Melanoma
Conditions
Keywords
Clinical Trial, Phase 2, Cancer Vaccine, NY-ESO-1 protein, human, ISCOMATRIX, immunological adjuvant, Cyclophosphamide, T-Cells, Regulatory
Brief summary
This was a Phase 2, open-label study of the NY-ESO-1 ISCOMATRIX® (ISCOM) vaccine administered as an intramuscular injection given every 4 weeks to subjects with measurable advanced malignant melanoma. Study objectives included determination of the anticancer activity, cellular and humoral immunogenicity, and safety and tolerability of the NY-ESO-1 ISCOM vaccine administered alone or preceded by a single administration of low-dose cyclophosphamide.
Detailed description
In Cohort 1, 6 subjects were initially vaccinated with the NY-ESO-1 ISCOM vaccine at a dose of 100 µg of the NY-ESO-1 protein + 120 µg of the ISCOM adjuvant. These 6 subjects were monitored for dose-limiting toxicity (DLT) for 7 days after the first vaccination. Upon observation of tolerability (ie, \< 2/6 subjects with DLT), enrollment proceeded to a total accrual of approximately 25 subjects. Subjects received 3 vaccinations administered every 4 weeks (ie, weeks 1, 5, and 9) followed by immunological and clinical response evaluations, with clinical responses categorized according to the Response Evaluation Criteria in Solid Tumors (RECIST). In the absence of disease progression, subjects may have received 3 additional vaccinations administered every 4 weeks, followed by additional vaccinations administered every 12 weeks thereafter until development of disease progression or other criteria for discontinuation. In Cohort 2, subjects received the NY-ESO-1 ISCOM vaccine on the same schedule as described for Cohort 1, but Cohort 2 subjects also received a single intravenous infusion of low-dose cyclophosphamide 1 day prior to each NY-ESO-1 ISCOM vaccination. If responses were observed in 2 of 16 subjects initially treated in Cohort 2, then 9 additional subjects were to be accrued to Cohort 2, for a total potential accrual of 25 subjects.
Interventions
BIOLOGICALNY-ESO-1 ISCOMATRIX® vaccine
NY-ESO-1 ISCOM vaccine (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant) administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
DRUGCyclophosphamide
Cyclophosphamide (300 mg/m\^2) administered as an intravenous injection 1 day prior to each vaccination with NY-ESO-1 ISCOM (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant), which was administered as an intramuscular injection every 4 weeks for 3 doses in every cycle.
Sponsors
Austin Health
Peter MacCallum Cancer Institute
Ludwig Institute for Cancer Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Cohort 1 was enrolled first, in which subjects received the NY-ESO-1 ISCOM vaccine. Enrollment then proceeded to Cohort 2, in which subjects received the NY-ESO-1 ISCOM vaccine and low-dose cyclophosphamide.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Stage IV (metastatic) or unresectable stage III malignant melanoma. 2. Measurable disease using RECIST. 3. No other effective therapy available or appropriate. 4. Expression of NY-ESO-1 or LAGE-1 by immunohistochemistry (IHC) or reverse transcription-polymerase chain reaction (RT-PCR). 5. Expected survival of at least 4 months. 6. Karnofsky performance status of ≥ 70%. 7. Within 3 weeks prior to first administration of study drug, the following laboratory parameters were required to be within the ranges specified: * Hemoglobin ≥ 100 g/L * Platelets ≥ 100 x 10\^9/L * International normalized ratio ≤ 2.0 * Creatinine ≤ 0.2 mmol/L * Bilirubin ≤ 30 mmol/L 8. Age ≥ 18 years. 9. Able and willing to give written informed consent.
