Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
Conditions
Keywords
NY-ESO-1 OLP4, Ovarian Cancer, Cancer Vaccine
Brief summary
This was a Phase 1, open-label study of repeated vaccination with NY-ESO-1 overlapping peptides (OLP4) with or without the immunoadjuvants Montanide and polyinosinic-polycytidylic acid - poly-L-lysine carboxymethylcellulose (poly-ICLC) administered every 3 weeks for a total of 5 vaccinations in subjects with epithelial ovarian, fallopian tube, or primary peritoneal cancer in second or third clinical remission. Study objectives included determination of the safety and immunogenicity following vaccination.
Detailed description
Subjects received NY-ESO-1 OLP4 by subcutaneous injection once every 3 weeks (Weeks 1, 4, 7, 10, and 13) for a total of 5 vaccinations. Subjects were assigned sequentially to 1 of 3 dosing cohorts: Cohort 1: received NY-ESO-1 OLP4 alone; Cohort 2: received NY-ESO-1 OLP4 in combination with Montanide; Cohort 3: received NY-ESO-1 OLP4 in combination with Montanide and Poly-ICLC. Enrollment into each subsequent dosing cohort was dependent on a dose-limiting toxicity (DLT) rate of \<33% in the preceding cohort. No dose escalation was planned. Subjects were observed by study staff for up to 30 minutes following each vaccination. Immunologic assessments were performed prior to the first vaccination and 3 weeks after each vaccination. Toxicity assessments were performed with each vaccination and 3 weeks after the completion of therapy (ie, the final study visit was Week 16). Immunologic assessments included measurement of the anti-NY-ESO-1 antibody by enzyme-linked immunsorbent assay (ELISA), detection of CD-4 and CD-8 cellular responses by tetramer and enzyme-linked immunosorbent spot assay (ELISPOT), and delayed-type hypersensitivity (DTH).
Interventions
BIOLOGICALNY-ESO-1 OLP4
1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of 5% dextrose in water (D5W) and administered subcutaneously as a single injection.
BIOLOGICALNY-ESO-1 OLP4 + Montanide
1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W, mixed with 0.5 mL of Montanide, and administered subcutaneously as a single injection.
BIOLOGICALNY-ESO-1 OLP4 + Montanide + Poly-ICLC
1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) and 1.4 mg of poly-ICLC were emulsified in 1.0 mL of Montanide and administered subcutaneously as two injections.
Sponsors
Memorial Sloan Kettering Cancer Center
Ludwig Institute for Cancer Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically documented epithelial carcinoma arising in the ovary, fallopian tube, or peritoneum, stage II to IV at diagnosis, and post-initial cytoreductive surgery and chemotherapy with at least one platinum-based chemotherapy regimen. 2. In second or third stable complete clinical remission, defined as a) stable cancer antigen (CA)-125 \< 35 U/ml (defined as CA-125 that had not doubled from the post chemotherapy nadir), b) unremarkable physical examination, and c) no definite evidence of disease by computed tomography (CT) of the abdomen and pelvis. Lymph nodes and/or soft tissue abnormalities ≤ 1.0 cm that are often present in the pelvis were not considered definite evidence of disease. 3. Expected survival of at least 4 months. 4. Karnofsky performance scale ≥ 70%. 5. Laboratory values within the following limits: * Hemoglobin ≥ 10.0 g/dL * Neutrophil count ≥ 1.5 x 10\^9/L * Platelet count ≥ 80 x 10\^9/L * Serum creatinine ≤ 2.0 mg/dL * Serum bilirubin ≤ 2.5 x institutional upper limit of normal (ULN) * aspartate aminotransferase/alanine aminotransferase ≤ 2.5 x institutional ULN 6. Age ≥ 18 years. 7. ≥ 4 weeks since completion of prior cytotoxic chemotherapy. 8. Able and willing to give valid written informed consent
Exclusion criteria
