Vaccination of Patients With Stage III or IV Malignant Melanoma With Melanoma Antigen Peptides [Melan-A/Mart-1 Analog (ELA), NY-ESO-1b(A) Analog and MAGE-A10] and Montanide Adjuvant
Acronym
Not provided
Organization
Centre Hospitalier Universitaire VaudoisOTHER
Status Module
Record Verification Date
Jun 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 2004
Primary Completion Date
Mar 2013Actual
Completion Date
Mar 2013Actual
First Submitted Date
May 31, 2005
First Submission Date that Met QC Criteria
May 31, 2005
First Posted Date
Jun 1, 2005Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 29, 2017
Results First Submitted that Met QC Criteria
Jun 2, 2020
Results First Posted Date
Jun 18, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 2, 2020
Last Update Posted Date
Jun 18, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Prof Olivier Michielin, M.D., Ph.D., Professor, Centre Hospitalier Universitaire VaudoisPrincipal Investigator
Lead Sponsor
Centre Hospitalier Universitaire VaudoisOTHER
Collaborators
Name
Class
Ludwig Institute for Cancer Research
OTHER
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to determine whether vaccination with melanoma antigen peptides [Melan-A/Mart-1 (both EAA and ELA), NY-ESO-1b analog, Long NY-ESO-1 LP and MAGE-A10] and Montanide, CpG adjuvants and low dose rIL-2 can induce an immune response in melanoma patients and to assess the safety of this vaccination.
Detailed Description
Current peptide vaccines suffer from low efficiency, since they induce only weak immune activation. We have recently confirmed that in humans the immune response was readily detectable in local lymph nodes while no or only weak activation could be identified in circulating lymphocytes. Increased doses of antigen and adjuvant allow a better extension from local to systemic immune responses.
Group 1 : vaccination with Melan-A analog (ELA) peptide + Montanide
Group 2 : vaccination with Melan-A analog (ELA), NY-ESO-1b analog and MAGE-A10 peptides + Montanide
Group 3: vaccination with Melan-A analog (both EAA and ELA), Mage-A10, NY-ESO-1 peptides+ Montanide + CpG adjuvant
Group 4: vaccination with Melan-A (ELA), Mage-A10,long NY-ESO-1LP peptides + Montanide + CpG
Group 5: vaccination with Melan-A (both EAA and ELA), Mage-A10, long NY-ESO-1 LP peptides + Montanide + CpG + low dose rIL-2
Conditions Module
Conditions
Melanoma
Keywords
Immunotherapy
Vaccination
Melanoma
Melan-A/Mart-1 peptide
MAGE-A10 peptide
NY-ESO-1 peptide
Montanide
CpG
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
39Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1. Melan-A ELA
Experimental
500 mcg Melan-A ELA analog peptide + 1 ml Montanide ISA-51
Biological: Melan-A ELA + Montanide
2. Melan-A ELA + NY-ESO-1b + MAGE-A10
Experimental
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide ISA-51
Biological: Melan-A ELA + NY-ESO-1b + MAGE-A10 + Montanide
3. Melan-A ELA + NY-ESO-1b + MAGE-A10 + CpG
Experimental
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide ISA-51 + 2.5 mg CpG-7909/PF-3512676
If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide ISA-51 (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide ISA-51 (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
A maximum of 3 vaccination cycles (cycles 1-3) has been given, each cycle consisting of 4 vaccines in 4 week intervals. The intervals between cycles were 8 weeks. After 3 cycles, patients without major tumor progression requiring other treatment who showed an immunological response received "booster vaccinations" every 3 months.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events)
Safety of the vaccination was assessed according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) scale. The adverse events (AE) and serious adverse events (SAE) were registered at each study visit during the 3 vaccination cycles and boost cycles.
Change from baseline to end of Cycle 1 (3 months), end of Cycle 2 (8 months), end of Cycle 3 (13 months) and end of Boost Cycles (18 months to 23 months).
Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period
Ex vivo frequency of Melan-A-specific CD8+ T cells was measured by multimer technique (tetramer assay) in a multicolor flow cytometry analysis.
The fold change for each time point compared to baseline was calculated as: Melan-A-specific CD8+ T cell frequency at the time point/ Melan-A-specific CD8+ T cell frequency at baseline.
Significant T cell response is defined by at least 2-fold change of Melan-A-specific CD8+ T cell frequency as compared to pre-immunotherapy.
Fold change from baseline in Melan-A-specific CD8+T-cells at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months).
Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period
Ex vivo frequency of Melan-A-specific CD8+ T cells producing IFN-γ (Interferon-gamma) was measured through the Enzyme-Linked Immunosorbent Spot (ELISpot) assay.
The fold change for each time point compared to baseline was calculated as: Melan-A-specific IFN-γ-secreting CD8+ T cell frequency at the time point/ Melan-A-specific IFN-γ-secreting CD8+ T cell frequency at baseline.
Fold change from baseline in Melan-A-specific IFN-γ-secreting CD8+T-cells frequency at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)
Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific CD8+ T Cells During the Vaccination Period
Secondary Outcomes
Measure
Description
Time Frame
Disease Status Assessment During the Vaccination Period
The disease status was assessed by computed tomography (CT) or positron emission tomography (PET)/CT at baseline and after the fourth vaccination of each cycle. During the "booster vaccines" period, imagery examinations were performed every 3 months for patients with measurable disease and every 6 months for patients with non measurable disease.
The tumor response was assessed according to the classification World Health Organization (WHO) 1979 and defined as:
No Evidence of Disease (NED)
Stable disease (SD): Change in size of all measurable lesions (the sum of the products of the greatest and perpendicular parameters), of less than a 25% increase or 25% decrease from baseline for at least 4 weeks, without appearance of new lesions or progression of any lesion.
Progressing disease (PD): Appearance of new tumors, or increase in size of any measurable tumor by at least 25% of the sum of the product of the greatest and perpendicular diameter.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed stage III or stage IV melanoma with at least one metastatic lymph node and/or at least one in-transit metastasis. According to the AJCC rules, this includes all patients with stage IV and stage III. Patients with or without measurable disease may be included.
Tumor expression of Melan-A by reverse transcriptase and polymerase chain reaction (RT-PCR) analysis for patients of group I.
