Trial Outcomes & Findings for Vaccine Therapy in Patients With Stage II, III, or IV Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer (NCT NCT00112957)

Last Updated: 2023-10-04

Results Overview

Time to failure (TTF) was evaluated as the crude proportion of patients in remission at 1 year, calculated as: 100 x (number of patients in remission at 1 year)/(number of patients with known status at 1 year). The Kaplan-Meier cumulative estimate of the proportion of patients in remission at 1 year was also calculated.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

12 months

Results posted on

2023-10-04

Participant Flow

Participant milestones

Participant milestones
Measure	rV- and rF-NY-ESO-1 Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10\^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10\^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
Overall Study STARTED	23
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Reasons for withdrawal
Measure	rV- and rF-NY-ESO-1 Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10\^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10\^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
Overall Study Progressive disease	18
Overall Study Physician Decision	1

Baseline Characteristics

Vaccine Therapy in Patients With Stage II, III, or IV Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	rV- and rF-NY-ESO-1 n=23 Participants Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10\^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10\^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
Age, Continuous	55 years n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants
Karnofsky Performance Status 70	1 Participants n=5 Participants
Karnofsky Performance Status 80	3 Participants n=5 Participants
Karnofsky Performance Status 90	3 Participants n=5 Participants
Karnofsky Performance Status 100	16 Participants n=5 Participants
Body mass index	29.5 kg/m^2 STANDARD_DEVIATION 4.7 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: The Full Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1 and met the entry criterion of having epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. One patient with breast cancer was treated in the protocol under compassionate use and is excluded from the Full Analysis Set.

Outcome measures

Outcome measures
Measure	rV- and rF-NY-ESO-1 n=22 Participants Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10\^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10\^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
Percentage of Patients in Remission at 1 Year Crude rate	38.1 percentage of participants Interval 18.1 to 61.6
Percentage of Patients in Remission at 1 Year Kaplan-Meier cumulative rate	38.8 percentage of participants Interval 18.8 to 58.5

SECONDARY outcome

Timeframe: Up to 20 months

Population: The Full Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1 and met the entry criterion of having epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. TTF was calculated for the subset of patients who had disease progression at any time.

TTF was calculated as the number of days from the first dose until the patient discontinued due to progressive disease. Patients who completed the study or discontinued for other reasons were considered censored at the day of their last study visit, including the follow-up visits after Day 197. Progression was defined using the Response Evaluation Criteria In Solid Tumors (RECIST \[version 1.0\]) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Outcome measures

Outcome measures
Measure	rV- and rF-NY-ESO-1 n=17 Participants Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10\^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10\^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
Mean Time to Failure Among Patients Who Progressed On Study	253.1 days Standard Deviation 160.4

SECONDARY outcome

Timeframe: Up to 20 months

Tumor responses were evaluated using computed tomography and were categorized according to RECIST (version 1.0) at Screening, on Days 85 and 197 and every 2 months thereafter for at least 12 months. Per RECIST, target lesions are categorized as follows: Complete Response (CR): Disappearance of all target lesions (no evaluable 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.

Outcome measures

Outcome measures
Measure	rV- and rF-NY-ESO-1 n=22 Participants Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10\^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10\^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
Number of Patients With Best Overall Tumor Response Response at Day 85 · Stable Disease	3 Participants
Number of Patients With Best Overall Tumor Response Response at Day 85 · Progressive Disease	0 Participants
Number of Patients With Best Overall Tumor Response Response at Day 85 · No Evaluable Disease	15 Participants
Number of Patients With Best Overall Tumor Response Response at Day 85 · Missing/Not Done	4 Participants
Number of Patients With Best Overall Tumor Response Response at Day 197 · Stable Disease	3 Participants
Number of Patients With Best Overall Tumor Response Response at Day 197 · Progressive Disease	1 Participants
Number of Patients With Best Overall Tumor Response Response at Day 197 · No Evaluable Disease	11 Participants
Number of Patients With Best Overall Tumor Response Response at Day 197 · Missing/Not Done	7 Participants
Number of Patients With Best Overall Tumor Response Response at 12-Month Follow-up · Stable Disease	0 Participants
Number of Patients With Best Overall Tumor Response Response at 12-Month Follow-up · Progressive Disease	0 Participants
Number of Patients With Best Overall Tumor Response Response at 12-Month Follow-up · No Evaluable Disease	4 Participants
Number of Patients With Best Overall Tumor Response Response at 12-Month Follow-up · Missing/Not Done	18 Participants
Number of Patients With Best Overall Tumor Response Response at End of Study · Stable Disease	3 Participants
Number of Patients With Best Overall Tumor Response Response at End of Study · Progressive Disease	4 Participants
Number of Patients With Best Overall Tumor Response Response at End of Study · No Evaluable Disease	0 Participants
Number of Patients With Best Overall Tumor Response Response at End of Study · Missing/Not Done	15 Participants

