State/Province
Bayern
ZIP/Postal Code
90419
Country
Germany
Facility Name
GSK Investigational Site
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
Facility Name
GSK Investigational Site
City
Wuerzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
Facility Name
GSK Investigational Site
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
GSK Investigational Site
City
Kassel
State/Province
Hessen
ZIP/Postal Code
34125
Country
Germany
Facility Name
GSK Investigational Site
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35033
Country
Germany
Facility Name
GSK Investigational Site
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
65191
Country
Germany
Facility Name
GSK Investigational Site
City
Greifswald
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
17475
Country
Germany
Facility Name
GSK Investigational Site
City
Buxtehude
State/Province
Niedersachsen
ZIP/Postal Code
21614
Country
Germany
Facility Name
GSK Investigational Site
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
GSK Investigational Site
City
Oldenburg
State/Province
Niedersachsen
ZIP/Postal Code
26133
Country
Germany
Facility Name
GSK Investigational Site
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53127
Country
Germany
Facility Name
GSK Investigational Site
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45122
Country
Germany
Facility Name
GSK Investigational Site
City
Koeln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
GSK Investigational Site
City
Minden
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32429
Country
Germany
Facility Name
GSK Investigational Site
City
Muenster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Facility Name
GSK Investigational Site
City
Ludwigshafen
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67063
Country
Germany
Facility Name
GSK Investigational Site
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
GSK Investigational Site
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
Facility Name
GSK Investigational Site
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39120
Country
Germany
Facility Name
GSK Investigational Site
City
Quedlinburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06484
Country
Germany
Facility Name
GSK Investigational Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
GSK Investigational Site
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
GSK Investigational Site
City
Luebeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Facility Name
GSK Investigational Site
City
Erfurt
State/Province
Thueringen
ZIP/Postal Code
99089
Country
Germany
Facility Name
GSK Investigational Site
City
Jena
State/Province
Thueringen
ZIP/Postal Code
07740
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10249
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13585
Country
Germany
Facility Name
GSK Investigational Site
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
GSK Investigational Site
City
Athens
ZIP/Postal Code
185 47
Country
Greece
Facility Name
GSK Investigational Site
City
Cork
Country
Ireland
Facility Name
GSK Investigational Site
City
Dublin
ZIP/Postal Code
4
Country
Ireland
Facility Name
GSK Investigational Site
City
Dublin
ZIP/Postal Code
7
Country
Ireland
Facility Name
GSK Investigational Site
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
GSK Investigational Site
City
Dublin
ZIP/Postal Code
9
Country
Ireland
Facility Name
GSK Investigational Site
City
Galway
ZIP/Postal Code
Co Galway
Country
Ireland
Facility Name
GSK Investigational Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
GSK Investigational Site
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
GSK Investigational Site
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
GSK Investigational Site
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
GSK Investigational Site
City
Meldola (FC)
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Facility Name
GSK Investigational Site
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41124
Country
Italy
Facility Name
GSK Investigational Site
City
Aviano (PN)
State/Province
Friuli-Venezia-Giulia
ZIP/Postal Code
33081
Country
Italy
Facility Name
GSK Investigational Site
City
Roma
State/Province
Lazio
ZIP/Postal Code
00144
Country
Italy
Facility Name
GSK Investigational Site
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Facility Name
GSK Investigational Site
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
Country
Italy
Facility Name
GSK Investigational Site
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56125
Country
Italy
Facility Name
GSK Investigational Site
City
Siena
State/Province
Toscana
ZIP/Postal Code
53100
Country
Italy
Facility Name
GSK Investigational Site
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
GSK Investigational Site
City
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64710
Country
Mexico
Facility Name
GSK Investigational Site
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
GSK Investigational Site
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
GSK Investigational Site
City
Auckland
ZIP/Postal Code
0622
Country
New Zealand
Facility Name
GSK Investigational Site
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
GSK Investigational Site
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