Exclusion criteria
1. Other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders, or any condition that in the opinion of the Investigator would have interfered with the ability of the patient to complete all study requirements. 2. Other malignancy within last 3 years, except for treated melanoma or non-melanoma skin cancer or cervical cancer in situ. 3. Known immunodeficiency. 4. Known human immunodeficiency virus positivity. 5. Concomitant systemic treatment with corticosteroids, anti-histaminic drugs, or nonsteroidal anti-inflammatory drugs. Specific cyclooxygenase-2 (COX-2) inhibitors, low-dose aspirin for the prevention of an acute cardiovascular event, and topical or inhaled steroids were permitted. 6. Chemotherapy and/or radiotherapy within 4 weeks prior to study week 1. 7. Other immunotherapy within 4 weeks prior to study week 1. 8. Mental impairment that may have compromised the ability to give informed consent and comply with the requirements of the study. 9. Lack of availability for immunological and clinical follow-up assessment. 10. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment. 11. Pregnancy or breastfeeding. 12. Women of childbearing potential: refusal or inability to use effective means of contraception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Best Overall Tumor Response | Up to 22 months | Tumor responses were evaluated using computed tomography and categorized according to RECIST (version 1.0) at baseline, at week 11, between weeks 23 and 25, and every 12 weeks thereafter. Per RECIST, target lesions are categorized as follows: Complete Response (CR): Disappearance of all target lesions \[no evidence of disease\]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cellular Immunogenicity of the NY-ESO-1 ISCOM Vaccine | Up to 22 months | Blood samples were drawn to measure cellular response at pretreatment and weeks 3, 7, 11, between weeks 23 and 25, week 33, and every 12 weeks thereafter. Cellular immunity included an assay for gamma interferon-producing T cells and enumeration of NY-ESO-1b-specific T cells, detected by fluorescent labeled human leukocyte antigen (HLA)-A2 tetramers carrying the NY-ESO-1b peptide, expressed as percent positive staining of CD4+ and CD8+ T cells. Data are presented for CD4+ and CD8+ T-cell responses (not mutually exclusive) that were pre-existing at baseline (BL) or presented at any time post-BL. |
| Post-Vaccination Delayed-type Hypersensitivity (DTH) Reactions | Up to 22 months | NY-ESO-1-specific DTH was measured by intradermal injection with the full-length NY-ESO-1 protein, NY-ESO-1b peptide, and NY-ESO-1 DP4 peptide at pretreatment, week 11, and between week 23 and 25. DTH reactions (eg, local skin irritation) were evaluated 2 days after DTH injections. Data presented are based on injections with the full-length peptide, as these data are considered to be representative of the comprehensive DTH results. |
| Humoral Immunogenicity of the NY-ESO-1 ISCOM Vaccine | Up to 22 months | Blood samples were drawn to measure humoral immunologic response at pretreatment and weeks 3, 7, 11, 33, and every 12 weeks thereafter. Humoral immunity was assessed by measurement of antibodies to NY-ESO-1 by enzyme-linked immunosorbent assay (ELISA). Data are presented according to baseline (BL) NY-ESO-1 antibody positivity and the time to seroconversion, if applicable. |
| Number of Subjects With Treatment-emergent Adverse Events | Up to 22 months | Toxicity was graded in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (version 3.0). Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the study period. Dose-limiting toxicity was defined as any treatment-related grade 4 toxicity or any grade 3 toxicity, excluding grade 3 skin necrosis at the site of the delayed-type hypersensitivity reaction, fever, or asymptomatic hyperglycemia that improved to baseline within 3 weeks of onset. |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: NY-ESO-1 ISCOM Subjects received the NY-ESO-1 ISCOM vaccine (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant) administered as an intramuscular injection every 4 weeks for 3 doses in every cycle. | 27 |
| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM Subjects received cyclophosphamide (300 mg/m\^2) administered as an intravenous injection 1 day prior to each vaccination with NY-ESO-1 ISCOM (100 μg of the NY-ESO-1 protein formulated with 120 μg of ISCOM adjuvant), which was administered as an intramuscular injection every 4 weeks for 3 doses in every cycle. | 19 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Completion Status Unknown | 1 | 0 |
| Overall Study | Disease Progression Requiring Therapy | 6 | 6 |
| Overall Study | Drug Supply Issue | 1 | 0 |
| Overall Study | Reason Unknown | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | Total | Cohort 1: NY-ESO-1 ISCOM |
|---|---|---|---|
| Age, Continuous | 61.0 years | 61.0 years | 61.0 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 19 Participants | 46 Participants | 27 Participants |
| Karnofsky Performance Status 100 | 10 Participants | 28 Participants | 18 Participants |
| Karnofsky Performance Status 70 | 0 Participants | 2 Participants | 2 Participants |
| Karnofsky Performance Status 80 | 1 Participants | 4 Participants | 3 Participants |
| Karnofsky Performance Status 90 | 8 Participants | 12 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 6 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 39 Participants | 26 Participants |
| Region of Enrollment Australia | 19 Participants | 46 Participants | 27 Participants |
| Sex: Female, Male Female | 7 Participants | 20 Participants | 13 Participants |
| Sex: Female, Male Male | 12 Participants | 26 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 19 |
| other Total, other adverse events | 27 / 27 | 19 / 19 |
| serious Total, serious adverse events | 5 / 27 | 7 / 19 |
Outcome results
Primary
Number of Subjects With Best Overall Tumor Response
Tumor responses were evaluated using computed tomography and categorized according to RECIST (version 1.0) at baseline, at week 11, between weeks 23 and 25, and every 12 weeks thereafter. Per RECIST, target lesions are categorized as follows: Complete Response (CR): Disappearance of all target lesions \[no evidence of disease\]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.