Tumor expression of Melan-A and at least one of the tumor antigens MAGE-A10, NY-ESO-1, or LAGE-1 by rt-PCR analysis for patients of group II and III and for HLA-A2+ patients of groups IV and V. HLA-A2 negative patients of groups IV and V must only have NY-ESO-1 positive tumors to be eligible, while expression of Melan-A and MAGE-A10 is unimportant.
If no frozen tissue is available, immunohistochemistry may be performed to detect tumor expression of Melan-A and NY-ESO-1.
HLA-A2 positive (serological or molecular typing of Peripheral Blood Lymphocytes (PBL) for patients of groups 1 to 3. Patients of groups 4 and 5 may either be HLA-A2+ or HLA-A2-.
Expected survival of at least five months.
Full recovery from surgery.
Karnofsky scale performance status of 70% or more.
The following laboratory results:
Neutrophil count sup or equal 2.0 x 10^9/L Lymphocyte count sup or equal 0.5 x 10^9/L Platelet count sup or equal 100 x 10^9/L Creatinine ≤ 2 mg/dL (180 micromol/L) Bilirubin ≤ 2mg/dL (34 micromol/L) Granulocyte count > 2.5x10^9/L AST < 2x upper limit of normal aPTT: within the normal ranges of the laboratory ± 25 %
Age > 18 years.
Able to give written informed consent.
Exclusion Criteria:
Clinically significant heart disease (NYHA Class III or IV).
Other serious illnesses, e.g., serious infections requiring antibiotics, uncontrolled peptic ulcer, or central nervous system disorders with major dysfunction.
History of immunodeficiency disease or autoimmune disease.
Known HIV positivity.
Known seropositivity for hepatitis B surface antigen.
Chemotherapy, radiation therapy, or immunotherapy within 4 weeks before study entry (6 weeks for nitrosoureas).
Concomitant treatment with steroids, antihistamine drugs. Topical or inhalational steroids are permitted.
Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
Pregnancy or lactation.
Women of childbearing potential not using a medically acceptable means of contraception.
Psychiatric or addictive disorders that may compromise the ability to give informed consent.
Lack of availability of the patient for immunological and clinical follow-up assessment.
Coagulation or bleeding disorders.
Metastatic disease to the central nervous system, unless treated and stable.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Olivier Michielin, MD PhD
Lausanne University Hospital (Centre Hospitalier Universitaire Vaudois)
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Oncology Department, Lausanne University Hospital (CHUV) and University of Lausanne
Baumgaertner P, Costa Nunes C, Cachot A, Maby-El Hajjami H, Cagnon L, Braun M, Derre L, Rivals JP, Rimoldi D, Gnjatic S, Abed Maillard S, Marcos Mondejar P, Protti MP, Romano E, Michielin O, Romero P, Speiser DE, Jandus C. Vaccination of stage III/IV melanoma patients with long NY-ESO-1 peptide and CpG-B elicits robust CD8+ and CD4+ T-cell responses with multiple specificities including a novel DR7-restricted epitope. Oncoimmunology. 2016 Sep 9;5(10):e1216290. doi: 10.1080/2162402X.2016.1216290. eCollection 2016.
The assignment to a group was done according to tumor antigen (i.e., Melan-A, MAGE-A10, NY-ESO-1b[A]) and HLA expression (HLA-A2).
Recruitment Details
Subjects were screened and enrolled at 2 sites in Switzerland, the CHUV in Lausanne and the HUG in Geneva.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
1. Melan-A ELA
500 mcg Melan-A ELA analog peptide + 1 ml Montanide
FG001
2. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Experimental
If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide ISA-51 (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide ISA-51 (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
A maximum of 3 vaccination cycles (cycles 1-3) has been given, each cycle consisting of 4 vaccines in 4 week intervals. The intervals between cycles were 8 weeks. After 3 cycles, patients without major tumor progression requiring other treatment who showed an immunological response received "booster vaccinations" every 3 months.
A maximum of 3 vaccination cycles (cycles 1-3) has been given, each cycle consisting of 4 vaccines in 4 week intervals. The intervals between cycles were 8 weeks. After 3 cycles, patients without major tumor progression requiring other treatment who showed an immunological response received "booster vaccinations" every 3 months.
A maximum of 3 vaccination cycles (cycles 1-3) has been given, each cycle consisting of 4 vaccines in 4 week intervals. The intervals between cycles were 8 weeks. After 3 cycles, patients without major tumor progression requiring other treatment who showed an immunological response received "booster vaccinations" every 3 months.
A maximum of 3 vaccination cycles (cycles 1-3) has been given, each cycle consisting of 4 vaccines in 4 week intervals. The intervals between cycles were 8 weeks. After 3 cycles, patients without major tumor progression requiring other treatment who showed an immunological response received "booster vaccinations" every 3 months.
Ex vivo frequency of NY-ESO-1-specific CD8+ T cells was measured by multimer technique (tetramer assay) in a multicolor flow cytometry analysis.
The fold change for each time point compared to baseline was calculated as: NY-ESO-1-specific CD8+ T cell frequency at the time point/ NY-ESO-1-specific CD8+ T cell frequency at baseline.
Fold change from baseline in NY-ESO-1-specific CD8+T-cells at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)
Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period
Ex vivo frequency of NY-ESO-1-specific CD8+ T cells producing IFN-γ (Interferon-gamma) was measured through the Enzyme-Linked Immunosorbent Spot (ELISpot) assay.
The fold change for each time point compared to baseline was calculated as: NY-ESO-1-specific IFN-γ-secreting CD8+ T cell frequency at the time point/ NY-ESO-1-specific IFN-γ-secreting CD8+ T cell frequency at baseline.
Fold change from baseline in NY-ESO-1-specific IFN-γ-secreting CD8+T-cells frequency at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)
Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific CD8+ T Cells During the Vaccination Period
Ex vivo frequency of MAGE-A10-specific CD8+ T cells was measured by multimer technique (tetramer assay) in a multicolor flow cytometry analysis.
The fold change for each time point compared to baseline was calculated as: MAGE-A10-specific CD8+ T cell frequency at the time point/ MAGE-A10-specific CD8+ T cell frequency at baseline.
Fold change from baseline in MAGE-A10-specific CD8+T-cells at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)
Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period
Ex vivo frequency of MAGE-A10-specific CD8+ T cells producing IFN-γ (Interferon-gamma) was measured through the Enzyme-Linked Immunosorbent Spot (ELISpot) assay.
