Trial Outcomes & Findings for MUC1 Vaccine in Preventing Lung Cancer in Current and Former Smokers at High Risk for Lung Cancer (NCT NCT03300817)
NCT ID: NCT03300817
Last Updated: 2025-06-12
Results Overview
Will be evaluated by monitoring changes in IgG anti-MUC1 antibody titer ratio; defined as t12/t0, where t0 is the "initial titer" measured prior to vaccination, and t12 is the "final titer" drawn at 12 weeks. A titer ratio of \>= 2 will be considered a positive response.
ACTIVE_NOT_RECRUITING
PHASE1
50 participants
At week 12
2025-06-12
Participant Flow
1 patient withdrew prior to beginning treatment and has been removed from all analyses
Participant milestones
| Measure |
Prevention (MUC1 Peptide-Poly-ICLC Vaccine)
Patients receive MUC1 peptide-Poly-ICLC vaccine SC at weeks 0, 2, and 10.
Laboratory Biomarker Analysis: Correlative studies
MUC1 Peptide-Poly-ICLC Vaccine: Given SC
|
|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Prevention (MUC1 Peptide-Poly-ICLC Vaccine)
Patients receive MUC1 peptide-Poly-ICLC vaccine SC at weeks 0, 2, and 10.
Laboratory Biomarker Analysis: Correlative studies
MUC1 Peptide-Poly-ICLC Vaccine: Given SC
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Subject Found to be Ineligible
|
2
|
Baseline Characteristics
MUC1 Vaccine in Preventing Lung Cancer in Current and Former Smokers at High Risk for Lung Cancer
Baseline characteristics by cohort
| Measure |
Prevention (MUC1 Peptide-Poly-ICLC Vaccine)
n=49 Participants
Patients receive MUC1 peptide-Poly-ICLC vaccine SC at weeks 0, 2, and 10.
Laboratory Biomarker Analysis: Correlative studies
MUC1 Peptide-Poly-ICLC Vaccine: Given SC
|
|---|---|
|
Age, Continuous
|
67.4 years
STANDARD_DEVIATION 4.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
48 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
|
|
Smoking Status
Current Smoker
|
29 Participants
n=5 Participants
|
|
Smoking Status
Former Smoker
|
20 Participants
n=5 Participants
|
|
Weight
|
83.1 kg
STANDARD_DEVIATION 19.47 • n=5 Participants
|
PRIMARY outcome
Timeframe: At week 12Population: 4 patients are excluded from this analysis because they did not receive injections at weeks 2 and 10
Will be evaluated by monitoring changes in IgG anti-MUC1 antibody titer ratio; defined as t12/t0, where t0 is the "initial titer" measured prior to vaccination, and t12 is the "final titer" drawn at 12 weeks. A titer ratio of \>= 2 will be considered a positive response.
Outcome measures
| Measure |
Prevention (MUC1 Peptide-Poly-ICLC Vaccine)
n=45 Participants
Patients receive MUC1 peptide-Poly-ICLC vaccine SC at weeks 0, 2, and 10.
Laboratory Biomarker Analysis: Correlative studies
MUC1 Peptide-Poly-ICLC Vaccine: Given SC
|
Former Smoker
Patients that no longer smoke, but did in the past
|
|---|---|---|
|
Number of Participants With Immunogenicity of the MUC1 Vaccine
|
13.3 percentage of participants
Interval 5.1 to 26.8
|
—
|
PRIMARY outcome
Timeframe: 24 weeksWill be assessed according to National Cancer Institute Common Toxicity Criteria version 4.0. The maximum grade for each type of adverse event will be recorded for each participant and frequency tables will be reviewed to determine the overall patterns. In addition, the number and severity of adverse events will be tabulated and summarized across all grades.
Outcome measures
| Measure |
Prevention (MUC1 Peptide-Poly-ICLC Vaccine)
n=49 Participants
Patients receive MUC1 peptide-Poly-ICLC vaccine SC at weeks 0, 2, and 10.
Laboratory Biomarker Analysis: Correlative studies
MUC1 Peptide-Poly-ICLC Vaccine: Given SC
|
Former Smoker
Patients that no longer smoke, but did in the past
|
|---|---|---|
|
Count of Patients Experiencing 1 or More Grade 3+ Adverse Events at Least Possibly Related to Treatment
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: 12 weeksTo explore potential differences, if any, in the immunogenicity of the vaccine (as assessed at week 12 by the IgG anti-MUC1 antibody titer ratio) in current vs. former smokers.
Outcome measures
| Measure |
Prevention (MUC1 Peptide-Poly-ICLC Vaccine)
n=27 Participants
Patients receive MUC1 peptide-Poly-ICLC vaccine SC at weeks 0, 2, and 10.
Laboratory Biomarker Analysis: Correlative studies
MUC1 Peptide-Poly-ICLC Vaccine: Given SC
|
Former Smoker
n=18 Participants
Patients that no longer smoke, but did in the past
|
|---|---|---|
|
Effect of Smoking Status on Vaccine Response
|
4 participants that responded to vaccine
|
2 participants that responded to vaccine
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Only patients with available data on levels of circulating myeloid derived suppressor cells at 12 weeks are included
Will correlate with the ability to respond to the vaccine. Will summarize the data using descriptive statistics and graphical methods (i.e. boxplots, scatter plots, etc.). For continuous MDSC data versus response data, will use t-tests or Wilcoxon Rank-Sum tests (for non-normal data).
