Phase 1 Study of NY-ESO-1 Overlapping Peptides in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

• Sponsor: Ludwig Institute for Cancer Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT00616941
• Collaborator: Memorial Sloan Kettering Cancer Center (Other)
• Enrollment: 28
• Location: 1
• Arms: 3
• Actual Duration (Months): 39
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer	Biological: NY-ESO-1 OLP4; Biological: NY-ESO-1 OLP4 + Montanide; Biological: NY-ESO-1 OLP4 + Montanide + Poly-ICLC	Phase 1

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1 Study of NY-ESO-1 Overlapping Peptides With or Without Immunoadjuvants Montanide and Poly-ICLC Vaccination of Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer Patients in Second or Third Remission
• Actual Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Biological: NY-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.
Experimental: 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 vegetable grade (VG) once every 3 weeks for a total of 5 vaccinations.	Biological: NY-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.
Experimental: 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.	Biological: NY-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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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).

2. 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.

3. 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.

4. 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).

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

1. Age ≥ 18 years.

2. ≥ 4 weeks since completion of prior cytotoxic chemotherapy.

3. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021

Sponsors and Collaborators

• Ludwig Institute for Cancer Research
• Memorial Sloan Kettering Cancer Center

Investigators

• Principal Investigator: Paul Sabbatini, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ludwig Institute for Cancer Research
• ClinicalTrials.gov Identifier: NCT00616941
• Other Study ID Numbers: LUD2006-001; MSKCC IRB# 07-152
• First Posted: Feb 15, 2008
• Last Update Posted: Jul 27, 2018
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ludwig Institute for Cancer Research: NY-ESO-1 OLP4; Ovarian Cancer; Cancer Vaccine
• Additional relevant MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Monatide (IMS 3015); Poly ICLC

Study Results

Participant Flow

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3
Arm/Group Description	Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 overlapping peptides [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 5% dextrose in water (D5W) and administered subcutaneously as a single injection.	Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 vegetable grade (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.	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 polyinosinic-polycytidylic acid - poly-L-lysine carboxymethylcellulose (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.
Period Title: Overall Study
STARTED	4	13	11
COMPLETED	3	8	5
NOT COMPLETED	1	5	6

Baseline Characteristics

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Total
Arm/Group Description	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.	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.	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.	Total of all reporting groups
Overall Participants	4	13	11	28
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.8 (10.7)	58.6 (7.7)	57.1 (9.5)	57.8 (8.5)
Sex: Female, Male (Count of Participants)
Female	4 100%	13 100%	11 100%	28 100%
Male	0 0%	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	4 100%	13 100%	11 100%	28 100%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	1 9.1%	1 3.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	4 100%	13 100%	10 90.9%	27 96.4%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	4 100%	13 100%	11 100%	28 100%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	23.6 (4.8)	29.1 (8.1)	26.5 (6.6)	27.3 (7.2)

Outcome Measures

1. Primary Outcome

Title	Overview of Treatment-emergent Adverse Events (TEAEs)
Description	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

Outcome Measure Data

Analysis Population Description

The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3
Arm/Group Description	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.	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.	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.
Measure Participants	4	13	11
Any TEAE	3 75%	13 100%	11 100%
Treatment-related TEAE	2 50%	12 92.3%	11 100%
TEAE Leading to Discontinuation	0 0%	3 23.1%	1 9.1%
Dose-limiting toxicity	0 0%	1 7.7%	0 0%
Serious TEAE	0 0%	1 7.7%	0 0%
Death	0 0%	0 0%	0 0%

2. Secondary Outcome

Title	Number of Patients With Detectable Serum Immunoglobulin G (IgG) Antibody Titers Against NY-ESO-1 Up to 16 Weeks Post-Baseline
Description	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

Outcome Measure Data

Analysis Population Description

The Immune Response Analysis Set comprises all subjects who had available post-baseline results for a given immunologic measurement.

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3
Arm/Group Description	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.	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.	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.
Measure Participants	4	13	11
Detectable IgG Antibody Titers: Pretreatment	1 25%	0 0%	1 9.1%
Detectable IgG Antibody Titers: Week 4	1 25%	0 0%	1 9.1%
Detectable IgG Antibody Titers: Week 7	1 25%	0 0%	7 63.6%
Detectable IgG Antibody Titers: Week 10	1 25%	4 30.8%	8 72.7%
Detectable IgG Antibody Titers: Week 13	1 25%	4 30.8%	8 72.7%
Detectable IgG Antibody Titers: Week 16	1 25%	6 46.2%	8 72.7%

3. Secondary Outcome

Title	Number of Patients With Detectable CD8+ and CD4+ T-cell Responses Up to 16 Weeks Post-Baseline
Description	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

Outcome Measure Data

Analysis Population Description

The Immune Response Analysis Set comprises all subjects who had available post-baseline results for a given immunologic measurement.