GSK Investigational Site
City
Oslo
ZIP/Postal Code
0310
Country
Norway
Facility Name
GSK Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
GSK Investigational Site
City
Gdansk
ZIP/Postal Code
80-215
Country
Poland
Facility Name
GSK Investigational Site
City
Kraków
ZIP/Postal Code
31-108
Country
Poland
Facility Name
GSK Investigational Site
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
GSK Investigational Site
City
Poznan
ZIP/Postal Code
61-866
Country
Poland
Facility Name
GSK Investigational Site
City
Slupsk
ZIP/Postal Code
76-200
Country
Poland
Facility Name
GSK Investigational Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
GSK Investigational Site
City
Warszawa
ZIP/Postal Code
04-125
Country
Poland
Facility Name
GSK Investigational Site
City
Baia Mare
ZIP/Postal Code
430031
Country
Romania
Facility Name
GSK Investigational Site
City
Cluj-Napoca
Country
Romania
Facility Name
GSK Investigational Site
City
Craiova, Dolj
ZIP/Postal Code
200535
Country
Romania
Facility Name
GSK Investigational Site
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Kursk
ZIP/Postal Code
305035
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
GSK Investigational Site
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
GSK Investigational Site
City
St. Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Stavropol
ZIP/Postal Code
355047
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Belgrad
ZIP/Postal Code
11 000
Country
Serbia
Facility Name
GSK Investigational Site
City
Belgrad
Country
Serbia
Facility Name
GSK Investigational Site
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
GSK Investigational Site
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
GSK Investigational Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
GSK Investigational Site
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
GSK Investigational Site
City
Göteborg
ZIP/Postal Code
SE-413 45
Country
Sweden
Facility Name
GSK Investigational Site
City
Malmö
ZIP/Postal Code
SE-205 20
Country
Sweden
Facility Name
GSK Investigational Site
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden
Facility Name
GSK Investigational Site
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
GSK Investigational Site
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
GSK Investigational Site
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
GSK Investigational Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
GSK Investigational Site
City
Taoyuan Hsien
ZIP/Postal Code
333
Country
Taiwan
Facility Name
GSK Investigational Site
City
Dnipropetrovsk
ZIP/Postal Code
49100
Country
Ukraine
Facility Name
GSK Investigational Site
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
GSK Investigational Site
City
Donetsk
ZIP/Postal Code
83092
Country
Ukraine
Facility Name
GSK Investigational Site
City
Krivoy Rog
ZIP/Postal Code
50048
Country
Ukraine
Facility Name
GSK Investigational Site
City
Kyiv
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
GSK Investigational Site
City
Lviv
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
GSK Investigational Site
City
Chelmsford
State/Province
Essex
ZIP/Postal Code
CM1 7ET
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Belfast, Northern Ireland
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Colchester
ZIP/Postal Code
CO3 3NB
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Poole, Dorset
ZIP/Postal Code
BH15 2JB
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Salisbury
ZIP/Postal Code
SP2 8BJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/Posting.aspx?ID=16038
Citations:
PubMed Identifier
29908991
Citation
Dreno B, Thompson JF, Smithers BM, Santinami M, Jouary T, Gutzmer R, Levchenko E, Rutkowski P, Grob JJ, Korovin S, Drucis K, Grange F, Machet L, Hersey P, Krajsova I, Testori A, Conry R, Guillot B, Kruit WHJ, Demidov L, Thompson JA, Bondarenko I, Jaroszek J, Puig S, Cinat G, Hauschild A, Goeman JJ, van Houwelingen HC, Ulloa-Montoya F, Callegaro A, Dizier B, Spiessens B, Debois M, Brichard VG, Louahed J, Therasse P, Debruyne C, Kirkwood JM. MAGE-A3 immunotherapeutic as adjuvant therapy for patients with resected, MAGE-A3-positive, stage III melanoma (DERMA): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2018 Jul;19(7):916-929. doi: 10.1016/S1470-2045(18)30254-7. Epub 2018 Jun 13.
Results Reference
background
PubMed Identifier
31732522
Citation
Dizier B, Callegaro A, Debois M, Dreno B, Hersey P, Gogas HJ, Kirkwood JM, Vansteenkiste JF, Sequist LV, Atanackovic D, Goeman J, van Houwelingen H, Salceda S, Wang F, Therasse P, Debruyne C, Spiessens B, Brichard VG, Louahed J, Ulloa-Montoya F. A Th1/IFNgamma Gene Signature Is Prognostic in the Adjuvant Setting of Resectable High-Risk Melanoma but Not in Non-Small Cell Lung Cancer. Clin Cancer Res. 2020 Apr 1;26(7):1725-1735. doi: 10.1158/1078-0432.CCR-18-3717. Epub 2019 Nov 15.
Results Reference
background
Links:
URL
https://clinicalstudydatarequest.com
Description
IPD for this study will be made available via the Clinical Study Data Request site.

Learn more about this trial

A Phase III Study to Test the Benefit of a New Kind of Anti-cancer Treatment in Patients With Melanoma, After Surgical Removal of Their Tumor

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