The fold change for each time point compared to baseline was calculated as: MAGE-A10-specific IFN-γ-secreting CD8+ T cell frequency at the time point/ MAGE-A10-specific IFN-γ-secreting CD8+ T cell frequency at baseline.
Fold change from baseline in MAGE-A10-specific IFN-γ-secreting CD8+T-cells frequency at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)
Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period
For each patient, total CD4+ T-cells were stimulated in the presence of peptide NY-ESO-1 long peptide (lp). After 10 days, cell cultures were challenged for 4h with the peptide or left unchallenged. The activation of NY-ESO-1 long peptide (lp)-specific CD4+ T cells were analyzed in vitro by Intracellular Cytokine Staining (ICS) via detection of IFN-γ (Interferon-gamma) and TNF-α (Tumor Necrosis Factor-alpha) producing cells.
Percentage of NY-ESO-1 lp-specific IFN-γ/TNF-α -secreting CD4+ T-cells at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)
Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period
For each patient, total CD8+ T cells were stimulated in the presence of peptide NY-ESO-1 long peptide (lp). After 10 days, cell cultures were challenged for 4h with the peptide or left unchallenged. The activation of NY-ESO-1 long peptide (lp)-specific CD8+ T cells were analyzed in vitro by Intracellular Cytokine Staining (ICS) via detection of IFN-γ (Interferon-gamma) and TNF-α (Tumor Necrosis Factor-alpha) producing cells.
Percentage of NY-ESO-1 lp-specific IFN-γ/TNF-α -secreting CD8+ T cells at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)
Disease status at baseline, after cycle 1 (3 months), after cycle 2 (8 months), after cycle 3 (13 months) and if applicable after boost cycles (16 months, 19 months or 22 months)
Division of Oncology at the Geneva University Hospital
Geneva
1211
Switzerland
Result
Hebeisen M, Schmidt J, Guillaume P, Baumgaertner P, Speiser DE, Luescher I, Rufer N. Identification of Rare High-Avidity, Tumor-Reactive CD8+ T Cells by Monomeric TCR-Ligand Off-Rates Measurements on Living Cells. Cancer Res. 2015 May 15;75(10):1983-91. doi: 10.1158/0008-5472.CAN-14-3516. Epub 2015 Mar 25.
Bordry N, Costa-Nunes CM, Cagnon L, Gannon PO, Abed-Maillard S, Baumgaertner P, Murray T, Letovanec I, Lazor R, Bouchaab H, Rufer N, Romano E, Michielin O, Speiser DE. Pulmonary sarcoid-like granulomatosis after multiple vaccinations of a long-term surviving patient with metastatic melanoma. Cancer Immunol Res. 2014 Dec;2(12):1148-53. doi: 10.1158/2326-6066.CIR-14-0143. Epub 2014 Oct 2.
Costa-Nunes C, Cachot A, Bobisse S, Arnaud M, Genolet R, Baumgaertner P, Speiser DE, Sousa Alves PM, Sandoval F, Adotevi O, Reith W, Protti MP, Coukos G, Harari A, Romero P, Jandus C. High-throughput Screening of Human Tumor Antigen-specific CD4 T Cells, Including Neoantigen-reactive T Cells. Clin Cancer Res. 2019 Jul 15;25(14):4320-4331. doi: 10.1158/1078-0432.CCR-18-1356. Epub 2019 Apr 23.
FG002
3. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
FG003
4. Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG
If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
FG00010 subjects
FG0015 subjects
FG0025 subjects
FG00310 subjects
FG0049 subjectsOne patient received only 1 vaccine however this minimum dose allowed the safety evaluation
Cycle 1 Completed
FG00010 subjects
FG0015 subjects
FG0025 subjects
FG0039 subjects
FG0047 subjects
Cycle 2 Completed
FG0008 subjects
FG0013 subjects
FG0024 subjects
FG0038 subjects
FG0044 subjects
Cycle 3 Completed
FG0005 subjects
FG0013 subjects
FG0024 subjects
FG0034 subjects
FG0042 subjects
COMPLETED
Received 3 cycles of treatment
FG0005 subjects
FG0013 subjects
FG0024 subjects
FG0034 subjects
FG0042 subjects
NOT COMPLETED
FG0005 subjects
FG0012 subjects
FG0021 subjects
FG0036 subjects
FG0047 subjects
At study entry the melanoma antigens expression and HLA expression analysis was done in order to know at what group of treatment the patient had to be assigned
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Single Peptide Vaccination
Montanide + Melan-A analogue peptide
Montanide + Melan-A analogue peptide: 1 ml Montanide+ 500 mcg Melan-A analog peptide
BG001
Peptide Combination Vaccination
Montanide + Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide
Montanide + Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide: 1 ml Montanide + 500 mcg Melan-A analog peptide + 500 mcg NY-ESO-1 analog peptide + 500 mcg Mage10 peptide
BG002
Peptide Combination Vaccination + CpG
Montanide + CpG-7909/PF-3512676+Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide
Montanide + CpG-7909 / PF-3512676+Melan-A analog peptide + NY-ESO-1 analog peptide + Mage10 peptide: 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676 + 500 mcg Melan-A analog peptide, 500 mcg + NY-ESO-1 analog peptide + 500 mcg Mage10 peptide
BG003
Native and Analog Peptide Combination Vaccination + CpG
Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + Mage10 peptide
Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + Mage10 peptide: 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676 + 100 mcg Melan-A native and analog peptides + 500 mcg NY-ESO-1 long peptide + 100 mcg Mage10 peptide
BG004
Native and Analog Peptide Combination Vaccination + CpG + IL-2
Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + Mage10 peptide + low dose IL-2
Montanide + CpG-7909/PF-3512676 + Melan-A native and analog peptides + NY-ESO-1 long peptide + Mage10 peptide + low dose IL-2: 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676 + 100 mcg Melan-A native and analog peptides + 500 mcg NY-ESO-1 long peptide + 100 mcg Mage10 peptide + low dose IL-2
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00010
BG0015
BG0025
BG00310
BG0048
BG00538
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Median
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00061.8(34.1 to 77.1)
BG00158.8(37.8 to 73.8)
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0012
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
Switzerland
Title
Measurements
BG00010
BG0015
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in Mean Number of Adverse Events (Serious and Non Serious Events)
Safety of the vaccination was assessed according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) scale. The adverse events (AE) and serious adverse events (SAE) were registered at each study visit during the 3 vaccination cycles and boost cycles.
