Melanoma
Conditions
Keywords
Phase II, Randomized Controlled Trial, Double-Blind, Cancer Vaccine, NY-ESO-1 protein, human, ISCOMATRIX®, immunological adjuvant
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.
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.
Interventions
BIOLOGICALNY-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).
BIOLOGICALISCOMATRIX® 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).
Sponsors
Institute of Cancer Research, United Kingdom
Ludwig Institute for Cancer Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Relapse-free Survival at 18 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relapse-Free Survival During the Entire Period of Observation (up to 6 Years). | through study completion; 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. |
| Overall Survival | through study completion; up to 6 years | 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 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 | Baseline | 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. |
| Number of Patients With Treatment -Emergent Adverse Events (TEAEs) | 18 months | 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. |
| 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 | Day 197 | 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. |
| 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 | Day 365 | 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. |
| 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 | End of Study (month 18) | 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. |
| 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 | Day 71 | 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. |
Countries
Australia, New Zealand, United Kingdom
Participant flow
Recruitment details
Patients with resected Stage IIc, lIIb, IIIc and IV melanoma who met eligibility requirements were randomized and stratified by stage of disease to receive 4 intramuscular injections of either NY-ESO-1 ISCOMATRIX® or ISCOMATRIX® adjuvant. The first patient was dosed on 27Sep2005 and the last dose was on 27Jun2007.
Pre-assignment details
111 patients were screened and randomized. One patient did not receive study drug. 56 patients were randomized to the NY-ESO-1 ISCOMATRIX® arm and 54 to the ISCOMATRIX® adjuvant arm.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 56 |
| 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). | 54 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Progressive Disease | 24 | 24 |
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Total | ISCOMATRIX® Adjuvant | NY-ESO-1 ISCOMATRIX® Vaccine |
|---|---|---|---|
| Age, Continuous | 53.7 years STANDARD_DEVIATION 13.54 | 53.0 years STANDARD_DEVIATION 13.9 | 54.5 years STANDARD_DEVIATION 13.28 |
| ECOG ECOG PS 0 | 95 Participants | 44 Participants | 51 Participants |
| ECOG ECOG PS 1 | 10 Participants | 8 Participants | 2 Participants |
| ECOG ECOG PS 2 | 0 Participants | 0 Participants | 0 Participants |
| ECOG ECOG PS 3 | 0 Participants | 0 Participants | 0 Participants |
| ECOG ECOG PS 4 | 0 Participants | 0 Participants | 0 Participants |
| ECOG Not Recorded | 5 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 105 Participants | 51 Participants | 54 Participants |
| Race/Ethnicity, Customized White/Caucasian | 110 Participants | 54 Participants | 56 Participants |
| Region of Enrollment Australia | 72 participants | 35 participants | 37 participants |
| Region of Enrollment New Zealand | 6 participants | 4 participants | 2 participants |
| Region of Enrollment United Kingdom | 32 participants | 15 participants | 17 participants |
| Sex: Female, Male Female | 41 Participants | 22 Participants | 19 Participants |
| Sex: Female, Male Male | 69 Participants | 32 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 24 / 56 | 23 / 54 |
| other Total, other adverse events | 54 / 56 | 52 / 54 |
| serious Total, serious adverse events | 10 / 56 | 12 / 54 |
Outcome results
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.
Time frame: 18 months
Population: All randomized patients who received at least one dose of NY-ESO-1 ISCOMATRIX® vaccine or ISCOMATRIX® adjuvant.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NY-ESO-1 ISCOMATRIX® Vaccine | Rate of Relapse-free Survival at 18 Months | Number of patients relapse free at 18 months | 29 Participants |
| NY-ESO-1 ISCOMATRIX® Vaccine | Rate of Relapse-free Survival at 18 Months | Number of patients relapsed at 18 months | 27 Participants |
| ISCOMATRIX® Adjuvant | Rate of Relapse-free Survival at 18 Months | Number of patients relapse free at 18 months | 28 Participants |
| ISCOMATRIX® Adjuvant | Rate of Relapse-free Survival at 18 Months | Number of patients relapsed at 18 months | 26 Participants |
95% CI: [0.532, 1.568]
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.