Time frame: Up to 22 months
Population: Subjects with data available from at least 1 post-baseline response assessment.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: NY-ESO-1 ISCOM | Number of Subjects With Best Overall Tumor Response | Partial response | 1 Participants |
| Cohort 1: NY-ESO-1 ISCOM | Number of Subjects With Best Overall Tumor Response | Stable disease | 12 Participants |
| Cohort 1: NY-ESO-1 ISCOM | Number of Subjects With Best Overall Tumor Response | Progressive disease | 12 Participants |
| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | Number of Subjects With Best Overall Tumor Response | Partial response | 1 Participants |
| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | Number of Subjects With Best Overall Tumor Response | Stable disease | 4 Participants |
| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | Number of Subjects With Best Overall Tumor Response | Progressive disease | 14 Participants |
Secondary
Cellular Immunogenicity of the NY-ESO-1 ISCOM Vaccine
Blood samples were drawn to measure cellular response at pretreatment and weeks 3, 7, 11, between weeks 23 and 25, week 33, and every 12 weeks thereafter. Cellular immunity included an assay for gamma interferon-producing T cells and enumeration of NY-ESO-1b-specific T cells, detected by fluorescent labeled human leukocyte antigen (HLA)-A2 tetramers carrying the NY-ESO-1b peptide, expressed as percent positive staining of CD4+ and CD8+ T cells. Data are presented for CD4+ and CD8+ T-cell responses (not mutually exclusive) that were pre-existing at baseline (BL) or presented at any time post-BL.
Time frame: Up to 22 months
Population: Subjects with available results from the evaluation of T-cell responses in peripheral blood.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: NY-ESO-1 ISCOM | Cellular Immunogenicity of the NY-ESO-1 ISCOM Vaccine | New CD4+ T-cell Response Post-BL | 6 participants |
| Cohort 1: NY-ESO-1 ISCOM | Cellular Immunogenicity of the NY-ESO-1 ISCOM Vaccine | New CD8+ T-cell Response Post-BL | 5 participants |
| Cohort 1: NY-ESO-1 ISCOM | Cellular Immunogenicity of the NY-ESO-1 ISCOM Vaccine | CD8+ T-cell Response at BL and Post-BL | 12 participants |
| Cohort 1: NY-ESO-1 ISCOM | Cellular Immunogenicity of the NY-ESO-1 ISCOM Vaccine | No CD4+ or CD8+ T-cell Response | 6 participants |
| Cohort 1: NY-ESO-1 ISCOM | Cellular Immunogenicity of the NY-ESO-1 ISCOM Vaccine | CD4+ T-cell Response at BL and Post-BL | 4 participants |
| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | Cellular Immunogenicity of the NY-ESO-1 ISCOM Vaccine | No CD4+ or CD8+ T-cell Response | 3 participants |
| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | Cellular Immunogenicity of the NY-ESO-1 ISCOM Vaccine | CD4+ T-cell Response at BL and Post-BL | 3 participants |
| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | Cellular Immunogenicity of the NY-ESO-1 ISCOM Vaccine | New CD4+ T-cell Response Post-BL | 7 participants |
| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | Cellular Immunogenicity of the NY-ESO-1 ISCOM Vaccine | CD8+ T-cell Response at BL and Post-BL | 3 participants |
| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | Cellular Immunogenicity of the NY-ESO-1 ISCOM Vaccine | New CD8+ T-cell Response Post-BL | 1 participants |
Secondary
Humoral Immunogenicity of the NY-ESO-1 ISCOM Vaccine
Blood samples were drawn to measure humoral immunologic response at pretreatment and weeks 3, 7, 11, 33, and every 12 weeks thereafter. Humoral immunity was assessed by measurement of antibodies to NY-ESO-1 by enzyme-linked immunosorbent assay (ELISA). Data are presented according to baseline (BL) NY-ESO-1 antibody positivity and the time to seroconversion, if applicable.
