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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01149343
Registration number
NCT01149343
Ethics application status
Date submitted
22/06/2010
Date registered
23/06/2010
Date last updated
20/11/2020
Titles & IDs
Public title
Evaluation of a New Vaccine Treatment for Patients With Metastatic Skin Cancer
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Scientific title
Study of GSK2302025A Antigen-Specific Cancer Immunotherapeutic in Patients With Metastatic Melanoma
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Secondary ID [1]
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2009-016636-13
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Secondary ID [2]
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113173
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma
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Condition category
Condition code
Cancer
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Immunotherapeutic GSK2302025A, different formulations
Experimental: GSK2302025A Cohort 1 - 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.
Experimental: GSK2302025A Cohort 2 - 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.
Experimental: GSK2302025A Cohort 3 - 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.
Experimental: GSK2302025A Cohort 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.
Other interventions: Immunotherapeutic GSK2302025A, different formulations
Intramuscular administration
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Patients With Dose-limiting Toxicity (Phase I)
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Assessment method [1]
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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.
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Timepoint [1]
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During the study treatment (up to Year 4), for all patients
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Primary outcome [2]
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Percentage of Patients With Anti-PReferentially Expressed Antigen of MElanoma (Anti-PRAME) Humoral Immune Response (Phase I)
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Assessment method [2]
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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).
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Timepoint [2]
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After the administration of dose 4, at Week 8
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Primary outcome [3]
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Number of Patients With Best Overall Response to Study Treatment (Phase II)
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Assessment method [3]
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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).
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Timepoint [3]
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During the entire study period - up to Year 4 + 1 month post last study treatment administration
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Secondary outcome [1]
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Number of Patients With Any Unsolicited Adverse Events (AEs), by Maximum Grading
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Assessment method [1]
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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).
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Timepoint [1]
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During the entire study period - up to Year 4 + 1 month post last study treatment administration
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Secondary outcome [2]
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Number of Patients With Serious Adverse Events (SAEs), by Maximum Grading
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Assessment method [2]
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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).
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Timepoint [2]
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During the entire study period - up to Year 4 + 1 month post last study treatment administration
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Secondary outcome [3]
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Number of Patients With Laboratory Abnormalities Versus Baseline, by Maximum Grading
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Assessment method [3]
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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.
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Timepoint [3]
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During the entire study period - up to Year 4 + 1 month post last study treatment administration
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Secondary outcome [4]
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Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading
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Assessment method [4]
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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.
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Timepoint [4]
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During the entire study period - up to Year 4 + 1 month post last study treatment administration
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Secondary outcome [5]
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Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
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Assessment method [5]
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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.
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Timepoint [5]
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During the entire study period - up to Year 4 + 1 month post last study treatment administration
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Secondary outcome [6]
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Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
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Assessment method [6]
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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.
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Timepoint [6]
0
0
During the entire study period - up to Year 4 + 1 month post last study treatment administration
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Secondary outcome [7]
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Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading
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Assessment method [7]
0
0
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.
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Timepoint [7]
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0
During the entire study period - up to Year 4 + 1 month post last study treatment administration
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Secondary outcome [8]
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Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading
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Assessment method [8]
0
0
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.
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Timepoint [8]
0
0
During the entire study period - up to Year 4 + 1 month post last study treatment administration
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Secondary outcome [9]
0
0
Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading
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Assessment method [9]
0
0
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.
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Timepoint [9]
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During the entire study period - up to Year 4 + 1 month post last study treatment administration
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Secondary outcome [10]
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Percentage of Patients With Anti-PRAME Cellular (T-cell) Response (Phase I)
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Assessment method [10]
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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.
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Timepoint [10]
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Up to Data Lock Point at Week 8
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Secondary outcome [11]
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Number of Patients With Anti-PRAME Humoral Immune Response (Phase I & II)
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Assessment method [11]
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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.
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Timepoint [11]
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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
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Secondary outcome [12]
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Number of Patients With Stable Disease (SD), Progressive Disease (PD), Mixed Response (MR) (Phase I & II)
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Assessment method [12]
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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.
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Timepoint [12]
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At 30 days after the last treatment administration for each patient (Week 199)
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Secondary outcome [13]
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Number of Patients With Best Overall Response, Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria (Phase I & II)
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Assessment method [13]
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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".
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Timepoint [13]
0
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At 30 days after the last treatment administration for each patient (Week 199)
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Secondary outcome [14]
0
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Anti-Protein D Humoral Response (Phase I & II)
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Assessment method [14]
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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.
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Timepoint [14]
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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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Secondary outcome [15]
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0
Anti-Cytosine Phosphate Guanosine Oligodeoxynucleotide (CpG) Humoral Response (Phase I & II)
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Assessment method [15]
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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.
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Timepoint [15]
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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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Secondary outcome [16]
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Time to Treatment Failure, Progression Free Survival and Overall Survival (Phase I & II)
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Assessment method [16]
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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.
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Timepoint [16]
0
0
Up to concluding visit, at Week 199
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Secondary outcome [17]
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Duration of Response for Patients With CR, PR and SD or SD/PR Status (Phase II)
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Assessment method [17]
0
0
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.