1. Clinically significant heart disease (New York Heart Association Class III or IV). 2. Serious intercurrent illness, eg, serious infections requiring prolonged parenteral antibiotics or bleeding disorders requiring hospitalization. 3. Positive stool guaiac excluding hemorrhoids. 4. Known autoimmune disease (ie, rheumatoid arthritis, ulcerative colitis, etc); or immune deficiency (human immunodeficiency virus, hypogammaglobulinemia); or known active infections with Hepatitis B or Hepatitis C; or receipt of immunosuppressive drugs such as systemic corticosteroids or cyclosporin, etc. 5. Other malignancy within 3 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ. 6. History of previous severe allergic reactions to vaccines or unknown allergens. 7. Mental impairment that may have compromised the ability to give informed consent and comply with the requirements of the study. 8. Lack of availability for immunological and clinical follow-up assessments. 9. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent. 10. Pregnancy or breast-feeding. 11. Women of childbearing potential: Refusal or inability to use effective means of contraception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overview of Treatment-emergent Adverse Events (TEAEs) | Continuously for up to 16 weeks | Analysis of TEAEs reported from clinical laboratory tests, physical examinations, and vital signs from pre-treatment through 3 weeks after the last dose of study treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Detectable Serum Immunoglobulin G (IgG) Antibody Titers Against NY-ESO-1 Up to 16 Weeks Post-Baseline | Screening and Weeks 4, 7, 10, 13, and 16 | Blood samples were drawn to measure immunologic response at Screening and Weeks 4, 7, 10, 13, and 16. Specific antibodies against NY-ESO-1 were measured by enzyme-linked immunosorbent assay (ELISA). |
| Number of Patients With Detectable CD8+ and CD4+ T-cell Responses Up to 16 Weeks Post-Baseline | Screening and Weeks 4, 7, 10, 13, and 16 | Blood samples were drawn to measure immunologic response at Screening and Weeks 4, 7, 10, 13, and 16. NY-ESO-1-specific CD8+ and CD4+ T-cell reactivity was measured by tetramer analysis (in human leukocyte antigen \[HLA\] 0201\* patients). Interferon gamma (IFN-γ) release by T cells was measured by the enzyme-linked immunospot (ELISPOT) assay. A subject was considered to have experienced a T-cell response if IFN-γ spots were detectable (\>50 spots) by ELISPOT of 50,000 CD8+ and CD4+ T cells following pre-sensitization with a pool of 20-mer OLP covering all of NY-ESO-1 and tested against Epstein-Barr virus-transformed B cells pulsed with 3 subpools of these peptides. |
| Number of Patients With Delayed-type Hypersensitivity (DTH) Reactions (Induration and Redness) to NY-ESO-1 OLP4 at Screening and Week 16 | Screening and Week 16 | NY-ESO-1-specific DTH was measured by skin tests at Screening and again at Week 16. NY-ESO-1 OLP4 (40 µg in 0.1 mL D5W) was injected intradermally, with DTH reactions read 48 hours after injection. |
| Cancer Antigen (CA)-125 Levels Up to 16 Weeks Post-Baseline | Screening, Week 7, and Week 16 | Serum CA-125 was measured at Screening, Week 7, and Week 16. Stable CA-125 at baseline was \< 35 U/mL (defined as CA-125 that had not doubled from the post chemotherapy nadir). |
| Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline | Screening and every 2 months up to Week 16 | Radiographic imaging (computed tomography of the abdomen and pelvis) was obtained at Screening and every 2 months during the study, and at unscheduled time points if any clinical symptoms/examination findings warranted further evaluation or if serum CA-125 rose to \> 70 U/mL (confirmed by repeat value). Subjects may have had more than 1 location of disease. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) once every 3 weeks for a total of 5 vaccinations.
1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W and administered subcutaneously as a single injection. | 4 |
| Cohort 2 Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 VG once every 3 weeks for a total of 5 vaccinations.
1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W, mixed with 0.5 mL of Montanide, and administered subcutaneously as a single injection. | 13 |
| Cohort 3 Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 VG and poly-ICLC once every 3 weeks for a total of 5 vaccinations.