SECONDARY outcome

Timeframe: Up to 20 months

Blood samples were collected to measure serum levels of tumor marker cancer antigen (CA)-125 at Screening and on Days 1, 29, 57, 85, 113, 141, 169, and 197 and every 2 months for at least 12 months following Day 197.

Outcome measures

Outcome measures
Measure	rV- and rF-NY-ESO-1 n=22 Participants Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10\^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10\^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
Mean Absolute Cancer Antigen-125 Values Over Time on Study CA-125 at Baseline	17.9 U/mL Standard Deviation 15.4
Mean Absolute Cancer Antigen-125 Values Over Time on Study CA-125 at Day 29	27.5 U/mL Standard Deviation 40.7
Mean Absolute Cancer Antigen-125 Values Over Time on Study CA-125 at Day 57	74.8 U/mL Standard Deviation 203.7
Mean Absolute Cancer Antigen-125 Values Over Time on Study CA-125 at Day 85	12.8 U/mL Standard Deviation 9.6
Mean Absolute Cancer Antigen-125 Values Over Time on Study CA-125 at Day 113	20.4 U/mL Standard Deviation 33.6
Mean Absolute Cancer Antigen-125 Values Over Time on Study CA-125 at Day 141	11.8 U/mL Standard Deviation 7.2
Mean Absolute Cancer Antigen-125 Values Over Time on Study CA-125 at Day 169	14.1 U/mL Standard Deviation 9.3
Mean Absolute Cancer Antigen-125 Values Over Time on Study CA-125 at Day 197	16.0 U/mL Standard Deviation 13.4
Mean Absolute Cancer Antigen-125 Values Over Time on Study Follow-up at Month 2	80.7 U/mL Standard Deviation 205.9
Mean Absolute Cancer Antigen-125 Values Over Time on Study Follow-up at Month 4	16.0 U/mL Standard Deviation 14.6
Mean Absolute Cancer Antigen-125 Values Over Time on Study Follow-up at Month 6	80.4 U/mL Standard Deviation 187.2
Mean Absolute Cancer Antigen-125 Values Over Time on Study Follow-up at Month 8	10.6 U/mL Standard Deviation 3.5
Mean Absolute Cancer Antigen-125 Values Over Time on Study Follow-up at Month 10	59.5 U/mL Standard Deviation 120.5
Mean Absolute Cancer Antigen-125 Values Over Time on Study Follow-up at Month 12	16.8 U/mL Standard Deviation 12.6

SECONDARY outcome

Timeframe: Up to 20 months

Specific antibody response to the NY-ESO-1 and LAGE-1 antigen was measured by enzyme-linked immunosorbent assay (ELISA) at Screening, Days 29, 57, 85, 113, 141, 169, 197, Month 6, and Month 12.

