Trial Outcomes & Findings for Phase 1 Study of NY-ESO-1 Overlapping Peptides in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (NCT NCT00616941)

Last Updated: 2022-10-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

28 participants

Primary outcome timeframe

Continuously for up to 16 weeks

Results posted on

2022-10-12

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1 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.	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. 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.	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 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.
Overall Study STARTED	4	13	11
Overall Study COMPLETED	3	8	5
Overall Study NOT COMPLETED	1	5	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 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.	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. 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.	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 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.
Overall Study Progressive Disease	1	2	1
Overall Study Adverse Event	0	1	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

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=4 Participants 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.	Cohort 2 n=13 Participants 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.	Cohort 3 n=11 Participants 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 n=28 Participants Total of all reporting groups
Age, Continuous	56.8 years STANDARD_DEVIATION 10.7 • n=5 Participants	58.6 years STANDARD_DEVIATION 7.7 • n=7 Participants	57.1 years STANDARD_DEVIATION 9.5 • n=5 Participants	57.8 years STANDARD_DEVIATION 8.5 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	13 Participants n=7 Participants	11 Participants n=5 Participants	28 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	13 Participants n=7 Participants	11 Participants n=5 Participants	28 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	13 Participants n=7 Participants	10 Participants n=5 Participants	27 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	4 Participants n=5 Participants	13 Participants n=7 Participants	11 Participants n=5 Participants	28 Participants n=4 Participants
Body Mass Index	23.6 kg/m^2 STANDARD_DEVIATION 4.8 • n=5 Participants	29.1 kg/m^2 STANDARD_DEVIATION 8.1 • n=7 Participants	26.5 kg/m^2 STANDARD_DEVIATION 6.6 • n=5 Participants	27.3 kg/m^2 STANDARD_DEVIATION 7.2 • n=4 Participants

PRIMARY outcome

Timeframe: Continuously for up to 16 weeks

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

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.

Outcome measures

Outcome measures
Measure	Cohort 1 n=4 Participants 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.	Cohort 2 n=13 Participants 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.	Cohort 3 n=11 Participants 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.
Overview of Treatment-emergent Adverse Events (TEAEs) Serious TEAE	0 Participants	1 Participants	0 Participants
Overview of Treatment-emergent Adverse Events (TEAEs) Death	0 Participants	0 Participants	0 Participants
Overview of Treatment-emergent Adverse Events (TEAEs) Any TEAE	3 Participants	13 Participants	11 Participants
Overview of Treatment-emergent Adverse Events (TEAEs) Treatment-related TEAE	2 Participants	12 Participants	11 Participants
Overview of Treatment-emergent Adverse Events (TEAEs) TEAE Leading to Discontinuation	0 Participants	3 Participants	1 Participants
Overview of Treatment-emergent Adverse Events (TEAEs) Dose-limiting toxicity	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Cohort 1 n=4 Participants 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.	Cohort 2 n=13 Participants 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.	Cohort 3 n=11 Participants 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.
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	0 Participants	1 Participants
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	0 Participants	7 Participants
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	4 Participants	8 Participants
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	6 Participants	8 Participants
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	4 Participants	8 Participants
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	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Cohort 1 n=4 Participants 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.	Cohort 2 n=13 Participants 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.	Cohort 3 n=11 Participants 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.
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	9 Participants	10 Participants
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	13 Participants	11 Participants

SECONDARY outcome

Timeframe: Screening and Week 16

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

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.

Outcome measures

Outcome measures
Measure	Cohort 1 n=4 Participants 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.	Cohort 2 n=13 Participants 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.	Cohort 3 n=11 Participants 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.
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	0 Participants	0 Participants
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	4 Participants	2 Participants
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	2 Participants	2 Participants
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	6 Participants	4 Participants

SECONDARY outcome

Timeframe: Screening, Week 7, and Week 16

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

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).

Outcome measures

Outcome measures
Measure	Cohort 1 n=4 Participants 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.	Cohort 2 n=13 Participants 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.	Cohort 3 n=11 Participants 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.
Cancer Antigen (CA)-125 Levels Up to 16 Weeks Post-Baseline Week 16	8.0 U/mL Standard Deviation 1.0	12.9 U/mL Standard Deviation 9.7	35.1 U/mL Standard Deviation 66.0
Cancer Antigen (CA)-125 Levels Up to 16 Weeks Post-Baseline Screening	14.0 U/mL Standard Deviation 12.7	8.5 U/mL Standard Deviation 5.3	10.9 U/mL Standard Deviation 4.4
Cancer Antigen (CA)-125 Levels Up to 16 Weeks Post-Baseline Week 7	29.5 U/mL Standard Deviation 44.3	13.8 U/mL Standard Deviation 12.5	21.3 U/mL Standard Deviation 25.8

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Cohort 1 n=4 Participants 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.	Cohort 2 n=13 Participants 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.	Cohort 3 n=11 Participants 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.
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	4 Participants	0 Participants
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	0 Participants	0 Participants
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	0 Participants	1 Participants
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	0 Participants	1 Participants
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	4 Participants	1 Participants
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	0 Participants	1 Participants
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	0 Participants	0 Participants
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	1 Participants	1 Participants

Adverse Events

Cohort 1

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 2

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Cohort 3

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1 n=4 participants at risk 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.	Cohort 2 n=13 participants at risk 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.	Cohort 3 n=11 participants at risk 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.
Infections and infestations Pneumonia	0.00% 0/4 • 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. 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.	7.7% 1/13 • 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. 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.	0.00% 0/11 • 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. 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.

Other adverse events

Additional Information

Jonathan Skipper PhD

Ludwig Institute for Cancer Research

Phone: 12124501539

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60