After the end of a cycle, patients could have discontinue the study for personal reasons or PD. This is why the overall number of patients analyzed could change between cycles of each arm/group.
Posted
Mean
Standard Deviation
Number of adverse events
Change from baseline to end of Cycle 1 (3 months), end of Cycle 2 (8 months), end of Cycle 3 (13 months) and end of Boost Cycles (18 months to 23 months).
ID
Title
Description
OG000
1.Melan-A ELA
500 mcg Melan-A ELA analog peptide + 1 ml Montanide
OG001
2.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide
OG002
3.Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
OG003
4.Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG
If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
Units
Counts
Participants
OG00010
OG0015
OG0025
OG003
Title
Denominators
Categories
End of Cycle 1
ParticipantsOG00010
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG003
Primary
Fold Change From Baseline in ex Vivo Melan-A-specific CD8+ T Cells Frequency During the Vaccination Period
Ex vivo frequency of Melan-A-specific CD8+ T cells was measured by multimer technique (tetramer assay) in a multicolor flow cytometry analysis.
The fold change for each time point compared to baseline was calculated as: Melan-A-specific CD8+ T cell frequency at the time point/ Melan-A-specific CD8+ T cell frequency at baseline.
Significant T cell response is defined by at least 2-fold change of Melan-A-specific CD8+ T cell frequency as compared to pre-immunotherapy.
This test was only performed in patients HLA-A2 positive and Melan-A peptide positive (groups 1, 2 and 3, some patients from groups 4 and 5)
Posted
Mean
Standard Deviation
Fold change of % Melan-A ELA+ CD8+ T
Fold change from baseline in Melan-A-specific CD8+T-cells at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months).
ID
Title
Description
OG000
1. Melan-A ELA
500 mcg Melan-A ELA analog peptide + 1 ml Montanide
OG001
2. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b (A) analog peptide + 500 mcg Mage-A10 peptide + 1 ml Montanide
OG002
3. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG
Primary
Fold Change From Baseline in ex Vivo Frequency of Melan-A-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period
Ex vivo frequency of Melan-A-specific CD8+ T cells producing IFN-γ (Interferon-gamma) was measured through the Enzyme-Linked Immunosorbent Spot (ELISpot) assay.
The fold change for each time point compared to baseline was calculated as: Melan-A-specific IFN-γ-secreting CD8+ T cell frequency at the time point/ Melan-A-specific IFN-γ-secreting CD8+ T cell frequency at baseline.
This test was only done in patients HLA-A2 positive and Melan-A peptide positive (groups 1, 2 and 3, some patients from groups 4 and 5)
Posted
Mean
Standard Deviation
Fold change of % IFN-γ+ MelanA+ CD8+ T
Fold change from baseline in Melan-A-specific IFN-γ-secreting CD8+T-cells frequency at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)
ID
Title
Description
OG000
1. Melan-A ELA
500 mcg Melan-A ELA analog peptide + 1 ml Montanide
OG001
2. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide
OG002
3. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG
Primary
Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific CD8+ T Cells During the Vaccination Period
Ex vivo frequency of NY-ESO-1-specific CD8+ T cells was measured by multimer technique (tetramer assay) in a multicolor flow cytometry analysis.
The fold change for each time point compared to baseline was calculated as: NY-ESO-1-specific CD8+ T cell frequency at the time point/ NY-ESO-1-specific CD8+ T cell frequency at baseline.
This test was only done in patients HLA-A2 positive and NY-ESO-1 peptide positive (groups 2 and 3)
Posted
Mean
Standard Deviation
Fold change of % NY-ESO-1+ CD8+ T cells
Fold change from baseline in NY-ESO-1-specific CD8+T-cells at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)
ID
Title
Description
OG000
1. Melan-A ELA
500 mcg Melan-A ELA analog peptide + 1 ml Montanide
OG001
2. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide
OG002
3. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
Primary
Fold Change From Baseline in ex Vivo Frequency of NY-ESO-1-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period
Ex vivo frequency of NY-ESO-1-specific CD8+ T cells producing IFN-γ (Interferon-gamma) was measured through the Enzyme-Linked Immunosorbent Spot (ELISpot) assay.
The fold change for each time point compared to baseline was calculated as: NY-ESO-1-specific IFN-γ-secreting CD8+ T cell frequency at the time point/ NY-ESO-1-specific IFN-γ-secreting CD8+ T cell frequency at baseline.
This test was only done in patients HLA-A2 positive (groups 1, 2 and 3, some patients from groups 4 and 5)
Posted
Mean
Standard Deviation
% of spots from NYESO1 specific CD8 cell
Fold change from baseline in NY-ESO-1-specific IFN-γ-secreting CD8+T-cells frequency at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)
ID
Title
Description
OG000
1. Melan-A ELA
500 mcg Melan-A ELA analog peptide + 1 ml Montanide
OG001
2. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide
OG002
3. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG
Primary
Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific CD8+ T Cells During the Vaccination Period
Ex vivo frequency of MAGE-A10-specific CD8+ T cells was measured by multimer technique (tetramer assay) in a multicolor flow cytometry analysis.
The fold change for each time point compared to baseline was calculated as: MAGE-A10-specific CD8+ T cell frequency at the time point/ MAGE-A10-specific CD8+ T cell frequency at baseline.
This test was only done in patients MAGE-A10 positive and HLA-A2 positive (groups 2 and 3, some patients from groups 4 and 5)
Posted
Mean
Standard Deviation
Fold change of % MAGE-A10+ CD8+ T cells
Fold change from baseline in MAGE-A10-specific CD8+T-cells at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)
ID
Title
Description
OG000
1. Melan-A ELA
500 mcg Melan-A ELA analog peptide + 1 ml Montanide
OG001
2. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide
OG002
3. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
Primary
Fold Change From Baseline in ex Vivo Frequency of MAGE-A10-specific IFN-γ-secreting CD8+ T Cells During the Vaccination Period
Ex vivo frequency of MAGE-A10-specific CD8+ T cells producing IFN-γ (Interferon-gamma) was measured through the Enzyme-Linked Immunosorbent Spot (ELISpot) assay.
