Trial Outcomes & Findings for NY-ESO-1 Protein Vaccine With Imiquimod in Melanoma (Adjuvant Setting) (NCT NCT00142454)
NCT ID: NCT00142454
Last Updated: 2022-10-10
Results Overview
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, as follows: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), and Grade 5 (fatal). Adverse events (AEs) were reported based on clinical laboratory tests, vital sign and weight measurements, physical examinations, performance status evaluations, and any other medically indicated assessments, including patient interviews, from the time informed consent was signed through the last follow-up visit. AEs were considered to be treatment emergent (TEAE) if they occurred or worsened in severity after the first dose of study treatment.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
Up to 4 months
Results posted on
2022-10-10
Participant Flow
Participant milestones
| Measure |
Imiquimod + NY-ESO-1
Patients applied topical imiquimod cream (250 mg) to a designated area of healthy skin on the upper inner arm or inner thigh (the cream remained on the skin overnight for 6-10 hours) every day for 5 consecutive days (i.e., for the first 5 days of Cycles 1-3 and for the first 4 days of Cycle 4). A vaccination with the NY-ESO-1 protein (100 μg) was injected intradermally into the imiquimod-pretreated area on Day 3 of each cycle for 4 consecutive 21-day cycles.
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|---|---|
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Overall Study
STARTED
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9
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Overall Study
COMPLETED
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9
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
NY-ESO-1 Protein Vaccine With Imiquimod in Melanoma (Adjuvant Setting)
Baseline characteristics by cohort
| Measure |
Imiquimod + NY-ESO-1
n=9 Participants
Patients applied topical imiquimod cream (250 mg) to a designated area of healthy skin on the upper inner arm or inner thigh (the cream remained on the skin overnight for 6-10 hours) every day for 5 consecutive days (i.e., for the first 5 days of Cycles 1-3 and for the first 4 days of Cycle 4). A vaccination with the NY-ESO-1 protein (100 μg) was injected intradermally into the imiquimod-pretreated area on Day 3 of each cycle for 4 consecutive 21-day cycles.
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|---|---|
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Age, Continuous
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49 years
n=5 Participants
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Sex: Female, Male
Female
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7 Participants
n=5 Participants
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Sex: Female, Male
Male
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2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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8 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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8 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=5 Participants
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Region of Enrollment
United States
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9 Participants
n=5 Participants
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Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0
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9 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Up to 4 monthsPopulation: The population comprises all patients who received any dose of study treatment.
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, as follows: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), and Grade 5 (fatal). Adverse events (AEs) were reported based on clinical laboratory tests, vital sign and weight measurements, physical examinations, performance status evaluations, and any other medically indicated assessments, including patient interviews, from the time informed consent was signed through the last follow-up visit. AEs were considered to be treatment emergent (TEAE) if they occurred or worsened in severity after the first dose of study treatment.
Outcome measures
| Measure |
Imiquimod + NY-ESO-1
n=9 Participants
Patients applied topical imiquimod cream (250 mg) to a designated area of healthy skin on the upper inner arm or inner thigh (the cream remained on the skin overnight for 6-10 hours) every day for 5 consecutive days (i.e., for the first 5 days of Cycles 1-3 and for the first 4 days of Cycle 4). A vaccination with the NY-ESO-1 protein (100 μg) was injected intradermally into the imiquimod-pretreated area on Day 3 of each cycle for 4 consecutive 21-day cycles.
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|---|---|
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Number of Patients With Treatment-emergent Adverse Events (TEAEs)
Any TEAE
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8 Participants
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Number of Patients With Treatment-emergent Adverse Events (TEAEs)
Maximum TEAE severity Grade 1
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8 Participants
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Number of Patients With Treatment-emergent Adverse Events (TEAEs)
Serious TEAE
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0 Participants
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Number of Patients With Treatment-emergent Adverse Events (TEAEs)
TEAE leading to discontinuation
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0 Participants
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SECONDARY outcome
Timeframe: Up to 4 monthsPopulation: The population comprises all patients who received any dose of study treatment.
Assays to assess cluster of differentiation (CD)8+ and CD4+ antigen-specific responses were performed at baseline (Cycle 1 Day 1), throughout the vaccination period (Day 1 of Cycles 2 through 4 and Day 10 of each cycle), and at the 2 post-treatment follow-up visits (Weeks 13 and 16) by enzyme-linked immune absorbent spot (ELISPOT) assay following prior in vitro sensitization. A 3-fold increase in spot-forming cells over baseline defined a positive response. Suitable antigens may have included recombinant viral vectors encoding NY-ESO-1, or NY-ESO-1 overlapping peptides, depending upon availability.
Outcome measures
| Measure |
Imiquimod + NY-ESO-1
n=9 Participants
Patients applied topical imiquimod cream (250 mg) to a designated area of healthy skin on the upper inner arm or inner thigh (the cream remained on the skin overnight for 6-10 hours) every day for 5 consecutive days (i.e., for the first 5 days of Cycles 1-3 and for the first 4 days of Cycle 4). A vaccination with the NY-ESO-1 protein (100 μg) was injected intradermally into the imiquimod-pretreated area on Day 3 of each cycle for 4 consecutive 21-day cycles.