1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) and 1.4 mg of poly-ICLC were emulsified in 1.0 mL of Montanide and administered subcutaneously as two injections. | 11 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 1 |
| Overall Study | Progressive Disease | 1 | 2 | 1 |
| Overall Study | Subject Non-compliance | 0 | 0 | 1 |
| Overall Study | Unrelated Medical Illness/Complication | 0 | 2 | 0 |
| Overall Study | Vaccination Suspended | 0 | 0 | 3 |
Baseline characteristics
| Characteristic | Cohort 1 | Cohort 2 | Cohort 3 | Total |
|---|---|---|---|---|
| Age, Continuous | 56.8 years STANDARD_DEVIATION 10.7 | 58.6 years STANDARD_DEVIATION 7.7 | 57.1 years STANDARD_DEVIATION 9.5 | 57.8 years STANDARD_DEVIATION 8.5 |
| Body Mass Index | 23.6 kg/m^2 STANDARD_DEVIATION 4.8 | 29.1 kg/m^2 STANDARD_DEVIATION 8.1 | 26.5 kg/m^2 STANDARD_DEVIATION 6.6 | 27.3 kg/m^2 STANDARD_DEVIATION 7.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 13 Participants | 11 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 13 Participants | 10 Participants | 27 Participants |
| Region of Enrollment United States | 4 Participants | 13 Participants | 11 Participants | 28 Participants |
| Sex: Female, Male Female | 4 Participants | 13 Participants | 11 Participants | 28 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 13 | 0 / 11 |
| other Total, other adverse events | 3 / 4 | 13 / 13 | 11 / 11 |
| serious Total, serious adverse events | 0 / 4 | 1 / 13 | 0 / 11 |
Outcome results
Primary
Overview of Treatment-emergent Adverse Events (TEAEs)
Analysis of TEAEs reported from clinical laboratory tests, physical examinations, and vital signs from pre-treatment through 3 weeks after the last dose of study treatment.
Time frame: Continuously for up to 16 weeks
Population: The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Overview of Treatment-emergent Adverse Events (TEAEs) | Any TEAE | 3 Participants |
| Cohort 1 | Overview of Treatment-emergent Adverse Events (TEAEs) | Treatment-related TEAE | 2 Participants |
| Cohort 1 | Overview of Treatment-emergent Adverse Events (TEAEs) | TEAE Leading to Discontinuation | 0 Participants |
| Cohort 1 | Overview of Treatment-emergent Adverse Events (TEAEs) | Dose-limiting toxicity | 0 Participants |
| Cohort 1 | Overview of Treatment-emergent Adverse Events (TEAEs) | Serious TEAE | 0 Participants |
| Cohort 1 | Overview of Treatment-emergent Adverse Events (TEAEs) | Death | 0 Participants |
| Cohort 2 | Overview of Treatment-emergent Adverse Events (TEAEs) | Death | 0 Participants |
| Cohort 2 | Overview of Treatment-emergent Adverse Events (TEAEs) | Any TEAE | 13 Participants |
| Cohort 2 | Overview of Treatment-emergent Adverse Events (TEAEs) | Dose-limiting toxicity | 1 Participants |
| Cohort 2 | Overview of Treatment-emergent Adverse Events (TEAEs) | Serious TEAE | 1 Participants |
| Cohort 2 | Overview of Treatment-emergent Adverse Events (TEAEs) | Treatment-related TEAE | 12 Participants |
| Cohort 2 | Overview of Treatment-emergent Adverse Events (TEAEs) | TEAE Leading to Discontinuation | 3 Participants |
| Cohort 3 | Overview of Treatment-emergent Adverse Events (TEAEs) | Treatment-related TEAE | 11 Participants |
| Cohort 3 | Overview of Treatment-emergent Adverse Events (TEAEs) | TEAE Leading to Discontinuation | 1 Participants |
| Cohort 3 | Overview of Treatment-emergent Adverse Events (TEAEs) | Death | 0 Participants |
| Cohort 3 | Overview of Treatment-emergent Adverse Events (TEAEs) | Dose-limiting toxicity | 0 Participants |
| Cohort 3 | Overview of Treatment-emergent Adverse Events (TEAEs) | Any TEAE | 11 Participants |
| Cohort 3 | Overview of Treatment-emergent Adverse Events (TEAEs) | Serious TEAE | 0 Participants |
Secondary
Cancer Antigen (CA)-125 Levels Up to 16 Weeks Post-Baseline
Serum CA-125 was measured at Screening, Week 7, and Week 16. Stable CA-125 at baseline was \< 35 U/mL (defined as CA-125 that had not doubled from the post chemotherapy nadir).
