Trial Outcomes & Findings for Neoantigen DNA Vaccine in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy (NCT NCT03122106)
NCT ID: NCT03122106
Last Updated: 2023-10-10
Results Overview
* Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 * Related indicates possibly, probably, or definitely related to the study treatment
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Through week 24
Results posted on
2023-10-10
Participant Flow
Participant milestones
| Measure |
Personalized Neoantigen DNA Vaccine
* Vaccines will be weeks 1, 5, 9, 13, 17, and 21. Vaccines will occur within +/- 1 week with at least 3 weeks between vaccines. All study injections will be given intramuscularly using TDS-IM system. At each vaccination time point, patients will receive 2 injections of the neoantigen DNA vaccine, 1 injection into each deltoid or lateralis.
* Minimum observation of 30 minutes. Vital signs will be taken at 30-45 minutes post-immunization. The injection sites will be inspected for evidence of local reaction. Follow up on subject well-being will be performed by telephone on the 1st or 2nd day following each injection. -Post-vaccination follow-up visits are at Week 25 ± 7 days and Week 77 ± 14 days. Additional follow-up visits or telephone contact will be scheduled at Week 129 and annually thereafter if the patient is alive and available for follow-up.
* At intervals throughout the study (both before and after vaccination) subjects will have blood drawn for immunologic assays.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Personalized Neoantigen DNA Vaccine
* Vaccines will be weeks 1, 5, 9, 13, 17, and 21. Vaccines will occur within +/- 1 week with at least 3 weeks between vaccines. All study injections will be given intramuscularly using TDS-IM system. At each vaccination time point, patients will receive 2 injections of the neoantigen DNA vaccine, 1 injection into each deltoid or lateralis.
* Minimum observation of 30 minutes. Vital signs will be taken at 30-45 minutes post-immunization. The injection sites will be inspected for evidence of local reaction. Follow up on subject well-being will be performed by telephone on the 1st or 2nd day following each injection. -Post-vaccination follow-up visits are at Week 25 ± 7 days and Week 77 ± 14 days. Additional follow-up visits or telephone contact will be scheduled at Week 129 and annually thereafter if the patient is alive and available for follow-up.
* At intervals throughout the study (both before and after vaccination) subjects will have blood drawn for immunologic assays.
|
|---|---|
|
Overall Study
Not enough tissue
|
1
|
|
Overall Study
Disease progression during screening
|
2
|
|
Overall Study
Poor RNA quality for vaccine
|
1
|
Baseline Characteristics
Neoantigen DNA Vaccine in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy
Baseline characteristics by cohort
| Measure |
Personalized Neoantigen DNA Vaccine
n=15 Participants
* Vaccines will be weeks 1, 5, 9, 13, 17, and 21. Vaccines will occur within +/- 1 week with at least 3 weeks between vaccines. All study injections will be given intramuscularly using TDS-IM system. At each vaccination time point, patients will receive 2 injections of the neoantigen DNA vaccine, 1 injection into each deltoid or lateralis.
* Minimum observation of 30 minutes. Vital signs will be taken at 30-45 minutes post-immunization. The injection sites will be inspected for evidence of local reaction. Follow up on subject well-being will be performed by telephone on the 1st or 2nd day following each injection. -Post-vaccination follow-up visits are at Week 25 ± 7 days and Week 77 ± 14 days. Additional follow-up visits or telephone contact will be scheduled at Week 129 and annually thereafter if the patient is alive and available for follow-up.
* At intervals throughout the study (both before and after vaccination) subjects will have blood drawn for immunologic assays.
|
|---|---|
|
Age, Continuous
|
67 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Through week 24* Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 * Related indicates possibly, probably, or definitely related to the study treatment
Outcome measures
| Measure |
Personalized Neoantigen DNA Vaccine
n=11 Participants
* Vaccines will be weeks 1, 5, 9, 13, 17, and 21. Vaccines will occur within +/- 1 week with at least 3 weeks between vaccines. All study injections will be given intramuscularly using TDS-IM system. At each vaccination time point, patients will receive 2 injections of the neoantigen DNA vaccine, 1 injection into each deltoid or lateralis.