Outcome measures

Outcome measures
Measure	rV- and rF-NY-ESO-1 n=22 Participants Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10\^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10\^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
Number of Patients With NY-ESO-1 and LAGE-1-specific Immunity Screening: NY-ESO-1 Positive	3 Participants
Number of Patients With NY-ESO-1 and LAGE-1-specific Immunity Screening: LAGE-1 Positive	2 Participants
Number of Patients With NY-ESO-1 and LAGE-1-specific Immunity Day 29: NY-ESO-1 Positive	7 Participants
Number of Patients With NY-ESO-1 and LAGE-1-specific Immunity Day 29: LAGE-1 Positive	5 Participants
Number of Patients With NY-ESO-1 and LAGE-1-specific Immunity Day 57: NY-ESO-1 Positive	6 Participants
Number of Patients With NY-ESO-1 and LAGE-1-specific Immunity Day 57: LAGE-1 Positive	4 Participants
Number of Patients With NY-ESO-1 and LAGE-1-specific Immunity Day 85: NY-ESO-1 Positive	5 Participants
Number of Patients With NY-ESO-1 and LAGE-1-specific Immunity Day 85: LAGE-1 Positive	4 Participants
Number of Patients With NY-ESO-1 and LAGE-1-specific Immunity Day 113: NY-ESO-1 Positive	6 Participants
Number of Patients With NY-ESO-1 and LAGE-1-specific Immunity Day 113: LAGE-1 Positive	3 Participants
Number of Patients With NY-ESO-1 and LAGE-1-specific Immunity Day 141: NY-ESO-1 Positive	5 Participants
Number of Patients With NY-ESO-1 and LAGE-1-specific Immunity Day 141: LAGE-1 Positive	3 Participants
Number of Patients With NY-ESO-1 and LAGE-1-specific Immunity Day 169: NY-ESO-1 Positive	5 Participants
Number of Patients With NY-ESO-1 and LAGE-1-specific Immunity Day 169: LAGE-1 Positive	3 Participants
Number of Patients With NY-ESO-1 and LAGE-1-specific Immunity Day 197: NY-ESO-1 Positive	5 Participants
Number of Patients With NY-ESO-1 and LAGE-1-specific Immunity Day 197: LAGE-1 Positive	3 Participants
Number of Patients With NY-ESO-1 and LAGE-1-specific Immunity Month 6: NY-ESO-1 Positive	4 Participants
Number of Patients With NY-ESO-1 and LAGE-1-specific Immunity Month 6: LAGE-1 Positive	0 Participants
Number of Patients With NY-ESO-1 and LAGE-1-specific Immunity Month 12: NY-ESO-1 Positive	1 Participants
Number of Patients With NY-ESO-1 and LAGE-1-specific Immunity Month 12: LAGE-1 Positive	1 Participants

SECONDARY outcome

Timeframe: Up to 20 months

Intracellular cytokine staining assays were performed at Screening, Days 85 and 197, Month 6, and Month 12 to evaluate the release of interferon-gamma by CD4 and CD8 T cells following study injections.

Outcome measures

Outcome measures
Measure	rV- and rF-NY-ESO-1 n=22 Participants Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10\^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10\^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
Number of Patients With Release of Interferon-Gamma by T Cells in Response to Cancer Antigens Screening: CD4 · Positive	10 Participants
Number of Patients With Release of Interferon-Gamma by T Cells in Response to Cancer Antigens Screening: CD4 · Negative	12 Participants
Number of Patients With Release of Interferon-Gamma by T Cells in Response to Cancer Antigens Screening: CD8 · Positive	2 Participants
Number of Patients With Release of Interferon-Gamma by T Cells in Response to Cancer Antigens Screening: CD8 · Negative	20 Participants
Number of Patients With Release of Interferon-Gamma by T Cells in Response to Cancer Antigens Day 85: CD4 · Positive	13 Participants
Number of Patients With Release of Interferon-Gamma by T Cells in Response to Cancer Antigens Day 85: CD4 · Negative	5 Participants
Number of Patients With Release of Interferon-Gamma by T Cells in Response to Cancer Antigens Day 85: CD8 · Positive	6 Participants
Number of Patients With Release of Interferon-Gamma by T Cells in Response to Cancer Antigens Day 85: CD8 · Negative	12 Participants
Number of Patients With Release of Interferon-Gamma by T Cells in Response to Cancer Antigens Day 197: CD4 · Positive	12 Participants
Number of Patients With Release of Interferon-Gamma by T Cells in Response to Cancer Antigens Day 197: CD4 · Negative	3 Participants
Number of Patients With Release of Interferon-Gamma by T Cells in Response to Cancer Antigens Day 197: CD8 · Positive	5 Participants
Number of Patients With Release of Interferon-Gamma by T Cells in Response to Cancer Antigens Day 197: CD8 · Negative	9 Participants
Number of Patients With Release of Interferon-Gamma by T Cells in Response to Cancer Antigens Month 6: CD4 · Positive	6 Participants
Number of Patients With Release of Interferon-Gamma by T Cells in Response to Cancer Antigens Month 6: CD4 · Negative	2 Participants
Number of Patients With Release of Interferon-Gamma by T Cells in Response to Cancer Antigens Month 6: CD8 · Positive	3 Participants
Number of Patients With Release of Interferon-Gamma by T Cells in Response to Cancer Antigens Month 6: CD8 · Negative	5 Participants
Number of Patients With Release of Interferon-Gamma by T Cells in Response to Cancer Antigens Month 12: CD4 · Positive	3 Participants
Number of Patients With Release of Interferon-Gamma by T Cells in Response to Cancer Antigens Month 12: CD4 · Negative	1 Participants
Number of Patients With Release of Interferon-Gamma by T Cells in Response to Cancer Antigens Month 12: CD8 · Positive	1 Participants
Number of Patients With Release of Interferon-Gamma by T Cells in Response to Cancer Antigens Month 12: CD8 · Negative	3 Participants