Time frame: Screening, Week 7, and Week 16
Population: The Tumor Response Analysis Set comprises all subjects who had a given post-baseline efficacy measurement performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Cancer Antigen (CA)-125 Levels Up to 16 Weeks Post-Baseline | Week 7 | 29.5 U/mL | Standard Deviation 44.3 |
| Cohort 1 | Cancer Antigen (CA)-125 Levels Up to 16 Weeks Post-Baseline | Screening | 14.0 U/mL | Standard Deviation 12.7 |
| Cohort 1 | Cancer Antigen (CA)-125 Levels Up to 16 Weeks Post-Baseline | Week 16 | 8.0 U/mL | Standard Deviation 1 |
| Cohort 2 | Cancer Antigen (CA)-125 Levels Up to 16 Weeks Post-Baseline | Week 7 | 13.8 U/mL | Standard Deviation 12.5 |
| Cohort 2 | Cancer Antigen (CA)-125 Levels Up to 16 Weeks Post-Baseline | Screening | 8.5 U/mL | Standard Deviation 5.3 |
| Cohort 2 | Cancer Antigen (CA)-125 Levels Up to 16 Weeks Post-Baseline | Week 16 | 12.9 U/mL | Standard Deviation 9.7 |
| Cohort 3 | Cancer Antigen (CA)-125 Levels Up to 16 Weeks Post-Baseline | Screening | 10.9 U/mL | Standard Deviation 4.4 |
| Cohort 3 | Cancer Antigen (CA)-125 Levels Up to 16 Weeks Post-Baseline | Week 16 | 35.1 U/mL | Standard Deviation 66 |
| Cohort 3 | Cancer Antigen (CA)-125 Levels Up to 16 Weeks Post-Baseline | Week 7 | 21.3 U/mL | Standard Deviation 25.8 |
Secondary
Number of Patients With Delayed-type Hypersensitivity (DTH) Reactions (Induration and Redness) to NY-ESO-1 OLP4 at Screening and Week 16
NY-ESO-1-specific DTH was measured by skin tests at Screening and again at Week 16. NY-ESO-1 OLP4 (40 µg in 0.1 mL D5W) was injected intradermally, with DTH reactions read 48 hours after injection.