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3
Arm/Group Description	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.	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.	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.
Measure Participants	4	13	11
Any CD8 T-cell Response Post-Baseline	1 25%	9 69.2%	10 90.9%
Any CD4 T-cell Response Post-Baseline	4 100%	13 100%	11 100%

4. Secondary Outcome

Title	Number of Patients With Delayed-type Hypersensitivity (DTH) Reactions (Induration and Redness) to NY-ESO-1 OLP4 at Screening and Week 16
Description	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

Outcome Measure Data

Analysis Population Description

The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3
Arm/Group Description	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.	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.	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.
Measure Participants	4	13	11
Presence of Induration at Screening	0 0%	0 0%	0 0%
Presence of Induration at Week 16	1 25%	4 30.8%	2 18.2%
Presence of Redness at Screening	0 0%	2 15.4%	2 18.2%
Presence of Redness at Week 16	0 0%	6 46.2%	4 36.4%

5. Secondary Outcome

Title	Cancer Antigen (CA)-125 Levels Up to 16 Weeks Post-Baseline
Description	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

Outcome Measure Data

Analysis Population Description

The Tumor Response Analysis Set comprises all subjects who had a given post-baseline efficacy measurement performed.

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3
Arm/Group Description	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.	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.	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.
Measure Participants	4	13	11
Screening	14.0 (12.7)	8.5 (5.3)	10.9 (4.4)
Week 7	29.5 (44.3)	13.8 (12.5)	21.3 (25.8)
Week 16	8.0 (1.0)	12.9 (9.7)	35.1 (66.0)

6. Secondary Outcome

Title	Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline
Description	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

Outcome Measure Data

Analysis Population Description

The Tumor Response Analysis Set comprises all subjects who had a given post-baseline efficacy assessment performed.

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3
Arm/Group Description	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.	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.	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.
Measure Participants	4	13	11
Screening: Evidence of Disease	0 0%	0 0%	0 0%
Week 7: Evidence of Disease	1 25%	0 0%	1 9.1%
Week 7: Disease Location - Regional Lymph Node	1 25%	0 0%	0 0%
Week 7: Disease Location - Liver	0 0%	0 0%	1 9.1%
Week 7: Disease Location - Other	0 0%	0 0%	1 9.1%
Week 16: Evidence of Disease	0 0%	4 30.8%	1 9.1%
Week 16: Disease Location - Local Recurrence	0 0%	4 30.8%	0 0%
Week 16: Disease Location - Liver	0 0%	1 7.7%	1 9.1%