The fold change for each time point compared to baseline was calculated as: MAGE-A10-specific IFN-γ-secreting CD8+ T cell frequency at the time point/ MAGE-A10-specific IFN-γ-secreting CD8+ T cell frequency at baseline.
This test was only done in patients HLA-A2 positive (groups 1, 2 and 3, some patients from groups 4 and 5)
Posted
Mean
Standard Deviation
Fold change of % IFN-γ+ MAGE-A10+ CD8+ T
Fold change from baseline in MAGE-A10-specific IFN-γ-secreting CD8+T-cells frequency at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)
ID
Title
Description
OG000
1. Melan-A ELA
500 mcg Melan-A ELA analog peptide + 1 ml Montanide
OG001
2. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide
OG002
3. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG
Primary
Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNF-α -Secreting CD4+ T Cells During the Vaccination Period
For each patient, total CD4+ T-cells were stimulated in the presence of peptide NY-ESO-1 long peptide (lp). After 10 days, cell cultures were challenged for 4h with the peptide or left unchallenged. The activation of NY-ESO-1 long peptide (lp)-specific CD4+ T cells were analyzed in vitro by Intracellular Cytokine Staining (ICS) via detection of IFN-γ (Interferon-gamma) and TNF-α (Tumor Necrosis Factor-alpha) producing cells.
Patients vaccinated with the NY-ESO-1 lp (groups 4 and 5). One patient of the group 5 received only one vaccine and thus was not included in the analysis of the immune response (the minimum dose required for immune response evaluation was 2 vaccines).
Posted
Mean
Standard Deviation
% of NY-ESO-1 lp specific CD4+ T cells
Percentage of NY-ESO-1 lp-specific IFN-γ/TNF-α -secreting CD4+ T-cells at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)
ID
Title
Description
OG000
1. Melan-A ELA
500 mcg Melan-A ELA analog peptide + 1 ml Montanide
OG001
2. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide
Primary
Percentage of in Vitro Stimulated NY-ESO-1 Lp-specific IFN-γ/TNFα -Secreting CD8+ T Cells During the Vaccination Period
For each patient, total CD8+ T cells were stimulated in the presence of peptide NY-ESO-1 long peptide (lp). After 10 days, cell cultures were challenged for 4h with the peptide or left unchallenged. The activation of NY-ESO-1 long peptide (lp)-specific CD8+ T cells were analyzed in vitro by Intracellular Cytokine Staining (ICS) via detection of IFN-γ (Interferon-gamma) and TNF-α (Tumor Necrosis Factor-alpha) producing cells.
Patients vaccinated with the NY-ESO-1 lp (groups 4 and 5). One patient of the group 5 received only one vaccine and thus was not included in the analysis of the immune response (the minimum dose required for immune response evaluation was 2 vaccines).
Posted
Mean
Standard Deviation
% of NY-ESO-1 lp specific CD8+ T cells
Percentage of NY-ESO-1 lp-specific IFN-γ/TNF-α -secreting CD8+ T cells at the end of Cycle 1 (3 months), at the end of Cycle 2 (8 months), at the end of Cycle 3 (13 months) and if applicable at the end of Boost cycles (18 to 24 months)
ID
Title
Description
OG000
1. Melan-A ELA
500 mcg Melan-A ELA analog peptide + 1 ml Montanide
OG001
2. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide
Secondary
Disease Status Assessment During the Vaccination Period
The disease status was assessed by computed tomography (CT) or positron emission tomography (PET)/CT at baseline and after the fourth vaccination of each cycle. During the "booster vaccines" period, imagery examinations were performed every 3 months for patients with measurable disease and every 6 months for patients with non measurable disease.
The tumor response was assessed according to the classification World Health Organization (WHO) 1979 and defined as:
No Evidence of Disease (NED)
Stable disease (SD): Change in size of all measurable lesions (the sum of the products of the greatest and perpendicular parameters), of less than a 25% increase or 25% decrease from baseline for at least 4 weeks, without appearance of new lesions or progression of any lesion.
Progressing disease (PD): Appearance of new tumors, or increase in size of any measurable tumor by at least 25% of the sum of the product of the greatest and perpendicular diameter.
Some patients discontinued treatment for either personal reasons or progressing disease. This is why from one cycle to other could be a decrease in the number of patients in the study.
Posted
Count of Participants
Participants
Disease status at baseline, after cycle 1 (3 months), after cycle 2 (8 months), after cycle 3 (13 months) and if applicable after boost cycles (16 months, 19 months or 22 months)
ID
Title
Description
OG000
1. Melan-A ELA
500 mcg Melan-A ELA analog peptide + 1 ml Montanide
OG001
2. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10
Time Frame
Adverse events (AE) were collected during the whole study period, from the first vaccination visit (V1, Day 0) to the last vaccination visit (V12) of the cycle 3 of vaccination (13 months) and if applicable during the boost periods (18 months to 23 months) therefore the adverse events were collected for 13 months if patients completed 3 cycles of vaccination and for 18 months to 23 months depending if patients received boost vaccinations.