Time frame: Screening and Week 16
Population: The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Number of Patients With Delayed-type Hypersensitivity (DTH) Reactions (Induration and Redness) to NY-ESO-1 OLP4 at Screening and Week 16 | Presence of Induration at Screening | 0 Participants |
| Cohort 1 | Number of Patients With Delayed-type Hypersensitivity (DTH) Reactions (Induration and Redness) to NY-ESO-1 OLP4 at Screening and Week 16 | Presence of Induration at Week 16 | 1 Participants |
| Cohort 1 | Number of Patients With Delayed-type Hypersensitivity (DTH) Reactions (Induration and Redness) to NY-ESO-1 OLP4 at Screening and Week 16 | Presence of Redness at Screening | 0 Participants |
| Cohort 1 | Number of Patients With Delayed-type Hypersensitivity (DTH) Reactions (Induration and Redness) to NY-ESO-1 OLP4 at Screening and Week 16 | Presence of Redness at Week 16 | 0 Participants |
| Cohort 2 | Number of Patients With Delayed-type Hypersensitivity (DTH) Reactions (Induration and Redness) to NY-ESO-1 OLP4 at Screening and Week 16 | Presence of Redness at Week 16 | 6 Participants |
| Cohort 2 | Number of Patients With Delayed-type Hypersensitivity (DTH) Reactions (Induration and Redness) to NY-ESO-1 OLP4 at Screening and Week 16 | Presence of Induration at Screening | 0 Participants |
| Cohort 2 | Number of Patients With Delayed-type Hypersensitivity (DTH) Reactions (Induration and Redness) to NY-ESO-1 OLP4 at Screening and Week 16 | Presence of Redness at Screening | 2 Participants |
| Cohort 2 | Number of Patients With Delayed-type Hypersensitivity (DTH) Reactions (Induration and Redness) to NY-ESO-1 OLP4 at Screening and Week 16 | Presence of Induration at Week 16 | 4 Participants |
| Cohort 3 | Number of Patients With Delayed-type Hypersensitivity (DTH) Reactions (Induration and Redness) to NY-ESO-1 OLP4 at Screening and Week 16 | Presence of Redness at Week 16 | 4 Participants |
| Cohort 3 | Number of Patients With Delayed-type Hypersensitivity (DTH) Reactions (Induration and Redness) to NY-ESO-1 OLP4 at Screening and Week 16 | Presence of Induration at Week 16 | 2 Participants |
| Cohort 3 | Number of Patients With Delayed-type Hypersensitivity (DTH) Reactions (Induration and Redness) to NY-ESO-1 OLP4 at Screening and Week 16 | Presence of Redness at Screening | 2 Participants |
| Cohort 3 | Number of Patients With Delayed-type Hypersensitivity (DTH) Reactions (Induration and Redness) to NY-ESO-1 OLP4 at Screening and Week 16 | Presence of Induration at Screening | 0 Participants |
Secondary
Number of Patients With Detectable CD8+ and CD4+ T-cell Responses Up to 16 Weeks Post-Baseline
Blood samples were drawn to measure immunologic response at Screening and Weeks 4, 7, 10, 13, and 16. NY-ESO-1-specific CD8+ and CD4+ T-cell reactivity was measured by tetramer analysis (in human leukocyte antigen \[HLA\] 0201\* patients). Interferon gamma (IFN-γ) release by T cells was measured by the enzyme-linked immunospot (ELISPOT) assay. A subject was considered to have experienced a T-cell response if IFN-γ spots were detectable (\>50 spots) by ELISPOT of 50,000 CD8+ and CD4+ T cells following pre-sensitization with a pool of 20-mer OLP covering all of NY-ESO-1 and tested against Epstein-Barr virus-transformed B cells pulsed with 3 subpools of these peptides.
Time frame: Screening and Weeks 4, 7, 10, 13, and 16
Population: The Immune Response Analysis Set comprises all subjects who had available post-baseline results for a given immunologic measurement.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Number of Patients With Detectable CD8+ and CD4+ T-cell Responses Up to 16 Weeks Post-Baseline | Any CD8 T-cell Response Post-Baseline | 1 Participants |
| Cohort 1 | Number of Patients With Detectable CD8+ and CD4+ T-cell Responses Up to 16 Weeks Post-Baseline | Any CD4 T-cell Response Post-Baseline | 4 Participants |
| Cohort 2 | Number of Patients With Detectable CD8+ and CD4+ T-cell Responses Up to 16 Weeks Post-Baseline | Any CD8 T-cell Response Post-Baseline | 9 Participants |
| Cohort 2 | Number of Patients With Detectable CD8+ and CD4+ T-cell Responses Up to 16 Weeks Post-Baseline | Any CD4 T-cell Response Post-Baseline | 13 Participants |
| Cohort 3 | Number of Patients With Detectable CD8+ and CD4+ T-cell Responses Up to 16 Weeks Post-Baseline | Any CD8 T-cell Response Post-Baseline | 10 Participants |
| Cohort 3 | Number of Patients With Detectable CD8+ and CD4+ T-cell Responses Up to 16 Weeks Post-Baseline | Any CD4 T-cell Response Post-Baseline | 11 Participants |
Secondary
Number of Patients With Detectable Serum Immunoglobulin G (IgG) Antibody Titers Against NY-ESO-1 Up to 16 Weeks Post-Baseline
Blood samples were drawn to measure immunologic response at Screening and Weeks 4, 7, 10, 13, and 16. Specific antibodies against NY-ESO-1 were measured by enzyme-linked immunosorbent assay (ELISA).