* Minimum observation of 30 minutes. Vital signs will be taken at 30-45 minutes post-immunization. The injection sites will be inspected for evidence of local reaction. Follow up on subject well-being will be performed by telephone on the 1st or 2nd day following each injection. -Post-vaccination follow-up visits are at Week 25 ± 7 days and Week 77 ± 14 days. Additional follow-up visits or telephone contact will be scheduled at Week 129 and annually thereafter if the patient is alive and available for follow-up.
* At intervals throughout the study (both before and after vaccination) subjects will have blood drawn for immunologic assays.
|
|---|---|
|
Safety of Neoantigen DNA Vaccine as Measured by the Number of Subjects Experiencing Each Type of Treatment-related Adverse Event
Abdominal pain
|
1 Participants
|
|
Safety of Neoantigen DNA Vaccine as Measured by the Number of Subjects Experiencing Each Type of Treatment-related Adverse Event
Bruising
|
1 Participants
|
|
Safety of Neoantigen DNA Vaccine as Measured by the Number of Subjects Experiencing Each Type of Treatment-related Adverse Event
Chills
|
1 Participants
|
|
Safety of Neoantigen DNA Vaccine as Measured by the Number of Subjects Experiencing Each Type of Treatment-related Adverse Event
Conjunctivitis
|
1 Participants
|
|
Safety of Neoantigen DNA Vaccine as Measured by the Number of Subjects Experiencing Each Type of Treatment-related Adverse Event
Fatigue
|
2 Participants
|
|
Safety of Neoantigen DNA Vaccine as Measured by the Number of Subjects Experiencing Each Type of Treatment-related Adverse Event
Fever
|
1 Participants
|
|
Safety of Neoantigen DNA Vaccine as Measured by the Number of Subjects Experiencing Each Type of Treatment-related Adverse Event
Injection site pain
|
10 Participants
|
|
Safety of Neoantigen DNA Vaccine as Measured by the Number of Subjects Experiencing Each Type of Treatment-related Adverse Event
Injection site reaction
|
2 Participants
|
|
Safety of Neoantigen DNA Vaccine as Measured by the Number of Subjects Experiencing Each Type of Treatment-related Adverse Event
Hypertension
|
1 Participants
|
|
Safety of Neoantigen DNA Vaccine as Measured by the Number of Subjects Experiencing Each Type of Treatment-related Adverse Event
Muscle soreness
|
1 Participants
|
|
Safety of Neoantigen DNA Vaccine as Measured by the Number of Subjects Experiencing Each Type of Treatment-related Adverse Event
Myalgia
|
10 Participants
|
|
Safety of Neoantigen DNA Vaccine as Measured by the Number of Subjects Experiencing Each Type of Treatment-related Adverse Event
Nausea
|
1 Participants
|
|
Safety of Neoantigen DNA Vaccine as Measured by the Number of Subjects Experiencing Each Type of Treatment-related Adverse Event
Pain
|
1 Participants
|
SECONDARY outcome
Timeframe: Through week 77Population: Participants who are not included in this outcome measure include one who did not have enough tissue, one who had poor quality RNA and a vaccine could not be developed, and 2 who developed disease progression.
Immunogenicity is defined as the number of participants with a neoantigen-specific immune response measured by ELISPOT analysis. A participant is considered a responder if there is a significant increase in the number of neoantigen-specific T cells to at least one neoantigen after vaccination. A significant increase is based on t-test comparing the number of neoantigen-specific T-cells before and after vaccination with p=0.05 for significance.
Outcome measures
| Measure |
Personalized Neoantigen DNA Vaccine
n=9 Participants
* Vaccines will be weeks 1, 5, 9, 13, 17, and 21. Vaccines will occur within +/- 1 week with at least 3 weeks between vaccines. All study injections will be given intramuscularly using TDS-IM system. At each vaccination time point, patients will receive 2 injections of the neoantigen DNA vaccine, 1 injection into each deltoid or lateralis.