Description
Adverse events (AE) that were expected (prelisted AE) and non expected (non prelisted AE), according to the Investigator's Brochure of the different vaccine components, were recorded during each visit from the first vaccination until the-end of the third cycle. During the "booster vaccinations" period, any AE were recorded the day of the vaccination and 7 days later. All AE were collected irrespective of their frequency, their severity and relationship to the study drug.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
1. Melan-A ELA
500 mcg Melan-A ELA analog peptide + 1 ml Montanide
0
10
1
10
10
10
EG001
2. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide
0
5
1
5
5
5
EG002
3. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
0
5
1
5
5
5
EG003
4. Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG
If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
0
9
2
9
9
9
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nephrectomy
Renal and urinary disorders
MedDRA (7.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected9 at risk
Renal colic
Renal and urinary disorders
MedDRA (7.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0012 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Pulmonary granuloma
Respiratory, thoracic and mediastinal disorders
MedDRA (7.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Post procedural infection
Infections and infestations
MedDRA (7.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Regional chemotherapy
Surgical and medical procedures
MedDRA (7.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Dehydration
General disorders
MedDRA (7.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (7.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Confusional state/ Dysarthria
Nervous system disorders
MedDRA (7.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Erysipelas
Infections and infestations
MedDRA (7.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (7.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Injection site erythema
Skin and subcutaneous tissue disorders
MedDRA (7.1)
Systematic Assessment
Local Reactions
EG00024 events7 affected10 at risk
EG00138 events5 affected5 at risk
EG00272 events5 affected5 at risk
EG00370 events9 affected10 at risk
Injection site induration
Skin and subcutaneous tissue disorders
MedDRA (7.1)
Systematic Assessment
Local Reactions
EG00055 events9 affected10 at risk
EG00144 events5 affected5 at risk
EG00270 events5 affected5 at risk
EG003
Injection site Pain
Skin and subcutaneous tissue disorders
MedDRA (7.1)
Systematic Assessment
Local Reactions
EG00016 events6 affected10 at risk
EG00121 events4 affected5 at risk
EG00247 events5 affected5 at risk
EG003
Injection site recall reaction
Skin and subcutaneous tissue disorders
MedDRA (7.1)
Systematic Assessment
Local Reactions
EG0007 events4 affected10 at risk
EG0015 events2 affected5 at risk
EG0022 events2 affected5 at risk
EG003
Injection site Warmth
Skin and subcutaneous tissue disorders
MedDRA (7.1)
Systematic Assessment
Local Reactions
EG0008 events4 affected10 at risk
EG00113 events1 affected5 at risk
EG00244 events4 affected5 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (7.1)
Systematic Assessment
Prelisted Systemic Reactions
EG0004 events4 affected10 at risk
EG0013 events2 affected5 at risk
EG0029 events2 affected5 at risk
EG003
Asthenia
General disorders
MedDRA (7.1)
Systematic Assessment
Prelisted Systemic Reactions
EG0004 events3 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Chills
General disorders
MedDRA (7.1)
Systematic Assessment
Prelisted Systemic Reactions
EG0003 events2 affected10 at risk
EG0012 events2 affected5 at risk
EG00216 events3 affected5 at risk
EG003
Fever
General disorders
MedDRA (7.1)
Systematic Assessment
Prelisted Systemic Reactions
EG00010 events2 affected10 at risk
EG0010 events0 affected5 at risk
EG00216 events3 affected5 at risk
EG003
Headache
Nervous system disorders
MedDRA (7.1)
Systematic Assessment
Prelisted Systemic Reactions
EG0004 events2 affected10 at risk
EG0018 events3 affected5 at risk
EG00215 events3 affected5 at risk
EG003
influenza-like illness
General disorders
MedDRA (7.1)
Systematic Assessment
Prelisted Systemic Reactions
EG0001 events1 affected10 at risk
EG0011 events1 affected5 at risk
EG00232 events4 affected5 at risk
EG003
Malaise
General disorders
MedDRA (7.1)
Systematic Assessment
Prelisted Systemic Reactions
EG0001 events1 affected10 at risk
EG0012 events2 affected5 at risk
EG00214 events4 affected5 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (7.1)
Systematic Assessment
Prelisted Systemic Reactions
EG0006 events5 affected10 at risk
EG0011 events1 affected5 at risk
EG00210 events2 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (7.1)
Systematic Assessment
Prelisted Systemic Reactions
EG0000 events0 affected10 at risk
EG0013 events2 affected5 at risk
EG00212 events3 affected5 at risk
EG003
Pruritus
General disorders
MedDRA (7.1)
Systematic Assessment
Prelisted Systemic Reactions
EG0007 events4 affected10 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Ear Discharge
Ear and labyrinth disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Chronic otitis
Ear and labyrinth disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Gynecomastia
Endocrine disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Chest pain-cardiac
Cardiac disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Myocardial ischemia
Cardiac disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Heart murmurs
Cardiac disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0002 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Tachycardi
Cardiac disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0002 events1 affected10 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Ventricular arythmia
Cardiac disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Cardiac shock
Cardiac disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Decrease visual field
Eye disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Eye irritation
Eye disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Visual troubles
Eye disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0002 events2 affected10 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0003 events2 affected10 at risk
EG0012 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Colitic lesions
Gastrointestinal disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Gastrointestinal disorders
Gastrointestinal disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Glossitis
Gastrointestinal disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Odynosphagia
Gastrointestinal disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Oral Aphtha
Gastrointestinal disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Gastroenteritis
Gastrointestinal disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Left hypoesthesia mouth
Gastrointestinal disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Sensitivity of teeth
Gastrointestinal disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Discomfort
General disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
fatigue
Gastrointestinal disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0006 events5 affected10 at risk
EG0014 events3 affected5 at risk
EG0024 events1 affected5 at risk
EG003
pain
General disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0003 events3 affected10 at risk
EG0012 events1 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Oedema
General disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0004 events3 affected10 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Localized oedema
General disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0023 events2 affected5 at risk
EG003
Infusion site extravasation
General disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Throat glar
General disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Immune system disorders
Immune system disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Granuloma
Immune system disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0018 events3 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Hepatic cysts
Hepatobiliary disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Cystitis
Infections and infestations
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Erysipelas
Infections and infestations
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Folliculitis
Infections and infestations
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Herpes labialis
Infections and infestations
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Infection inguinal scar
Infections and infestations
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Post-operative infection
Infections and infestations
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Prostate infection
Infections and infestations
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Bronchial infection
Infections and infestations
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Laryngitis
Infections and infestations
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Mucosal infection
Infections and infestations
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Skin infection
Infections and infestations
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Pharyngitis
Immune system disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0012 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Lund injury
Injury, poisoning and procedural complications
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Anemia