Time frame: Screening and Weeks 4, 7, 10, 13, and 16
Population: The Immune Response Analysis Set comprises all subjects who had available post-baseline results for a given immunologic measurement.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Number of Patients With Detectable Serum Immunoglobulin G (IgG) Antibody Titers Against NY-ESO-1 Up to 16 Weeks Post-Baseline | Detectable IgG Antibody Titers: Week 16 | 1 Participants |
| Cohort 1 | Number of Patients With Detectable Serum Immunoglobulin G (IgG) Antibody Titers Against NY-ESO-1 Up to 16 Weeks Post-Baseline | Detectable IgG Antibody Titers: Week 7 | 1 Participants |
| Cohort 1 | Number of Patients With Detectable Serum Immunoglobulin G (IgG) Antibody Titers Against NY-ESO-1 Up to 16 Weeks Post-Baseline | Detectable IgG Antibody Titers: Week 13 | 1 Participants |
| Cohort 1 | Number of Patients With Detectable Serum Immunoglobulin G (IgG) Antibody Titers Against NY-ESO-1 Up to 16 Weeks Post-Baseline | Detectable IgG Antibody Titers: Pretreatment | 1 Participants |
| Cohort 1 | Number of Patients With Detectable Serum Immunoglobulin G (IgG) Antibody Titers Against NY-ESO-1 Up to 16 Weeks Post-Baseline | Detectable IgG Antibody Titers: Week 10 | 1 Participants |
| Cohort 1 | Number of Patients With Detectable Serum Immunoglobulin G (IgG) Antibody Titers Against NY-ESO-1 Up to 16 Weeks Post-Baseline | Detectable IgG Antibody Titers: Week 4 | 1 Participants |
| Cohort 2 | Number of Patients With Detectable Serum Immunoglobulin G (IgG) Antibody Titers Against NY-ESO-1 Up to 16 Weeks Post-Baseline | Detectable IgG Antibody Titers: Week 10 | 4 Participants |
| Cohort 2 | Number of Patients With Detectable Serum Immunoglobulin G (IgG) Antibody Titers Against NY-ESO-1 Up to 16 Weeks Post-Baseline | Detectable IgG Antibody Titers: Week 13 | 4 Participants |
| Cohort 2 | Number of Patients With Detectable Serum Immunoglobulin G (IgG) Antibody Titers Against NY-ESO-1 Up to 16 Weeks Post-Baseline | Detectable IgG Antibody Titers: Week 4 | 0 Participants |
| Cohort 2 | Number of Patients With Detectable Serum Immunoglobulin G (IgG) Antibody Titers Against NY-ESO-1 Up to 16 Weeks Post-Baseline | Detectable IgG Antibody Titers: Week 16 | 6 Participants |
| Cohort 2 | Number of Patients With Detectable Serum Immunoglobulin G (IgG) Antibody Titers Against NY-ESO-1 Up to 16 Weeks Post-Baseline | Detectable IgG Antibody Titers: Pretreatment | 0 Participants |
| Cohort 2 | Number of Patients With Detectable Serum Immunoglobulin G (IgG) Antibody Titers Against NY-ESO-1 Up to 16 Weeks Post-Baseline | Detectable IgG Antibody Titers: Week 7 | 0 Participants |
| Cohort 3 | Number of Patients With Detectable Serum Immunoglobulin G (IgG) Antibody Titers Against NY-ESO-1 Up to 16 Weeks Post-Baseline | Detectable IgG Antibody Titers: Week 7 | 7 Participants |
| Cohort 3 | Number of Patients With Detectable Serum Immunoglobulin G (IgG) Antibody Titers Against NY-ESO-1 Up to 16 Weeks Post-Baseline | Detectable IgG Antibody Titers: Pretreatment | 1 Participants |
| Cohort 3 | Number of Patients With Detectable Serum Immunoglobulin G (IgG) Antibody Titers Against NY-ESO-1 Up to 16 Weeks Post-Baseline | Detectable IgG Antibody Titers: Week 4 | 1 Participants |
| Cohort 3 | Number of Patients With Detectable Serum Immunoglobulin G (IgG) Antibody Titers Against NY-ESO-1 Up to 16 Weeks Post-Baseline | Detectable IgG Antibody Titers: Week 16 | 8 Participants |
| Cohort 3 | Number of Patients With Detectable Serum Immunoglobulin G (IgG) Antibody Titers Against NY-ESO-1 Up to 16 Weeks Post-Baseline | Detectable IgG Antibody Titers: Week 10 | 8 Participants |