* Minimum observation of 30 minutes. Vital signs will be taken at 30-45 minutes post-immunization. The injection sites will be inspected for evidence of local reaction. Follow up on subject well-being will be performed by telephone on the 1st or 2nd day following each injection. -Post-vaccination follow-up visits are at Week 25 ± 7 days and Week 77 ± 14 days. Additional follow-up visits or telephone contact will be scheduled at Week 129 and annually thereafter if the patient is alive and available for follow-up.
* At intervals throughout the study (both before and after vaccination) subjects will have blood drawn for immunologic assays.
|
|---|---|
|
Immunogenicity of the Neoantigen DNA Vaccine as Measured by ELISPOT Analysis
|
9 Participants
|
SECONDARY outcome
Timeframe: Through week 77Population: The multiparametric flow cytometry assay described in the protocol was not sufficiently sensitive to reliably detect neoantigen-specific T cell responses. Additional flow cytometry assays are being performed as an exploratory objective.
Outcome measures
Outcome data not reported
Adverse Events
Personalized Neoantigen DNA Vaccine
Serious events: 0 serious events
Other events: 11 other events
Deaths: 5 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Personalized Neoantigen DNA Vaccine
n=11 participants at risk
* Vaccines will be weeks 1, 5, 9, 13, 17, and 21. Vaccines will occur within +/- 1 week with at least 3 weeks between vaccines. All study injections will be given intramuscularly using TDS-IM system. At each vaccination time point, patients will receive 2 injections of the neoantigen DNA vaccine, 1 injection into each deltoid or lateralis.
* Minimum observation of 30 minutes. Vital signs will be taken at 30-45 minutes post-immunization. The injection sites will be inspected for evidence of local reaction. Follow up on subject well-being will be performed by telephone on the 1st or 2nd day following each injection. -Post-vaccination follow-up visits are at Week 25 ± 7 days and Week 77 ± 14 days. Additional follow-up visits or telephone contact will be scheduled at Week 129 and annually thereafter if the patient is alive and available for follow-up.
* At intervals throughout the study (both before and after vaccination) subjects will have blood drawn for immunologic assays.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
27.3%
3/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Blood and lymphatic system disorders
Iron deficient anemia
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Eye disorders
Conjunctivitis
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Gastrointestinal disorders
Abdominal distension
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Gastrointestinal disorders
Abdominal pain
|
27.3%
3/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Gastrointestinal disorders
Colitis
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
2/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
General disorders
Chills
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
General disorders
Edema limbs
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
General disorders
Fatigue
|
18.2%
2/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
General disorders
Fever
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
General disorders
Flu like symptoms
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
General disorders
Injection site pain
|
90.9%
10/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
General disorders
Injection site reaction
|
18.2%
2/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
General disorders
Pain
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Infections and infestations
Sinusitis
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Injury, poisoning and procedural complications
Bruising
|
18.2%
2/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Investigations
Alanine aminotransferase increased
|
18.2%
2/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Investigations
Aspartate aminotransferase increased
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Investigations
Creatinine increased
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Investigations
Lymphocyte count decreased
|
18.2%
2/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
27.3%
3/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Musculoskeletal and connective tissue disorders
Bilateral lower extremity cramping
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Musculoskeletal and connective tissue disorders
Muscle soreness
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
90.9%
10/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Nervous system disorders
Vasovagal reaction
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Psychiatric disorders
Anxiety
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Vascular disorders
Cold sweats
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Vascular disorders
Hot flashes
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Vascular disorders
Hypertension
|
54.5%
6/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Vascular disorders
Hypotension
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
|
Vascular disorders
Thromboembolic event
|
9.1%
1/11 • Adverse events were collected from start of treatment through 24 weeks. All-cause mortality was collected from start of treatment through completion of follow-up (estimated to be 73 weeks).
|
Additional Information
William Gillanders, M.D.
Washington University School of Medicine
Phone: 314-747-0072
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place