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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00199901
Registration number
NCT00199901
Ethics application status
Date submitted
16/09/2005
Date registered
20/09/2005
Date last updated
12/10/2022
Titles & IDs
Public title
Study of NY-ESO-1 ISCOMATRIX® in Patients With High-risk, Resected Melanoma
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Scientific title
Randomized, Double-blind Phase II Trial of NY-ESO-1 ISCOMATRIX® Vaccine and ISCOMATRIX® Adjuvant Alone in Patients With Resected Stage Ilc, Illb, lIIc, or IV Malignant Melanoma
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Secondary ID [1]
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LUD2003-009
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma
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Condition category
Condition code
Cancer
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - NY-ESO-1 ISCOMATRIX®
Other interventions - ISCOMATRIX® adjuvant
Active Comparator: Vaccine - NY-ESO-1 ISCOMATRIX® vaccine
Placebo Comparator: Adjuvant Alone - ISCOMATRIX® adjuvant alone
Other interventions: NY-ESO-1 ISCOMATRIX®
100 µg of NY-ESO-1 protein formulated with 120 µg of ISCOMATRIX® adjuvant.
Each patient will receive four intramuscular injections of NY-ESO-1 ISCOMATRIX® vaccine. The first three doses will be given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection will be given at month 6 (day 183 ± 3 days).
Other interventions: ISCOMATRIX® adjuvant
120 µg of ISCOMATRIX® adjuvant
Each patient will receive four intramuscular injections of ISCOMATRIX® adjuvant alone. The first three doses will be given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection will be given at month 6 (day 183 ± 3 days).
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Rate of Relapse-free Survival at 18 Months
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Assessment method [1]
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The number of patients who were alive and relapse free 18 months after starting therapy and the number of patients who relapsed or died within 18 months of starting therapy.
Disease was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) as measured by CT. Disease progression or relapse was based on an increase of 20% or more in the sum of the longest diameter of target lesions, the appearance of any new lesion as confirmed by CT scan or death.
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Timepoint [1]
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18 months
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Secondary outcome [1]
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Number of Patients With Treatment -Emergent Adverse Events (TEAEs)
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Assessment method [1]
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Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Adverse events (AEs) were reported based on clinical laboratory tests, vital sign and weight measurements, physical examinations, performance status evaluations, electrocardiograms, magnetic resonance imaging, and any other medically indicated assessments, including subject interviews, from the time informed consent is signed through 18 months. AEs were considered to be treatment emergent (TEAE) if they occurred or worsened in severity after the first dose of study treatment.
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Timepoint [1]
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18 months
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Secondary outcome [2]
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Relapse-Free Survival During the Entire Period of Observation (up to 6 Years).
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Assessment method [2]
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Disease was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) as measured by CT. Disease progression or relapse was based on an increase of 20% or more in the sum of the longest diameter of target lesions, the appearance of any new lesion as confirmed by CT scan or death.
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Timepoint [2]
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through study completion; up to 6 years
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Secondary outcome [3]
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Overall Survival
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Assessment method [3]
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Overall Survival measured during the entire Period of Observation (up to 6years).
Overall survival was measured from start of treatment to the last follow-up or death.
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Timepoint [3]
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through study completion; up to 6 years
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Secondary outcome [4]
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NY-ESO-1 Antibody Response at Baseline Reported on a Scale of 0 to 4 With 0 Being no or Minimal Antibody Response and 4 the Highest Antibody Response
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Assessment method [4]
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NY-ESO-1-specific antibodies were measured by an enzyme-linked immunosorbent assay ( ELISA) method at baseline and on days 71, 197, 365 and end of study. The results are reported as antibodies to NY-ESO-1-specific Total IgG (reciprocal titer) and were scored on a scale of 0-4 with 0 being no or minimal antibody response (reciprocal titer of 0-100) and 4 a strong antibody response (reciprocal titer of >100,000). The number of patients with each antibody response level are tabulated at each timepoint.
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Timepoint [4]
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Baseline
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Secondary outcome [5]
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NY-ESO-1 Antibody Response on Day 71 Reported on a Scale of 0 to 4 With 0 Being no or Minimal Antibody Response and 4 the Highest Antibody Response
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Assessment method [5]
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NY-ESO-1-specific antibodies were measured by an enzyme-linked immunosorbent assay ( ELISA) method at baseline and on days 71, 197, 365 and end of study. The results are reported as antibodies to NY-ESO-1-specific Total IgG (reciprocal titer) and were scored on a scale of 0-4 with 0 being no or minimal antibody response (reciprocal titer of 0-100) and 4 a strong antibody response (reciprocal titer of >100,000). The number of patients with each antibody response level are tabulated at each timepoint.