| Cohort 3 | Number of Patients With Detectable Serum Immunoglobulin G (IgG) Antibody Titers Against NY-ESO-1 Up to 16 Weeks Post-Baseline | Detectable IgG Antibody Titers: Week 13 | 8 Participants |
Secondary
Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline
Radiographic imaging (computed tomography of the abdomen and pelvis) was obtained at Screening and every 2 months during the study, and at unscheduled time points if any clinical symptoms/examination findings warranted further evaluation or if serum CA-125 rose to \> 70 U/mL (confirmed by repeat value). Subjects may have had more than 1 location of disease.
Time frame: Screening and every 2 months up to Week 16
Population: The Tumor Response Analysis Set comprises all subjects who had a given post-baseline efficacy assessment performed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline | Week 7: Evidence of Disease | 1 Participants |
| Cohort 1 | Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline | Week 7: Disease Location - Regional Lymph Node | 1 Participants |
| Cohort 1 | Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline | Week 7: Disease Location - Liver | 0 Participants |
| Cohort 1 | Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline | Week 7: Disease Location - Other | 0 Participants |
| Cohort 1 | Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline | Week 16: Evidence of Disease | 0 Participants |
| Cohort 1 | Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline | Week 16: Disease Location - Local Recurrence | 0 Participants |
| Cohort 1 | Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline | Week 16: Disease Location - Liver | 0 Participants |
| Cohort 1 | Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline | Screening: Evidence of Disease | 0 Participants |
| Cohort 2 | Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline | Week 7: Disease Location - Liver | 0 Participants |
| Cohort 2 | Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline | Week 16: Disease Location - Liver | 1 Participants |
| Cohort 2 | Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline | Week 7: Disease Location - Other | 0 Participants |
| Cohort 2 | Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline | Week 16: Evidence of Disease | 4 Participants |
| Cohort 2 | Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline | Week 16: Disease Location - Local Recurrence | 4 Participants |
| Cohort 2 | Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline | Week 7: Evidence of Disease | 0 Participants |
| Cohort 2 | Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline | Week 7: Disease Location - Regional Lymph Node | 0 Participants |
| Cohort 2 | Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline | Screening: Evidence of Disease | 0 Participants |
| Cohort 3 | Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline | Week 7: Disease Location - Liver | 1 Participants |
| Cohort 3 | Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline | Week 7: Disease Location - Regional Lymph Node | 0 Participants |
| Cohort 3 | Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline | Week 7: Evidence of Disease | 1 Participants |
| Cohort 3 | Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline | Week 7: Disease Location - Other | 1 Participants |
| Cohort 3 | Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline | Week 16: Disease Location - Liver | 1 Participants |
| Cohort 3 | Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline | Week 16: Disease Location - Local Recurrence | 0 Participants |
| Cohort 3 | Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline | Week 16: Evidence of Disease | 1 Participants |
| Cohort 3 | Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline | Screening: Evidence of Disease | 0 Participants |