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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00199901




Registration number
NCT00199901
Ethics application status
Date submitted
16/09/2005
Date registered
20/09/2005

Titles & IDs
Public title
Study of NY-ESO-1 ISCOMATRIX® in Patients With High-risk, Resected Melanoma
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
Secondary ID [1] 0 0
LUD2003-009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - NY-ESO-1 ISCOMATRIX®
Treatment: Other - ISCOMATRIX® adjuvant

Active comparator: Vaccine - NY-ESO-1 ISCOMATRIX® vaccine

Placebo comparator: Adjuvant Alone - ISCOMATRIX® adjuvant alone


Treatment: Other: 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).

Treatment: Other: 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).
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of Relapse-free Survival at 18 Months
Timepoint [1] 0 0
18 months
Secondary outcome [1] 0 0
Number of Patients With Treatment -Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
18 months
Secondary outcome [2] 0 0
Relapse-Free Survival During the Entire Period of Observation (up to 6 Years).
Timepoint [2] 0 0
through study completion; up to 6 years
Secondary outcome [3] 0 0
Overall Survival
Timepoint [3] 0 0
through study completion; up to 6 years
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Baseline
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Day 71
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Day 197
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
Day 365
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
End of Study (month 18)

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2011
Sample size
Target
Accrual to date
Final
111
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Sydney Melanoma Unit - Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Newcastle Melanoma Unit - Newcastle Mater Misericordiae Hospital - Newcastle
Recruitment hospital [3] 0 0
Mater Medical Centre, Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [5] 0 0
Austin Health (Ludwig Institute Oncology Unit) - Heidelberg
Recruitment hospital [6] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2298 - Newcastle
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Birmingham
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Cambridge
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Glasgow
Country [5] 0 0
United Kingdom
State/province [5] 0 0
London
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Northwood
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Sheffield
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Other
Name
Ludwig Institute for Cancer Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Institute of Cancer Research, United Kingdom
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Prof. Jonathan S Cebon, MBBS PhD
Address 0 0
Ludwig Institute for Cancer Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT00199901