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Timepoint [5]
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Day 71
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Secondary outcome [6]
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NY-ESO-1 Antibody Response on Day 197 Reported on a Scale of 0 to 4 With 0 Being no or Minimal Antibody Response and 4 the Highest Antibody Response
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Assessment method [6]
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NY-ESO-1-specific antibodies were measured by an enzyme-linked immunosorbent assay ( ELISA) method at baseline and on days 71, 197, 365 and end of study. The results are reported as antibodies to NY-ESO-1-specific Total IgG (reciprocal titer) and were scored on a scale of 0-4 with 0 being no or minimal antibody response (reciprocal titer of 0-100) and 4 a strong antibody response (reciprocal titer of >100,000). The number of patients with each antibody response level are tabulated at each timepoint.
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Timepoint [6]
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Day 197
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Secondary outcome [7]
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NY-ESO-1 Antibody Response on Day 365 Reported on a Scale of 0 to 4 With 0 Being no or Minimal Antibody Response and 4 the Highest Antibody Response
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Assessment method [7]
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NY-ESO-1-specific antibodies were measured by an enzyme-linked immunosorbent assay ( ELISA) method at baseline and on days 71, 197, 365 and end of study. The results are reported as antibodies to NY-ESO-1-specific Total IgG (reciprocal titer) and were scored on a scale of 0-4 with 0 being no or minimal antibody response (reciprocal titer of 0-100) and 4 a strong antibody response (reciprocal titer of >100,000). The number of patients with each antibody response level are tabulated at each timepoint.
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Timepoint [7]
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Day 365
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Secondary outcome [8]
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NY-ESO-1 Antibody Response at End of Study Reported on a Scale of 0 to 4 With 0 Being no or Minimal Antibody Response and 4 the Highest Antibody Response
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Assessment method [8]
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NY-ESO-1-specific antibodies were measured by an enzyme-linked immunosorbent assay ( ELISA) method at baseline and on days 71, 197, 365 and end of study. The results are reported as antibodies to NY-ESO-1-specific Total IgG (reciprocal titer) and were scored on a scale of 0-4 with 0 being no or minimal antibody response (reciprocal titer of 0-100) and 4 a strong antibody response (reciprocal titer of >100,000). The number of patients with each antibody response level are tabulated at each timepoint.
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Timepoint [8]
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End of Study (month 18)
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Eligibility
Key inclusion criteria
- Histologically proven malignant melanoma.
- Tumor expression of NY-ESO-1 antigen by immunohistochemistry.
- Fully resected AJCC stage IIc, IIIb, IIIc or IV melanoma.
- Within six months of surgery for melanoma.
- Full recovery from surgery.
- No immunotherapy or systemic adjuvant therapy for melanoma since most recent relapse
and/or resection. (Previous adjuvant therapy accepted providing patient relapsed and
resected after this.)
- Age 18 years or older.
- Able to give written informed consent.
- Vital laboratory parameters within normal range, or protocol specified ranges.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Other serious or significant illnesses.
- Resected cerebral metastases.
- Ocular melanoma.
- Other malignancy within last 3 years, except for treated non-melanoma skin cancer and
cervical cancer in situ.
- Using immunosuppressive drugs.
- Anticoagulation.
- Known HIV positivity.
- Chemotherapy or radiation therapy in last four weeks (6 weeks for nitrosourea drugs).
- Not available for immunological and clinical follow-up assessments.
- Participation in prior clinical trial involving an investigational agent within last 4
weeks.
- Previous isolated limb perfusion (ILP).
- Pregnancy or breastfeeding.
- Refusal or inability to use effective means of contraception for women of childbearing
potential.
- Mental impairment that may compromise ability to give informed consent and to comply
with study requirements.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2011
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Sample size
Target
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Accrual to date
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Final
111
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Sydney Melanoma Unit - Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Newcastle Melanoma Unit - Newcastle Mater Misericordiae Hospital - Newcastle
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Recruitment hospital [3]
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Mater Medical Centre, Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [4]
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Peter MacCallum Cancer Centre - East Melbourne
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Recruitment hospital [5]
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Austin Health (Ludwig Institute Oncology Unit) - Heidelberg
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Recruitment hospital [6]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2298 - Newcastle
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Recruitment postcode(s) [3]
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4102 - Woolloongabba
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Recruitment postcode(s) [4]
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3002 - East Melbourne
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Recruitment postcode(s) [5]
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3084 - Heidelberg
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Recruitment postcode(s) [6]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Country [2]
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United Kingdom
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State/province [2]
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Birmingham
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Country [3]
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United Kingdom
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State/province [3]
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Cambridge
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Country [4]
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United Kingdom
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State/province [4]
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Glasgow
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Country [5]
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United Kingdom
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State/province [5]
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London
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Country [6]
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United Kingdom
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State/province [6]
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Northwood
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Country [7]
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United Kingdom
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State/province [7]
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Sheffield
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Country [8]
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United Kingdom
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State/province [8]
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Southampton
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Funding & Sponsors
Primary sponsor type
Other
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Name
Ludwig Institute for Cancer Research
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Institute of Cancer Research, United Kingdom
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this trial is to assess whether treatment with NY-ESO-1 ISCOMATRIX® vaccine
improves outcomes for people with Malignant Melanoma which has been removed, but is at high
risk of relapse.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00199901
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof. Jonathan S Cebon, MBBS PhD
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Address
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Ludwig Institute for Cancer Research
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00199901
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