Investigations
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Elevated CK
Investigations
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Karnofsky scale worsened
Investigations
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0008 events5 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Elevated liver values (due to Dafalgan)
Investigations
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Platelet count decreased
Investigations
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Lymphopenia
Investigations
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
GGT increased
Investigations
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
High ALP level
Investigations
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
High LDH level
Investigations
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected5 at risk
EG003
High C-Reactive Protein
Investigations
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Increased of liver enzymes values
Investigations
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Weight decreased
Investigations
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Weight increased
Investigations
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0022 events1 affected5 at risk
EG003
Weight loss
Investigations
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0004 events2 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0002 events2 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Hypokalemia
Metabolism and nutrition disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Dehydratation
Metabolism and nutrition disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 affected5 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Muscle weakness lower limb
Musculoskeletal and connective tissue disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Axillary pain
Musculoskeletal and connective tissue disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0003 events2 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0002 events2 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Metastatic malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG00010 events4 affected10 at risk
EG0011 events1 affected5 at risk
EG00211 events3 affected5 at risk
EG003
Metastasis skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0003 events3 affected10 at risk
EG0017 events3 affected5 at risk
EG0022 events1 affected5 at risk
EG003
Prostatic hyperplasia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Inguinal adenophathy
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0003 events3 affected10 at risk
EG0012 events2 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Axillary adenopathy
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0023 events1 affected5 at risk
EG003
Mediastinal adenopathy
Musculoskeletal and connective tissue disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Cysts
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Black nodule on scar
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Increased renal kystis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Liver hemangiomas
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Neoplasms benign, malignant and unspecified-subcutaneous nodule
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0009 events4 affected10 at risk
EG0014 events2 affected5 at risk
EG0025 events2 affected5 at risk
EG003
Ataxia
Nervous system disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0022 events1 affected5 at risk
EG003
Carpal tunnel symdrome
Nervous system disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Convulsion
Nervous system disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Paresthesi
Nervous system disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0005 events3 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Dysarthrya
Nervous system disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Dysesthesia
Nervous system disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Dysphasia
Nervous system disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Migraine
Nervous system disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Sleeping disorders
Nervous system disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Spasticity
Nervous system disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Tremor
Nervous system disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Vasovagal reaction
Nervous system disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Nervous Descompensation
Nervous system disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0002 events2 affected10 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Sensitivity impairment
Nervous system disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Ischemia cerebrovascular
Nervous system disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Temporal lobe
Nervous system disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Agitation
Psychiatric disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Depression
Psychiatric disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Mood alteration
Psychiatric disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Anuria
Renal and urinary disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0012 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Urinary frequency
Renal and urinary disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Amenorrhoea
Reproductive system and breast disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Irregular menstruation
Reproductive system and breast disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Dyspnea
Respiratory, thoracic and mediastinal disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0003 events2 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Chronic cough
Respiratory, thoracic and mediastinal disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Induration
Skin and subcutaneous tissue disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Hyperhydrosis
Skin and subcutaneous tissue disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Itching/Pruritus
Skin and subcutaneous tissue disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Dermohypodermitis
Skin and subcutaneous tissue disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Keratosis lesion
Skin and subcutaneous tissue disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0011 events1 affected5 at risk
EG0022 events1 affected5 at risk
EG003
Macular skin lesion
Skin and subcutaneous tissue disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Skin scab
Skin and subcutaneous tissue disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Ingrown toe nail
Skin and subcutaneous tissue disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Difficult cicatrization
Skin and subcutaneous tissue disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Skin depigmentation
Skin and subcutaneous tissue disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Skin ulceration
Skin and subcutaneous tissue disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0002 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Scar
Skin and subcutaneous tissue disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Pain scar
Skin and subcutaneous tissue disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Haematoma post-biopsy
Surgical and medical procedures
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Motor skills decrease after brain surgery
Surgical and medical procedures
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Lymph node dissection
Surgical and medical procedures
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Metastasis resection
Surgical and medical procedures
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Post-operative pain
Surgical and medical procedures
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Post-operative arythmia
Surgical and medical procedures
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0001 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Punch-biopsy previous injection site
Surgical and medical procedures
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Broken foot toe
Surgical and medical procedures
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Hypertension
Vascular disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0002 events1 affected10 at risk
EG0010 events0 affected5 at risk
EG0022 events2 affected5 at risk
EG003
Hypotension
Vascular disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0003 events2 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Haematoma
Vascular disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0003 events3 affected10 at risk
EG0010 events0 affected5 at risk
EG0023 events2 affected5 at risk
EG003
Hot Flush
Vascular disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Lymphedema
Vascular disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0002 events2 affected10 at risk
EG0012 events2 affected5 at risk
EG0022 events1 affected5 at risk
EG003
Varix
Vascular disorders
MedDRA (7.1)
Systematic Assessment
Non-Prelisted Reactions
EG0000 events0 affected10 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Prof Olivier Michielin
Department of Oncology, Division of Medical Oncology University Hospital Lausanne
+41 21 314 01 85
Olivier.Michielin@chuv.ch
ID
Term
D008545
Melanoma
Ancestor Terms
ID
Term
D018358
Neuroendocrine Tumors
D017599
Neuroectodermal Tumors
D009373
Neoplasms, Germ Cell and Embryonal
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D009380