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|---|---|
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Number of Patients With Cellular Antibody Response to NY-ESO-1 at Two or More Post-vaccination Time Points
CD4+ T cell response
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7 Participants
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Number of Patients With Cellular Antibody Response to NY-ESO-1 at Two or More Post-vaccination Time Points
CD8+ T cell response
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0 Participants
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SECONDARY outcome
Timeframe: Up to 4 monthsPopulation: The population comprises all patients who received any dose of study treatment.
Assays to assess NY-ESO-1 specific antibodies were performed at baseline (Cycle 1 Day 1), throughout the vaccination period (Day 1 of Cycles 2 through 4 and Day 10 of each cycle), and at the 2 post-treatment follow-up visits (Weeks 13 and 16) by enzyme-linked immunosorbent assay (ELISA). Samples were diluted serially. The induction and augmentation of immunity were defined as an increase in antibody titer of ≥ 3× over buffer alone or ≥ 4× the pre-vaccination titer, respectively. Sera from the responding patients were tested a second time against a pool of NY-ESO-1 overlapping peptides to confirm NY-ESO-1 specificity; the number of patients in the table reflect the patients with confirmed NY-ESO-1 specificity.
Outcome measures
| Measure |
Imiquimod + NY-ESO-1
n=9 Participants
Patients applied topical imiquimod cream (250 mg) to a designated area of healthy skin on the upper inner arm or inner thigh (the cream remained on the skin overnight for 6-10 hours) every day for 5 consecutive days (i.e., for the first 5 days of Cycles 1-3 and for the first 4 days of Cycle 4). A vaccination with the NY-ESO-1 protein (100 μg) was injected intradermally into the imiquimod-pretreated area on Day 3 of each cycle for 4 consecutive 21-day cycles.
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Number of Patients With Humoral Antibody Response to NY-ESO-1
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4 Participants
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Adverse Events
Imiquimod + NY-ESO-1
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Imiquimod + NY-ESO-1
n=9 participants at risk
Patients applied topical imiquimod cream (250 mg) to a designated area of healthy skin on the upper inner arm or inner thigh (the cream remained on the skin overnight for 6-10 hours) every day for 5 consecutive days (i.e., for the first 5 days of Cycles 1-3 and for the first 4 days of Cycle 4). A vaccination with the NY-ESO-1 protein (100 μg) was injected intradermally into the imiquimod-pretreated area on Day 3 of each cycle for 4 consecutive 21-day cycles.
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General disorders
Redness at injection site
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66.7%
6/9 • All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), frequency, seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
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General disorders
Swelling at injection site
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22.2%
2/9 • All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), frequency, seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
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General disorders
Pain at injection site
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11.1%
1/9 • All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), frequency, seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
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General disorders
Splotchy at injection site
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11.1%
1/9 • All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), frequency, seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
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General disorders
Edema
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11.1%
1/9 • All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), frequency, seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
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Skin and subcutaneous tissue disorders
Boils
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11.1%
1/9 • All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), frequency, seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
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Skin and subcutaneous tissue disorders
Pruritus
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11.1%
1/9 • All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), frequency, seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
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Cardiac disorders
Irregular heart rate
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11.1%
1/9 • All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), frequency, seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
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Infections and infestations
Staph infection
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11.1%
1/9 • All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), frequency, seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
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General disorders
Fatigue
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44.4%
4/9 • All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), frequency, seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
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General disorders
Tenderness on heel
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11.1%
1/9 • All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), frequency, seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
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General disorders
Itching at injection site
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11.1%
1/9 • All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), frequency, seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
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General disorders
Burning in groin area
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11.1%
1/9 • All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), frequency, seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
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Infections and infestations
Urinary tract infection
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11.1%
1/9 • All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), frequency, seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
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Musculoskeletal and connective tissue disorders
Shoulder pain
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11.1%
1/9 • All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), frequency, seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
General disorders
Hardness at injection site
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11.1%
1/9 • All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), frequency, seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
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General disorders
Flu-like symptoms
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22.2%
2/9 • All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), frequency, seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Infections and infestations
Respiration infection
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11.1%
1/9 • All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), frequency, seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
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General disorders
Injection site reaction
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22.2%
2/9 • All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), frequency, seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Psychiatric disorders
Difficulty sleeping
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11.1%
1/9 • All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), frequency, seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Thigh pimple
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11.1%
1/9 • All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), frequency, seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
General disorders
Mouth sores
|
11.1%
1/9 • All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), frequency, seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
1/9 • All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), frequency, seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Itching shoulder scar
|
11.1%
1/9 • All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), frequency, seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Redness on thigh
|
11.1%
1/9 • All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), frequency, seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
General disorders
Flu shot reaction
|
11.1%
1/9 • All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), frequency, seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Redness on arm
|
11.1%
1/9 • All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), frequency, seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
General disorders
Leg edema
|
11.1%
1/9 • All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), frequency, seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
|
|
General disorders
Fever
|
11.1%
1/9 • All adverse events (AEs), regardless of causality to study drug, were documented from informed consent through the final follow-up visit, which was up to 4 months for each patient.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), frequency, seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms were counted only once per patient at the maximum reported grade.
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Additional Information
Jonathan Skipper PhD
Ludwig Institute for Cancer Research
Phone: (212) 450-1539
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60