Time frame: Up to 22 months
Population: Subjects with available measurement of baseline and post-baseline positivity for NY-ESO-1 antibodies.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: NY-ESO-1 ISCOM | Humoral Immunogenicity of the NY-ESO-1 ISCOM Vaccine | NY-ESO-1 (+) at BL and Post-BL | 7 Participants |
| Cohort 1: NY-ESO-1 ISCOM | Humoral Immunogenicity of the NY-ESO-1 ISCOM Vaccine | NY-ESO-1 (-) at BL, converted to (+) Post-BL | 19 Participants |
| Cohort 1: NY-ESO-1 ISCOM | Humoral Immunogenicity of the NY-ESO-1 ISCOM Vaccine | NY-ESO-1 (-) at BL and Post-BL | 1 Participants |
| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | Humoral Immunogenicity of the NY-ESO-1 ISCOM Vaccine | NY-ESO-1 (+) at BL and Post-BL | 2 Participants |
| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | Humoral Immunogenicity of the NY-ESO-1 ISCOM Vaccine | NY-ESO-1 (-) at BL, converted to (+) Post-BL | 8 Participants |
| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | Humoral Immunogenicity of the NY-ESO-1 ISCOM Vaccine | NY-ESO-1 (-) at BL and Post-BL | 5 Participants |
Secondary
Number of Subjects With Treatment-emergent Adverse Events
Toxicity was graded in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (version 3.0). Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the study period. Dose-limiting toxicity was defined as any treatment-related grade 4 toxicity or any grade 3 toxicity, excluding grade 3 skin necrosis at the site of the delayed-type hypersensitivity reaction, fever, or asymptomatic hyperglycemia that improved to baseline within 3 weeks of onset.
Time frame: Up to 22 months
Population: The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: NY-ESO-1 ISCOM | Number of Subjects With Treatment-emergent Adverse Events | Any TEAE | 27 participants |
| Cohort 1: NY-ESO-1 ISCOM | Number of Subjects With Treatment-emergent Adverse Events | Serious TEAE | 5 participants |
| Cohort 1: NY-ESO-1 ISCOM | Number of Subjects With Treatment-emergent Adverse Events | Maximum Grade 4 TEAE | 1 participants |
| Cohort 1: NY-ESO-1 ISCOM | Number of Subjects With Treatment-emergent Adverse Events | Death | 0 participants |
| Cohort 1: NY-ESO-1 ISCOM | Number of Subjects With Treatment-emergent Adverse Events | Maximum Grade 3 TEAE | 4 participants |
| Cohort 1: NY-ESO-1 ISCOM | Number of Subjects With Treatment-emergent Adverse Events | TEAE Leading to Discontinuation | 2 participants |
| Cohort 1: NY-ESO-1 ISCOM | Number of Subjects With Treatment-emergent Adverse Events | Treatment-related TEAE | 26 participants |
| Cohort 1: NY-ESO-1 ISCOM | Number of Subjects With Treatment-emergent Adverse Events | Dose-limiting Toxicity | 0 participants |
| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | Number of Subjects With Treatment-emergent Adverse Events | Treatment-related TEAE | 19 participants |
| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | Number of Subjects With Treatment-emergent Adverse Events | Dose-limiting Toxicity | 0 participants |
| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | Number of Subjects With Treatment-emergent Adverse Events | Maximum Grade 3 TEAE | 9 participants |
| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | Number of Subjects With Treatment-emergent Adverse Events | Maximum Grade 4 TEAE | 1 participants |
| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | Number of Subjects With Treatment-emergent Adverse Events | Any TEAE | 19 participants |
| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | Number of Subjects With Treatment-emergent Adverse Events | Serious TEAE | 7 participants |
| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | Number of Subjects With Treatment-emergent Adverse Events | Death | 0 participants |
| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | Number of Subjects With Treatment-emergent Adverse Events | TEAE Leading to Discontinuation | 1 participants |
Secondary
Post-Vaccination Delayed-type Hypersensitivity (DTH) Reactions
NY-ESO-1-specific DTH was measured by intradermal injection with the full-length NY-ESO-1 protein, NY-ESO-1b peptide, and NY-ESO-1 DP4 peptide at pretreatment, week 11, and between week 23 and 25. DTH reactions (eg, local skin irritation) were evaluated 2 days after DTH injections. Data presented are based on injections with the full-length peptide, as these data are considered to be representative of the comprehensive DTH results.
