Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Vaccines

Adjuvants, Immunologic

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).

NY-ESO-1 ISCOMATRIX®

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).

ISCOMATRIX® adjuvant

Prof. Jonathan S Cebon, MBBS PhD

Prof. Martin Gore, MBBS PhD

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.

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 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

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.

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.

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.

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.

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.

Institute of Cancer Research, United Kingdom

Ludwig Institute for Cancer Research

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 documented from the time informed consent was 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.

100 μg of NY-ESO-1 protein formulated with 120 μg of ISCOMATRIX® adjuvant. Each patient received four intramuscular injections of NY-ESO-1 ISCOMATRIX® vaccine. The first three doses were given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection was given at month 6 (day 183 ± 3 days).

NY-ESO-1 ISCOMATRIX® Vaccine

120 μg of ISCOMATRIX® adjuvant. Each patient received four intramuscular injections of ISCOMATRIX® adjuvant. The first three doses were given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection was given at month 6 (day 183 ± 3 days).

ISCOMATRIX® Adjuvant

100 μg of NY-ESO-1 protein formulated with 120 μg of ISCOMATRIX® adjuvant.

Each patient received four intramuscular injections of NY-ESO-1 ISCOMATRIX® vaccine. The first three doses were given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection was given at month 6 (day 183 ± 3 days).

120 μg of ISCOMATRIX® adjuvant.

Each patient received four intramuscular injections of ISCOMATRIX® adjuvant. The first three doses were given at four-week intervals, days 1, 29, and 57, (± 3 days of scheduled date). The fourth injection was given at month 6 (day 183 ± 3 days).

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

White/Caucasian

Race/Ethnicity, Customized

New Zealand

United Kingdom

Australia

Region of Enrollment

PS 0 = Fully active, able to carry on all pre-disease performance without restriction; PS 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; PS 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; PS 3 = Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; PS 4 = Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; PS 5 = Dead

ECOG

All patients randomized and received NY-ESO-1 ISCOMATRIX® Vaccine or ISCOMATRIX® adjuvant.

Jonathan Skipper PhD

All randomized patients who received at least one dose of NY-ESO-1 ISCOMATRIX® vaccine or ISCOMATRIX® adjuvant.

Rate of Relapse-free Survival at 18 Months

Number of subjects with at least one TEAE

Number of subjects with SAE

Number of subjects discontinued due to TEAE

Number of Patients With Treatment -Emergent Adverse Events (TEAEs)

All patients who received at least one dose of NY-ESO-1 ISCOMATRIX® vaccine or ISCOMATRIX® adjuvant.

Relapse-Free Survival During the Entire Period of Observation (up to 6 Years).

Overall Survival

All randomized patients who received at least one dose of NY-ESO-1 ISCOMATRIX® vaccine or ISCOMATRIX® adjuvant and provided blood samples for analysis at the required time. Patients who discontinued the study prior to the scheduled day were not included at the later timepoints.

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

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

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of NY-ESO-1 ISCOMATRIX® in Patients With High-risk, Resected Melanoma	NCT00199901	Melanoma	NY-ESO-1 ISCOMA... ISCOMATRIX® adj...	18 Years -	Ludwig Institute for Cancer Research
Study of NY-ESO-1 ISCOMATRIX® in Patients With High-risk, Resected Melanoma	NCT00199901	Melanoma	NY-ESO-1 ISCOMA... ISCOMATRIX® adj...	18 Years -	Ludwig Institute for Cancer Research
Study of NY-ESO-1 ISCOMATRIX® in Patients With High-risk, Resected Melanoma	NCT00199901	Melanoma	NY-ESO-1 ISCOMA... ISCOMATRIX® adj...	18 Years -	Ludwig Institute for Cancer Research

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