- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00199901
Study of NY-ESO-1 ISCOMATRIX® in Patients With High-risk, Resected Melanoma
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
NY-ESO-1 protein is an immune target found in many cancers including melanoma. ISCOMATRIX® adjuvant enhances immune responses. This trial compares NY-ESO-1 ISCOMATRIX® vaccine with ISCOMATRIX® adjuvant alone to assess whether treatment with NY-ESO-1 ISCOMATRIX® vaccine improves outcomes for participants with Malignant Melanoma which has been removed, but is at high risk of recurrence.
Eligible participants are randomly allocated to a treatment arm. Treatment involves four intramuscular (into a muscle) injections (1 injection every 4 weeks x 3, plus 1 injection at 6 months).
Participants are assessed for recurrence of melanoma, safety and immune responses (by blood test) over the 18 month study period. Off study, their own doctor will follow them for melanoma recurrence and survival.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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New South Wales
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Camperdown, New South Wales, Australia, 2050
- Sydney Melanoma Unit - Royal Prince Alfred Hospital
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Newcastle, New South Wales, Australia, 2298
- Newcastle Melanoma Unit - Newcastle Mater Misericordiae Hospital
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Queensland
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Woolloongabba, Queensland, Australia, 4102
- Mater Medical Centre, Princess Alexandra Hospital
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Victoria
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East Melbourne, Victoria, Australia, 3002
- Peter MacCallum Cancer Centre
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Heidelberg, Victoria, Australia, 3084
- Austin Health (Ludwig Institute Oncology Unit)
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Sir Charles Gairdner Hospital
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Auckland, New Zealand
- University of Auckland (Waitemata DHB)
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Birmingham, United Kingdom, B29 6JD
- University Hospital - Birmingham
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Cambridge, United Kingdom, CB2 2QQ
- Addenbrooke's Hospital
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Glasgow, United Kingdom, G11 6NT
- Western Infirmary
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London, United Kingdom, SW3 6JJ
- Royal Marsden Hospital
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London, United Kingdom, SW17 0RE
- St Georges Hospital
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Northwood, United Kingdom, HA6 2RN
- Mount Vernon Hospital
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Sheffield, United Kingdom, S10 2SJ
- Weston Park Hospital
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Southampton, United Kingdom, SO16 6YD
- Southampton University Hospitals
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Vaccine
NY-ESO-1 ISCOMATRIX® vaccine
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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). |
Placebo Comparator: Adjuvant Alone
ISCOMATRIX® adjuvant alone
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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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Relapse-free Survival at 18 Months
Time Frame: 18 months
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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. |
18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients With Treatment -Emergent Adverse Events (TEAEs)
Time Frame: 18 months
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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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18 months
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Relapse-Free Survival During the Entire Period of Observation (up to 6 Years).
Time Frame: through study completion; up to 6 years
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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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through study completion; up to 6 years
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Overall Survival
Time Frame: through study completion; up to 6 years
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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. |
through study completion; up to 6 years
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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
Time Frame: Baseline
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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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Baseline
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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
Time Frame: Day 71
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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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Day 71
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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
Time Frame: Day 197
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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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Day 197
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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
Time Frame: Day 365
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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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Day 365
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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
Time Frame: End of Study (month 18)
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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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End of Study (month 18)
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Prof. Jonathan S Cebon, MBBS PhD, Ludwig Institute for Cancer Research
- Principal Investigator: Prof. Martin Gore, MBBS PhD, The Royal Marsden Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LUD2003-009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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