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Timepoint [17]
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Up to concluding visit, at Week 199
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Eligibility
Key inclusion criteria
1. Male or female patient with histologically proven cutaneous melanoma. Phase I segment:
All melanoma patients with stage IV M1b and stage IV M1c including completely resected
stage IV patients but with the exception of stage IV M1c disease with serum lactate
dehydrogenase > 1.5 x Upper Limit of Normal or with involvement of the Central Nervous
System.
Phase II segment: All melanoma patients with measurable, unresectable stage III
melanoma including in-transit metastasis (with (N3) or without (N2c) nodal metastasis)
and stage IV M1a melanoma. The patient should have documented progressive disease
within 12 weeks of registration into the trial. Patients with resected stage IV and
with stage IV M1b or M1c disease cannot be included.
2. Written informed consent for PRAME expression screening and gene profiling on resected
tumor tissue and for the complete study has been obtained from the patient prior to
shipment of the sample for expression testing and prior to the performance of any
other protocol-specific procedure.
3. The patient is >= 18 years old at the time of signing the first informed consent form.
4. The patient's tumor shows expression of the PRAME antigen as determined by RT-PCR
analysis or any updated technique on fresh tissue sample.
5. Eastern Cooperative Oncology Group performance status of 0 or 1.
6. The patient has adequate bone marrow reserve, renal, adrenal and hepatic function as
assessed by standard laboratory criteria.
7. Female patients of non-childbearing potential may be enrolled in the study.
Non-childbearing potential is defined as current tubal ligation, hysterectomy,
ovariectomy or post-menopause.
8. Female patients of childbearing potential may be enrolled in the study, if the
patient:
- has practiced adequate contraception for 30 days prior to the study product
administration, and
- has a negative pregnancy test on the day of administration, and
- has agreed to continue adequate contraception during the entire treatment period
and for 2 months after the completion of the study product administration series.
9. In the view of the investigator, the patient can and will comply with all the
requirements of the protocol.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. The patient has at any time received systemic chemotherapy, (bio)-chemotherapy or
CTLA-4 monoclonal antibodies for metastatic disease.
2. The patient is scheduled to receive any other anticancer treatment, including but not
limited to (bio)-chemotherapeutic or immunomodulating agents and radiotherapy.
3. The patient has received any cancer immunotherapy containing the PRAME antigen or any
cancer immunotherapy for his/her metastatic disease.
4. The patient requires concomitant treatment (more than 7 consecutive days) with
systemic corticosteroids or any other immunosuppressive agents.
5. Use of any investigational or non-registered product (drug or vaccine) other than the
study product within the 30 days preceding the first ASCI dose injection or planned
use during the study period
6. The patient has (had) previous or concomitant malignancies at other sites (including
carcinoma in situ), 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.
7. The patient has an allergy to any component of the study investigational product or
has a history of previous allergic reactions to vaccinations.
8. The patient has a history of confirmed adrenal dysfunction.
9. The patient has an autoimmune disease such as, but not limited to, multiple sclerosis,
lupus, and inflammatory bowel disease.
10. The patient is known to be positive for the human immunodeficiency virus (HIV).
11. The patient has an uncontrolled bleeding disorder.
12. The patient has a family history of congenital or hereditary immunodeficiency.
13. The patient has psychiatric or addictive disorders that may compromise his/her ability
to give informed consent or to comply with the trial procedures.
14. The patient has other concurrent severe medical problems, unrelated to the malignancy,
that would significantly limit full compliance with the study or expose the patient to
unacceptable risk.
15. For female patients: the patient is pregnant or lactating.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/07/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
19/12/2016
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Sample size
Target
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Accrual to date
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Final
107
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Praha 2
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France
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Bordeaux
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France
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Lille
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France
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Marseille cedex 5
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France
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Nantes
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France
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Reims
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France
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Rennes
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France
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Vandoeuvre les Nancy
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Germany
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Baden-Wuerttemberg
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Germany
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Bayern
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
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Rheinland-Pfalz
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Germany
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Saarland
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Germany
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Schleswig-Holstein
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Germany
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Thueringen
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Germany
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Berlin
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Italy
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Campania
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Italy
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Emilia-Romagna
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Country [22]
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Italy
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State/province [22]
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Liguria
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Country [23]
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Italy
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Lombardia
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Poland
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Gdansk
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Poland
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Poznan
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Poland
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State/province [26]
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Slupsk
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Country [27]
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Russian Federation
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State/province [27]
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Chelyabinsk
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Country [28]
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Russian Federation
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State/province [28]
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Moscow
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Country [29]
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Russian Federation
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State/province [29]
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Pyatigorsk
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Country [30]
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Russian Federation
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State/province [30]
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St. Petersburg
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this clinical study is to examine the safety, immunogenicity and clinical
activity of the immunotherapeutic product GSK2302025A (also referred to as recPRAME + AS15
Antigen-Specific Cancer Immunotherapeutic [ASCI]) administered as a first line treatment in
patients with unresectable and progressive metastatic cutaneous melanoma.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01149343
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Email
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Contact person for public queries
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Address
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01149343
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