Time frame: Up to 22 months
Population: Subjects who underwent DTH testing with available DTH reaction evaluation(s).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: NY-ESO-1 ISCOM | Post-Vaccination Delayed-type Hypersensitivity (DTH) Reactions | Reaction at Pretreatment and Week 11 | 2 Participants |
| Cohort 1: NY-ESO-1 ISCOM | Post-Vaccination Delayed-type Hypersensitivity (DTH) Reactions | Reaction at Pretreatment and Week 23 | 1 Participants |
| Cohort 1: NY-ESO-1 ISCOM | Post-Vaccination Delayed-type Hypersensitivity (DTH) Reactions | Reaction at Pretreatment, No Reaction On Study | 0 Participants |
| Cohort 1: NY-ESO-1 ISCOM | Post-Vaccination Delayed-type Hypersensitivity (DTH) Reactions | Reaction at Pretreatment, No On Study DTH Results | 0 Participants |
| Cohort 1: NY-ESO-1 ISCOM | Post-Vaccination Delayed-type Hypersensitivity (DTH) Reactions | No Reaction Pretreatment , Reaction at Week 11 | 6 Participants |
| Cohort 1: NY-ESO-1 ISCOM | Post-Vaccination Delayed-type Hypersensitivity (DTH) Reactions | No Reaction Pretreatment , Reaction at Week 23 | 0 Participants |
| Cohort 1: NY-ESO-1 ISCOM | Post-Vaccination Delayed-type Hypersensitivity (DTH) Reactions | No Reaction Pretreatment or on Study | 16 Participants |
| Cohort 1: NY-ESO-1 ISCOM | Post-Vaccination Delayed-type Hypersensitivity (DTH) Reactions | No Reaction Pretreatment, No On Study DTH Results | 0 Participants |
| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | Post-Vaccination Delayed-type Hypersensitivity (DTH) Reactions | No Reaction Pretreatment, No On Study DTH Results | 3 Participants |
| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | Post-Vaccination Delayed-type Hypersensitivity (DTH) Reactions | Reaction at Pretreatment and Week 11 | 3 Participants |
| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | Post-Vaccination Delayed-type Hypersensitivity (DTH) Reactions | No Reaction Pretreatment , Reaction at Week 11 | 4 Participants |
| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | Post-Vaccination Delayed-type Hypersensitivity (DTH) Reactions | Reaction at Pretreatment and Week 23 | 0 Participants |
| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | Post-Vaccination Delayed-type Hypersensitivity (DTH) Reactions | No Reaction Pretreatment or on Study | 6 Participants |
| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | Post-Vaccination Delayed-type Hypersensitivity (DTH) Reactions | Reaction at Pretreatment, No Reaction On Study | 1 Participants |
| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | Post-Vaccination Delayed-type Hypersensitivity (DTH) Reactions | No Reaction Pretreatment , Reaction at Week 23 | 3 Participants |
| Cohort 2: Cyclophosphamide + NY-ESO-1 ISCOM | Post-Vaccination Delayed-type Hypersensitivity (DTH) Reactions | Reaction at Pretreatment, No On Study DTH Results | 1 Participants |