SECONDARY outcome

Timeframe: Up to 20 months

NY-ESO-1-specific CD8+ T cells (human leukocyte antigen \[HLA\]-A2 patients only) and NY-ESO-1-specific CD4+ T cells (HLA-DP4 patients only) were measured by interferon-gamma enzyme-linked immunosorbent spot (ELISPOT) assay. The response to the ELISPOT assay was considered to be positive if the number of spots in the peptide-exposed well was 2-fold or more higher than the number of spots in the unstimulated well, and if there was a minimum of 10 (after subtraction of background spots) peptide-specific spots/25,000 T-cells, or less if T-cell clones were used.

Outcome measures

Outcome measures
Measure	rV- and rF-NY-ESO-1 n=22 Participants Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10\^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10\^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
Number of Patients With Detectable T-cell Responses Following Vaccination Detectable CD4+ T-cell response	20 Participants
Number of Patients With Detectable T-cell Responses Following Vaccination Detectable CD8+ T-cell response	10 Participants

SECONDARY outcome

Timeframe: Up to 6 months

NY-ESO-1 antigen-specific delayed-type hypersensitivity (DTH) was measured by skin test at Screening and on Days 113 and 197. All patients were tested for the NY-ESO-1 protein, with additional DTH testing as follows: patients who were HLA-A2+ had NY-ESO-1b testing, patients who were HLA-DP4+ had NY-ESO-DP4 testing, and patients who were both HLA-A2+ and HLA-DP4+ had NY-ESO-1b and NY-ESO-DP4 testing.

Outcome measures

Outcome measures
Measure	rV- and rF-NY-ESO-1 n=22 Participants Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10\^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10\^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
Number of Patients With Delayed-Type Hypersensitivity Reactions Following Vaccination NY-ESO-1 protein: Induration at Screening	1 Participants
Number of Patients With Delayed-Type Hypersensitivity Reactions Following Vaccination NY-ESO-1 protein: Redness at Screening	5 Participants
Number of Patients With Delayed-Type Hypersensitivity Reactions Following Vaccination NY-ESO-1 protein: Induration at Day 113	1 Participants
Number of Patients With Delayed-Type Hypersensitivity Reactions Following Vaccination NY-ESO-1 protein: Redness at Day 113	4 Participants
Number of Patients With Delayed-Type Hypersensitivity Reactions Following Vaccination NY-ESO-1 protein: Induration at Day 197	0 Participants
Number of Patients With Delayed-Type Hypersensitivity Reactions Following Vaccination NY-ESO-1 protein: Redness at Day 197	1 Participants
Number of Patients With Delayed-Type Hypersensitivity Reactions Following Vaccination NY-ESO-1b: Induration at Screening	1 Participants
Number of Patients With Delayed-Type Hypersensitivity Reactions Following Vaccination NY-ESO-1b: Redness at Screening	1 Participants
Number of Patients With Delayed-Type Hypersensitivity Reactions Following Vaccination NY-ESO-1b: Induration at Day 113	0 Participants
Number of Patients With Delayed-Type Hypersensitivity Reactions Following Vaccination NY-ESO-1b: Redness at Day 113	0 Participants
Number of Patients With Delayed-Type Hypersensitivity Reactions Following Vaccination NY-ESO-1b: Induration at Day 197	0 Participants
Number of Patients With Delayed-Type Hypersensitivity Reactions Following Vaccination NY-ESO-1b: Redness at Day 197	0 Participants
Number of Patients With Delayed-Type Hypersensitivity Reactions Following Vaccination NY-ESO-DP4: Induration at Screening	0 Participants
Number of Patients With Delayed-Type Hypersensitivity Reactions Following Vaccination NY-ESO-DP4: Redness at Screening	2 Participants
Number of Patients With Delayed-Type Hypersensitivity Reactions Following Vaccination NY-ESO-DP4: Induration at Day 113	0 Participants
Number of Patients With Delayed-Type Hypersensitivity Reactions Following Vaccination NY-ESO-DP4: Redness at Day 113	0 Participants
Number of Patients With Delayed-Type Hypersensitivity Reactions Following Vaccination NY-ESO-DP4: Induration at Day 197	0 Participants
Number of Patients With Delayed-Type Hypersensitivity Reactions Following Vaccination NY-ESO-DP4: Redness at Day 197	0 Participants

SECONDARY outcome

Timeframe: Continuously for up to 20 months

Population: The Safety Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1.

Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), 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.

Outcome measures

Outcome measures
Measure	rV- and rF-NY-ESO-1 n=23 Participants Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10\^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10\^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
Number of Patients With Treatment-emergent Adverse Events Any TEAE	23 Participants
Number of Patients With Treatment-emergent Adverse Events Maximum grade 1 TEAE	3 Participants
Number of Patients With Treatment-emergent Adverse Events Maximum grade 2 TEAE	15 Participants
Number of Patients With Treatment-emergent Adverse Events Maximum grade 3 TEAE	3 Participants
Number of Patients With Treatment-emergent Adverse Events Maximum grade 4 TEAE	2 Participants
Number of Patients With Treatment-emergent Adverse Events Treatment-related TEAE	9 Participants
Number of Patients With Treatment-emergent Adverse Events Serious TEAE	4 Participants
Number of Patients With Treatment-emergent Adverse Events TEAE Leading to Treatment Discontinuation	2 Participants

Adverse Events

rV- and rF-NY-ESO-1

Serious events: 4 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	rV- and rF-NY-ESO-1 n=23 participants at risk Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10\^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10\^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
Infections and infestations Urinary tract infection	4.3% 1/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Musculoskeletal and connective tissue disorders Pathological fracture	4.3% 1/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Gastrointestinal disorders Small intestinal obstruction	4.3% 1/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	4.3% 1/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Gastrointestinal disorders Abdominal pain	4.3% 1/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Cough	4.3% 1/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Psychiatric disorders Mental status changes	4.3% 1/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Infections and infestations Pneumonia	4.3% 1/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Respiratory failure	4.3% 1/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Infections and infestations Septic shock	4.3% 1/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.

Other adverse events

Other adverse events
Measure	rV- and rF-NY-ESO-1 n=23 participants at risk Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10\^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10\^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
Gastrointestinal disorders Abdominal pain	17.4% 4/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Gastrointestinal disorders Abdominal pain upper	17.4% 4/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Gastrointestinal disorders Nausea	17.4% 4/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Gastrointestinal disorders Vomiting	13.0% 3/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Gastrointestinal disorders Abdominal distension	8.7% 2/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Gastrointestinal disorders Diarrhoea	8.7% 2/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
General disorders Chest pain	13.0% 3/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
General disorders Pyrexia	13.0% 3/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
General disorders Fatigue	8.7% 2/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
General disorders Injection site pruritus	8.7% 2/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
General disorders Injection site reaction	8.7% 2/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
General disorders Injection site scab	8.7% 2/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
General disorders Oedema peripheral	8.7% 2/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
General disorders Pain	8.7% 2/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Infections and infestations Nasopharyngitis	17.4% 4/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Infections and infestations Urinary tract infection	8.7% 2/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Infections and infestations Bronchitis	8.7% 2/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Infections and infestations Sinusitis	8.7% 2/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Investigations Skin test positive	87.0% 20/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Investigations Blood creatinine increased	8.7% 2/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Investigations Blood glucose increased	8.7% 2/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Investigations Blood urea increased	8.7% 2/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Metabolism and nutrition disorders Hyperkalaemia	8.7% 2/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Metabolism and nutrition disorders Hyponatraemia	8.7% 2/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Musculoskeletal and connective tissue disorders Back pain	17.4% 4/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Musculoskeletal and connective tissue disorders Arthralgia	8.7% 2/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Musculoskeletal and connective tissue disorders Muscle spasms	8.7% 2/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Musculoskeletal and connective tissue disorders Pain in extremity	8.7% 2/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Nervous system disorders Neuropathy peripheral	13.0% 3/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Nervous system disorders Dizziness	8.7% 2/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Nervous system disorders Headache	8.7% 2/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Psychiatric disorders Insomnia	13.0% 3/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Renal and urinary disorders Pollakiuria	8.7% 2/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Reproductive system and breast disorders Breast tenderness	8.7% 2/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Cough	17.4% 4/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Dyspnoea	13.0% 3/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Nasal congestion	13.0% 3/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Respiratory, thoracic and mediastinal disorders Wheezing	8.7% 2/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.
Skin and subcutaneous tissue disorders Rash	13.0% 3/23 • All adverse events (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 20 months. AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, 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 patient at the maximum reported grade.

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