Neoplasms, Nerve Tissue
D018326
Nevi and Melanomas
D012878
Skin Neoplasms
D009371
Neoplasms by Site
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D058965
MART-1 Antigen
C000712049
Monatide (IMS 3015)
C119317
MAGE-A10 antigen
C015772
cytidylyl-3'-5'-guanosine
Ancestor Terms
ID
Term
D058950
Melanoma-Specific Antigens
D009363
Neoplasm Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D000951
Antigens, Neoplasm
D000941
Antigens
D001685
Biological Factors
Browse Leaves
Not provided
Browse Branches
Not provided
0
BG0040
BG0050
Between 18 and 65 years
BG0006
BG0013
BG0023
BG0038
BG0046
BG00526
>=65 years
BG0004
BG0012
BG0022
BG0032
BG0042
BG00512
64.9
(47.3 to 78.1)
BG00359.9(31.4 to 65.5)
BG00459.2(35.6 to 66.6)
BG00560.1(31.4 to 78.1)
2
BG0032
BG0043
BG00512
Male
BG0007
BG0013
BG0023
BG0038
BG0045
BG00526
5
BG00310
BG0048
BG00538
10
OG0049
10
ParticipantsOG0049
Title
Measurements
OG00013.40± 13.02
OG00118.40± 5.86
OG00223.80± 12.15
OG00319.60± 8.15
OG00431.75± 18.92
End of Cycle 2
ParticipantsOG0009
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0039
ParticipantsOG0045
Title
Measurements
OG00010.44± 7.46
OG00110.00± 7.62
OG00220.25± 13.33
OG003
End of Cycle 3
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0036
ParticipantsOG0042
Title
Measurements
OG0006.20± 4.20
OG00116.00± 9.74
OG00221.25± 12.10
OG003
Boot cycles
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0031
ParticipantsOG0040
Title
Measurements
OG0008.50± 6.54
OG0019.00± 5.81
OG00248.67± 53.87
OG003
500 mcg Melan-A ELA analog peptide, 500 mcg + NY-ESO-1b(A) analog peptide + 500 mcg Mage-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
OG003
4. Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG
If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
Units
Counts
Participants
OG00010
OG0015
OG0025
OG0035
OG0042
Title
Denominators
Categories
Baseline
ParticipantsOG00010
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG0035
ParticipantsOG0042
Title
Measurements
OG0000.03± 0.03
OG0010.01± 0.01
OG0020.08± 0.15
OG003
End of Cycle 1
ParticipantsOG00010
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG0035
End of Cycle 2
ParticipantsOG0008
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
End of Cycle 3
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0032
End of Boost Cycles
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0030
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
OG003
4. Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG
If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
Units
Counts
Participants
OG00010
OG0015
OG0025
OG0035
OG0041
Title
Denominators
Categories
Baseline
ParticipantsOG00010
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG0035
ParticipantsOG0041
Title
Measurements
OG0000.001± 0.002
OG0010.004± 0.006
OG0020.065± 0.129
OG003
End of Cycle 1
ParticipantsOG00010
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG0035
End of Cycle 2
ParticipantsOG0008
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
End of Cycle 3
ParticipantsOG0006
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0031
End of Boost Cycles
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0030
OG003
4. Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG
If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
Units
Counts
Participants
OG0000
OG0015
OG0025
OG0030
OG0040
Title
Denominators
Categories
Baseline
ParticipantsOG0000
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG0030
ParticipantsOG0040
Title
Measurements
OG0010.69± 1.54
OG0020.01± 0.02
End of Cycle 1
ParticipantsOG0000
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG0030
End of Cycle 2
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0030
End of Cycle 3
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0030
End of Boost Cycles
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0030
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
OG003
4. Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG
If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
Units
Counts
Participants
OG00010
OG0015
OG0025
OG0035
OG0041
Title
Denominators
Categories
Baseline
ParticipantsOG00010
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG0035
ParticipantsOG0041
Title
Measurements
OG0000.004± 0.01
OG0010.218± 0.484
OG0020.001± 0.001
OG003
End of Cycle 1
ParticipantsOG00010
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG0035
End of Cycle 2
ParticipantsOG0008
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
End of Cycle 3
ParticipantsOG0006
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0031
End of Boost Cycles
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0030
OG003
4. Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG
If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
Units
Counts
Participants
OG0000
OG0015
OG0025
OG0035
OG0042
Title
Denominators
Categories
Baseline
ParticipantsOG0000
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG0035
ParticipantsOG0042
Title
Measurements
OG0010± 0
OG0020± 0
OG0030± 0
OG004
End of Cycle 1
ParticipantsOG0000
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG0035
End of Cycle 2
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
End of Cycle 3
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
End of Boost Cycles
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0030
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
OG003
4. Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG
If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
Units
Counts
Participants
OG00010
OG0015
OG0025
OG0035
OG0041
Title
Denominators
Categories
Baseline
ParticipantsOG00010
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG0035
ParticipantsOG0041
Title
Measurements
OG0000.001± 0.002
OG0010.003± 0.006
OG0020.014± 0.026
OG003
End of Cycle 1
ParticipantsOG00010
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG0035
End of Cycle 2
ParticipantsOG0008
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
End of Cycle 3
ParticipantsOG0006
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0031
End of Boost Cycles
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0030
OG002
3. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
OG003
4. Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG
If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
Units
Counts
Participants
OG0000
OG0010
OG0020
OG00310
OG0048
Title
Denominators
Categories
NY-ESO-1lp T cells producing IFN-γ at baseline
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00310
ParticipantsOG0048
Title
Measurements
OG0030.12± 0.21
OG004071± 1.30
NY-ESO-1lp T cells producing TNF-α at baseline
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00310
NY-ESO-1lp T cells producing IFN-γ _end of cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
NY-ESO-1lp T cells producing TNF-α_ end of cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
NY-ESO-1lp T cells IFN-γ_end of cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0039
NY-ESO-1lp T cells producing TNF-α _end of cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
NY-ESO-1lp T cells IFN-γ _end of cycle 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0036
NY-ESO-1lp T cells producing TNF-α _end of cycle 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
NY-ESO-1lp T producing IFN-γ _end of boost cycles
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
NY-ESO-1lp T producing TNF-α_end of boost cycles
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
OG002
3. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
OG003
4. Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG
If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
Units
Counts
Participants
OG0000
OG0010
OG0020
OG00310
OG0048
Title
Denominators
Categories
NY-ESO-1lp T cells producing IFN-γ at baseline
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00310
ParticipantsOG0048
Title
Measurements
OG0030.03± 0.08
OG0040.12± 0.17
NY-ESO-1lp T cells producing TNF-α at baseline
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00310
NY-ESO-1lp T cells producing IFN-γ_end of cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00310
NY-ESO-1lp T cells producing TNF-α_end of cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00310
NY-ESO-1lp T cells producing IFN-γ_end of cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0039
NY-ESO-1lp T cells producing TNF-α_end of cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0039
NY-ESO-1lp T cells producing IFN-γ_end of cycle 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0036
NY-ESO-1lp T cells producing TNF-α_end of cycle 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0036
NY-ESO-1lp T producing IFN-γ_end of boost cycles
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
NY-ESO-1lp T producing TNF-α_end of boost cycles
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide
OG002
3. Melan-A ELA + NY-ESO-1b(A) + MAGE-A10 + CpG
500 mcg Melan-A ELA analog peptide + 500 mcg NY-ESO-1b(A) analog peptide + 500 mcg MAGE-A10 peptide + 1 ml Montanide + 2.5 mg CpG-7909/PF-3512676
OG003
4. Melan-A EAA/ELA + NY-ESO-1lp + MAGE-A10+ CpG
If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676
If patient is HLA-A2 positive: 100 mcg Melan-A EAA native peptide (during first cycle) or 100 mcg ELA analog peptide (during other cycles) + 500 mcg NY-ESO-1lp long peptide + 100 mcg MAGE-A10 peptide + 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2
If patient is HLA-A2 negative: 500 mcg NY-ESO-1lp long peptide+ 1 ml Montanide (no Montanide during cycle 3) + 2.5 mg CpG-7909/PF-3512676 + low dose IL-2