Outcome measures
| Measure |
Prevention (MUC1 Peptide-Poly-ICLC Vaccine)
n=39 Participants
Patients receive MUC1 peptide-Poly-ICLC vaccine SC at weeks 0, 2, and 10.
Laboratory Biomarker Analysis: Correlative studies
MUC1 Peptide-Poly-ICLC Vaccine: Given SC
|
Former Smoker
n=6 Participants
Patients that no longer smoke, but did in the past
|
|---|---|---|
|
Pre-Vaccination Levels Versus Post-Vaccination Levels of Circulating Myeloid Derived Suppressor Cells (MDSC)
|
13.9 percent CD33
Interval 1.4 to 37.9
|
9.4 percent CD33
Interval 5.7 to 27.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 12Will explore the relationship between COPD status at pre-registration and immune response in current versus former smokers. In individuals with COPD, the severity of airflow obstruction will be measured by the pulmonary function tests as per the GOLD classification.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to week 12Will explore whether or not changes in immunogenicity in individuals with COPD corresponds to different circulating MDSC levels.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to week 24Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to week 24Outcome measures
Outcome data not reported
Adverse Events
Prevention (MUC1 Peptide-Poly-ICLC Vaccine)
Serious adverse events
| Measure |
Prevention (MUC1 Peptide-Poly-ICLC Vaccine)
n=49 participants at risk
Patients receive MUC1 peptide-Poly-ICLC vaccine SC at weeks 0, 2, and 10.
Laboratory Biomarker Analysis: Correlative studies
MUC1 Peptide-Poly-ICLC Vaccine: Given SC
|
|---|---|
|
Renal and urinary disorders
Hematuria
|
2.0%
1/49 • 24 weeks
|
|
Infections and infestations
Tooth infection
|
2.0%
1/49 • 24 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
1/49 • 24 weeks
|
Other adverse events
| Measure |
Prevention (MUC1 Peptide-Poly-ICLC Vaccine)
n=49 participants at risk
Patients receive MUC1 peptide-Poly-ICLC vaccine SC at weeks 0, 2, and 10.
Laboratory Biomarker Analysis: Correlative studies
MUC1 Peptide-Poly-ICLC Vaccine: Given SC
|
|---|---|
|
Metabolism and nutrition disorders
Acidosis
|
2.0%
1/49 • 24 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
2.0%
1/49 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
2.0%
1/49 • 24 weeks
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.0%
1/49 • 24 weeks
|
|
General disorders
Non-cardiac chest pain
|
2.0%
1/49 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
2.0%
1/49 • 24 weeks
|
|
Infections and infestations
Tooth infection
|
2.0%
1/49 • 24 weeks
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
2.0%
1/49 • 24 weeks
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/49 • 24 weeks
|
|
Infections and infestations
Upper respiratory infection
|
8.2%
4/49 • 24 weeks
|
|
Nervous system disorders
Transient ischemic attacks
|
2.0%
1/49 • 24 weeks
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
6.1%
3/49 • 24 weeks
|
|
Infections and infestations
Skin infection
|
2.0%
1/49 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
2.0%
1/49 • 24 weeks
|
|
Investigations
Serum amylase increased
|
10.2%
5/49 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
4.1%
2/49 • 24 weeks
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
2.0%
1/49 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.0%
1/49 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
1/49 • 24 weeks
|
|
Renal and urinary disorders
Proteinuria
|
2.0%
1/49 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.0%
1/49 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
1/49 • 24 weeks
|
|
General disorders
Pain
|
16.3%
8/49 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.0%
1/49 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.0%
1/49 • 24 weeks
|
|
Investigations
Lipase increased
|
10.2%
5/49 • 24 weeks
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.0%
1/49 • 24 weeks
|
|
Investigations
Investigations - Other, specify
|
8.2%
4/49 • 24 weeks
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
2.0%
1/49 • 24 weeks
|
|
General disorders
Injection site reaction
|
75.5%
37/49 • 24 weeks
|
|
Infections and infestations
Infections and infestations - Other, specify
|
4.1%
2/49 • 24 weeks
|
|
Immune system disorders
Immune system disorders - Other, specify
|
2.0%
1/49 • 24 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.1%
2/49 • 24 weeks
|
|
Nervous system disorders
Headache
|
8.2%
4/49 • 24 weeks
|
|
Renal and urinary disorders
Hematuria
|
2.0%
1/49 • 24 weeks
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
10.2%
5/49 • 24 weeks
|
|
Gastrointestinal disorders
Gastritis
|
2.0%
1/49 • 24 weeks
|
|
Investigations
Forced expiratory volume decreased
|
2.0%
1/49 • 24 weeks
|
|
Gastrointestinal disorders
Flu like symptoms
|
2.0%
1/49 • 24 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
1/49 • 24 weeks
|
|
Eye disorders
Eye disorders - Other, specify
|
4.1%
2/49 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.0%
1/49 • 24 weeks
|
|
General disorders
Edema face
|
2.0%
1/49 • 24 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
1/49 • 24 weeks
|
|
Nervous system disorders
Dizziness
|
4.1%
2/49 • 24 weeks
|
|
Investigations
Creatinine increased
|
2.0%
1/49 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/49 • 24 weeks
|
|
Injury, poisoning and procedural complications
Bruising
|
2.0%
1/49 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.0%
1/49 • 24 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
2.0%
1/49 • 24 weeks
|
|
Immune system disorders
Allergic reaction
|
2.0%
1/49 • 24 weeks
|
|
Investigations
Alkaline phosphatase increased
|
2.0%
1/49 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
1/49 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60