Adverse Events

Time Frame	All AEs occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 16 weeks for each subject.
Adverse Event Reporting Description	AE documentation included onset/resolution dates, severity using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 3.0), frequency, seriousness, related interventions, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
Arm/Group Title	Cohort 1		Cohort 2		Cohort 3
Arm/Group Description	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.		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.		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.
All Cause Mortality
	Cohort 1		Cohort 2		Cohort 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/13 (0%)		0/11 (0%)
Serious Adverse Events
	Cohort 1		Cohort 2		Cohort 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		1/13 (7.7%)		0/11 (0%)
Infections and infestations
Pneumonia	0/4 (0%)		1/13 (7.7%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Cohort 1		Cohort 2		Cohort 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/4 (75%)		13/13 (100%)		11/11 (100%)
Blood and lymphatic system disorders
Lymphadenopathy	0/4 (0%)		1/13 (7.7%)		0/11 (0%)
Neutropenia	0/4 (0%)		1/13 (7.7%)		0/11 (0%)
Ear and labyrinth disorders
Tinnitus	0/4 (0%)		0/13 (0%)		1/11 (9.1%)
Eye disorders
Visual acuity reduced	0/4 (0%)		1/13 (7.7%)		0/11 (0%)
Gastrointestinal disorders
Nausea	0/4 (0%)		4/13 (30.8%)		1/11 (9.1%)
Abdominal pain upper	0/4 (0%)		0/13 (0%)		2/11 (18.2%)
Diarrhoea	0/4 (0%)		1/13 (7.7%)		1/11 (9.1%)
Abdominal discomfort	0/4 (0%)		1/13 (7.7%)		0/11 (0%)
Abdominal pain	0/4 (0%)		1/13 (7.7%)		0/11 (0%)
Abdominal pain lower	0/4 (0%)		0/13 (0%)		1/11 (9.1%)
Constipation	0/4 (0%)		0/13 (0%)		1/11 (9.1%)
Gastrooesophageal reflux disease	0/4 (0%)		1/13 (7.7%)		0/11 (0%)
Vomiting	0/4 (0%)		0/13 (0%)		1/11 (9.1%)
General disorders
Injection site reaction	1/4 (25%)		7/13 (53.8%)		10/11 (90.9%)
Fatigue	2/4 (50%)		6/13 (46.2%)		3/11 (27.3%)
Injection site pain	0/4 (0%)		1/13 (7.7%)		3/11 (27.3%)
Pyrexia	0/4 (0%)		1/13 (7.7%)		2/11 (18.2%)
Influenza like illness	0/4 (0%)		2/13 (15.4%)		0/11 (0%)
Hernia	0/4 (0%)		1/13 (7.7%)		0/11 (0%)
Injection site erythema	0/4 (0%)		1/13 (7.7%)		0/11 (0%)
Injection site pruritus	0/4 (0%)		1/13 (7.7%)		0/11 (0%)
Injection site rash	0/4 (0%)		1/13 (7.7%)		0/11 (0%)
Oedema	0/4 (0%)		1/13 (7.7%)		0/11 (0%)
Oedema peripheral	0/4 (0%)		1/13 (7.7%)		0/11 (0%)
Infections and infestations
Upper respiratory tract infection	1/4 (25%)		3/13 (23.1%)		1/11 (9.1%)
Urinary tract infection	0/4 (0%)		1/13 (7.7%)		3/11 (27.3%)
Bronchitis	0/4 (0%)		1/13 (7.7%)		0/11 (0%)
Laryngitis	0/4 (0%)		0/13 (0%)		1/11 (9.1%)
Oral herpes	0/4 (0%)		1/13 (7.7%)		0/11 (0%)
Injury, poisoning and procedural complications
Contusion	0/4 (0%)		2/13 (15.4%)		0/11 (0%)
Joint sprain	0/4 (0%)		0/13 (0%)		1/11 (9.1%)
Muscle strain	0/4 (0%)		1/13 (7.7%)		0/11 (0%)
Investigations
Blood potassium decreased	0/4 (0%)		1/13 (7.7%)		0/11 (0%)
Neutrophil count abnormal	0/4 (0%)		1/13 (7.7%)		0/11 (0%)
Musculoskeletal and connective tissue disorders
Myalgia	0/4 (0%)		2/13 (15.4%)		2/11 (18.2%)
Arthralgia	0/4 (0%)		1/13 (7.7%)		2/11 (18.2%)
Back pain	0/4 (0%)		0/13 (0%)		1/11 (9.1%)
Muscle spasms	0/4 (0%)		0/13 (0%)		1/11 (9.1%)
Musculoskeletal pain	0/4 (0%)		0/13 (0%)		1/11 (9.1%)
Musculoskeletal stiffness	0/4 (0%)		0/13 (0%)		1/11 (9.1%)
Pain in extremity	0/4 (0%)		0/13 (0%)		1/11 (9.1%)
Nervous system disorders
Headache	1/4 (25%)		1/13 (7.7%)		0/11 (0%)
Neuropathy peripheral	0/4 (0%)		1/13 (7.7%)		0/11 (0%)
Psychiatric disorders
Insomnia	1/4 (25%)		0/13 (0%)		1/11 (9.1%)
Renal and urinary disorders
Urinary incontinence	0/4 (0%)		0/13 (0%)		1/11 (9.1%)
Reproductive system and breast disorders
Pelvic pain	0/4 (0%)		0/13 (0%)		1/11 (9.1%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional	0/4 (0%)		2/13 (15.4%)		0/11 (0%)
Cough	0/4 (0%)		0/13 (0%)		1/11 (9.1%)
Dyspnoea	0/4 (0%)		1/13 (7.7%)		0/11 (0%)
Nasal congestion	0/4 (0%)		1/13 (7.7%)		0/11 (0%)
Productive cough	0/4 (0%)		1/13 (7.7%)		0/11 (0%)
Pulmonary congestion	0/4 (0%)		1/13 (7.7%)		0/11 (0%)
Sinus congestion	0/4 (0%)		0/13 (0%)		1/11 (9.1%)
Skin and subcutaneous tissue disorders
Erythema	0/4 (0%)		1/13 (7.7%)		1/11 (9.1%)
Dermatitis contact	0/4 (0%)		1/13 (7.7%)		0/11 (0%)
Panniculitis	0/4 (0%)		0/13 (0%)		1/11 (9.1%)
Rash	0/4 (0%)		1/13 (7.7%)		0/11 (0%)
Skin nodule	0/4 (0%)		0/13 (0%)		1/11 (9.1%)
Urticaria	1/4 (25%)		0/13 (0%)		0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.