Time frame: 18 months
Population: All randomized patients who received at least one dose of NY-ESO-1 ISCOMATRIX® vaccine or ISCOMATRIX® adjuvant.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NY-ESO-1 ISCOMATRIX® Vaccine | Number of Patients With Treatment -Emergent Adverse Events (TEAEs) | Number of subjects with at least one TEAE | 54 Participants |
| NY-ESO-1 ISCOMATRIX® Vaccine | Number of Patients With Treatment -Emergent Adverse Events (TEAEs) | Number of subjects with SAE | 10 Participants |
| NY-ESO-1 ISCOMATRIX® Vaccine | Number of Patients With Treatment -Emergent Adverse Events (TEAEs) | Number of subjects discontinued due to TEAE | 2 Participants |
| ISCOMATRIX® Adjuvant | Number of Patients With Treatment -Emergent Adverse Events (TEAEs) | Number of subjects with at least one TEAE | 52 Participants |
| ISCOMATRIX® Adjuvant | Number of Patients With Treatment -Emergent Adverse Events (TEAEs) | Number of subjects with SAE | 12 Participants |
| ISCOMATRIX® Adjuvant | Number of Patients With Treatment -Emergent Adverse Events (TEAEs) | Number of subjects discontinued due to TEAE | 7 Participants |
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NY-ESO-1 ISCOMATRIX® Vaccine | 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 | 1 | 2 Participants |
| NY-ESO-1 ISCOMATRIX® Vaccine | 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 | 3 | 3 Participants |
| NY-ESO-1 ISCOMATRIX® Vaccine | 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 | 2 | 8 Participants |
| NY-ESO-1 ISCOMATRIX® Vaccine | 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 | 4 | 2 Participants |
| NY-ESO-1 ISCOMATRIX® Vaccine | 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 | 0 | 31 Participants |
| ISCOMATRIX® Adjuvant | 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 | 4 | 1 Participants |
| ISCOMATRIX® Adjuvant | 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 | 0 | 32 Participants |
| ISCOMATRIX® Adjuvant | 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 | 1 | 0 Participants |
| ISCOMATRIX® Adjuvant | 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 | 2 | 10 Participants |
| ISCOMATRIX® Adjuvant | 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 | 3 | 2 Participants |
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.
Time frame: End of Study (month 18)
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NY-ESO-1 ISCOMATRIX® Vaccine | 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 | 0 | 0 Participants |
| NY-ESO-1 ISCOMATRIX® Vaccine | 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 | 1 | 2 Participants |
| NY-ESO-1 ISCOMATRIX® Vaccine | 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 | 2 | 6 Participants |
| NY-ESO-1 ISCOMATRIX® Vaccine | 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 | 4 | 3 Participants |
| NY-ESO-1 ISCOMATRIX® Vaccine | 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 | 3 | 26 Participants |
| ISCOMATRIX® Adjuvant | 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 | 3 | 4 Participants |
| ISCOMATRIX® Adjuvant | 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 | 0 | 26 Participants |
| ISCOMATRIX® Adjuvant | 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 | 4 | 0 Participants |
| ISCOMATRIX® Adjuvant | 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 | 1 | 2 Participants |
| ISCOMATRIX® Adjuvant | 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 | 2 | 4 Participants |
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.
Time frame: Day 197
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NY-ESO-1 ISCOMATRIX® Vaccine | 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 | 1 | 0 Participants |
| NY-ESO-1 ISCOMATRIX® Vaccine | 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 | 3 | 21 Participants |
| NY-ESO-1 ISCOMATRIX® Vaccine | 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 | 2 | 3 Participants |
| NY-ESO-1 ISCOMATRIX® Vaccine | 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 | 4 | 10 Participants |
| NY-ESO-1 ISCOMATRIX® Vaccine | 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 | 0 | 0 Participants |
| ISCOMATRIX® Adjuvant | 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 | 4 | 0 Participants |
| ISCOMATRIX® Adjuvant | 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 | 0 | 20 Participants |
| ISCOMATRIX® Adjuvant | 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 | 1 | 0 Participants |
| ISCOMATRIX® Adjuvant | 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 | 2 | 7 Participants |
| ISCOMATRIX® Adjuvant | 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 | 3 | 5 Participants |
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.
