| Primary | Rate of Relapse-free Survival at 18 Months | 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. | All randomized patients who received at least one dose of NY-ESO-1 ISCOMATRIX® vaccine or ISCOMATRIX® adjuvant. | Posted | | Count of Participants | | Participants | | 18 months | | | | ID | Title | Description |
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| OG000 | NY-ESO-1 ISCOMATRIX® Vaccine | 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). | | OG001 | ISCOMATRIX® Adjuvant | 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). |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| Number of patients relapse free at 18 months | | | Number of patients relapsed at 18 months | |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | | | | | Hazard Ratio (HR) | 0.913 | | | 2-Sided | 95 | 0.532 | 1.568 | | | | | Superiority | | |
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| Secondary | Number of Patients With Treatment -Emergent Adverse Events (TEAEs) | 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. | All randomized patients who received at least one dose of NY-ESO-1 ISCOMATRIX® vaccine or ISCOMATRIX® adjuvant. | Posted | | Count of Participants | | Participants | | 18 months | | | | ID | Title | Description |
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| OG000 | NY-ESO-1 ISCOMATRIX® Vaccine | 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). | | OG001 | ISCOMATRIX® Adjuvant | 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). |
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| Secondary | Relapse-Free Survival During the Entire Period of Observation (up to 6 Years). | 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. | All patients who received at least one dose of NY-ESO-1 ISCOMATRIX® vaccine or ISCOMATRIX® adjuvant. | Posted | | Count of Participants | | Participants | | through study completion; up to 6 years | | | | ID | Title | Description |
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| OG000 | NY-ESO-1 ISCOMATRIX® Vaccine | 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). | | OG001 | ISCOMATRIX® Adjuvant | 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). |
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| Secondary | Overall Survival | 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. | All randomized patients who received at least one dose of NY-ESO-1 ISCOMATRIX® vaccine or ISCOMATRIX® adjuvant. | Posted | | Count of Participants | | Participants | | through study completion; up to 6 years | | | | ID | Title | Description |
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| OG000 | NY-ESO-1 ISCOMATRIX® Vaccine | 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). | | OG001 | ISCOMATRIX® Adjuvant | 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). |
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| Secondary | 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-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. | 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. | Posted | | Count of Participants | | Participants | | Baseline | | | | ID | Title | Description |
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| OG000 | NY-ESO-1 ISCOMATRIX® Vaccine | 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). | | OG001 | ISCOMATRIX® Adjuvant | 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). |
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| Secondary | 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-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. | 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. | Posted | | Count of Participants | | Participants | | Day 71 | | | | ID | Title | Description |
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| OG000 | NY-ESO-1 ISCOMATRIX® Vaccine | 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). | | OG001 | ISCOMATRIX® Adjuvant | 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). |
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| Secondary | 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-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. | 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. | Posted | | Count of Participants | | Participants | | Day 197 | | | | ID | Title | Description |
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| OG000 | NY-ESO-1 ISCOMATRIX® Vaccine | 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). | | OG001 | ISCOMATRIX® Adjuvant | 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). |
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| Secondary | 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-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. | 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. | Posted | | Count of Participants | | Participants | | Day 365 | | | | ID | Title | Description |
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| OG000 | NY-ESO-1 ISCOMATRIX® Vaccine | 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). | | OG001 | ISCOMATRIX® Adjuvant | 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). |
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| Secondary | 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 | 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. | 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. | Posted | | Count of Participants | | Participants | | End of Study (month 18) | | | | ID | Title | Description |
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| OG000 | NY-ESO-1 ISCOMATRIX® Vaccine | 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). | | OG001 | ISCOMATRIX® Adjuvant | 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). |
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