Time frame: Day 365
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NY-ESO-1 ISCOMATRIX® Vaccine | 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 | 4 | 1 Participants |
| NY-ESO-1 ISCOMATRIX® Vaccine | 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 | 0 | 0 Participants |
| NY-ESO-1 ISCOMATRIX® Vaccine | 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 | 1 | 1 Participants |
| NY-ESO-1 ISCOMATRIX® Vaccine | 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 | 2 | 3 Participants |
| NY-ESO-1 ISCOMATRIX® Vaccine | 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 | 3 | 22 Participants |
| ISCOMATRIX® Adjuvant | 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 | 3 | 4 Participants |
| ISCOMATRIX® Adjuvant | 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 | 2 | 6 Participants |
| ISCOMATRIX® Adjuvant | 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 | 0 | 19 Participants |
| ISCOMATRIX® Adjuvant | 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 | 4 | 0 Participants |
| ISCOMATRIX® Adjuvant | 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 | 1 | 0 Participants |
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.
Time frame: Day 71
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NY-ESO-1 ISCOMATRIX® Vaccine | 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 | 1 | 0 Participants |
| NY-ESO-1 ISCOMATRIX® Vaccine | 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 | 3 | 32 Participants |
| NY-ESO-1 ISCOMATRIX® Vaccine | 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 | 2 | 2 Participants |
| NY-ESO-1 ISCOMATRIX® Vaccine | 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 | 4 | 9 Participants |
| NY-ESO-1 ISCOMATRIX® Vaccine | 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 | 0 | 0 Participants |
| ISCOMATRIX® Adjuvant | 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 | 4 | 1 Participants |
| ISCOMATRIX® Adjuvant | 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 | 0 | 32 Participants |
| ISCOMATRIX® Adjuvant | 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 | 1 | 2 Participants |
| ISCOMATRIX® Adjuvant | 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 | 2 | 8 Participants |
| ISCOMATRIX® Adjuvant | 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 | 3 | 2 Participants |
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.
Time frame: through study completion; up to 6 years
Population: All randomized patients who received at least one dose of NY-ESO-1 ISCOMATRIX® vaccine or ISCOMATRIX® adjuvant.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NY-ESO-1 ISCOMATRIX® Vaccine | Overall Survival | Number of Patients Dead at last follow-up | 24 Participants |
| NY-ESO-1 ISCOMATRIX® Vaccine | Overall Survival | Number of Patients Alive at last follow-up | 32 Participants |
| ISCOMATRIX® Adjuvant | Overall Survival | Number of Patients Dead at last follow-up | 23 Participants |
| ISCOMATRIX® Adjuvant | Overall Survival | Number of Patients Alive at last follow-up | 31 Participants |
95% CI: [0.514, 1.614]
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.
Time frame: through study completion; up to 6 years
Population: All patients who received at least one dose of NY-ESO-1 ISCOMATRIX® vaccine or ISCOMATRIX® adjuvant.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NY-ESO-1 ISCOMATRIX® Vaccine | Relapse-Free Survival During the Entire Period of Observation (up to 6 Years). | Number of Patients who did not relapse | 23 Participants |
| NY-ESO-1 ISCOMATRIX® Vaccine | Relapse-Free Survival During the Entire Period of Observation (up to 6 Years). | Number of patients who relapsed | 33 Participants |
| ISCOMATRIX® Adjuvant | Relapse-Free Survival During the Entire Period of Observation (up to 6 Years). | Number of Patients who did not relapse | 25 Participants |
| ISCOMATRIX® Adjuvant | Relapse-Free Survival During the Entire Period of Observation (up to 6 Years). | Number of patients who relapsed | 29 Participants |
95% CI: [0.532, 1.455]