Trial Outcomes & Findings for Personalized Immunotherapy in Adults With Advanced Cancers Immunotherapy in Adults With Advanced Cancers (NCT NCT03568058)
NCT ID: NCT03568058
Last Updated: 2026-03-24
Results Overview
Number of Treatment-related Adverse Events
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
1 year
Results posted on
2026-03-24
Participant Flow
Participant milestones
| Measure |
Arm A: Personalized Vaccine and Anti- PD-1 Administered Concurrently at the Start of Study Therapy.
Personalized vaccine and anti- PD-1 administered concurrently at the start of study therapy. Personalized vaccine will be administered by subcutaneous injection. Vaccine will be administered every three weeks for a total of three doses. Vaccine may continue to be administered at 3 week intervals for an additional 9 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit.
Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks.
Pembrolizumab: Pembrolizumab was administered intravenous (IV) infusion every 3 weeks.
|
Arm B: Anti-PD-1 Antibody for 6 Weeks Followed by Personalized Vaccine Therapy.
Anti-PD-1 antibody for 6 weeks followed by personalized vaccine therapy. Personalized vaccine will be administered by subcutaneous injection. Vaccine will be administered every three weeks for a total of three doses. Vaccine may continue to be administered at 3 week intervals for an additional 9 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit.
Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks.
Pembrolizumab: Pembrolizumab was administered intravenous (IV) infusion every 3 weeks.
|
Arm C: Personalized Vaccine & Anti- PD-1 Administered Concurrently in a Boosted Schedule
Personalized vaccine and anti- PD-1 administered concurrently in a boosted schedule at the start of study therapy. Personalized vaccine will be administered by intramuscular injection. Vaccine will be administered three weekly priming vaccine doses, followed by six vaccine doses administered every three weeks. Vaccine may continue to be administered at 3 week intervals for an additional 18 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit.
Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks.
Pembrolizumab: Pembrolizumab was administered intravenous (IV) infusion every 3 weeks.
|
Arm D: Personalized Vaccine Alone, in a Boosted Schedule at the Start of Study Therapy.
Personalized vaccine alone, in a boosted schedule at the start of study therapy. Personalized vaccine will be administered by intramuscular injection. Vaccine will be administered three weekly priming vaccine doses, followed by six vaccine doses administered every three weeks. Vaccine may continue to be administered at 3 week intervals for an additional 18 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit.
Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
0
|
13
|
7
|
|
Overall Study
COMPLETED
|
5
|
0
|
13
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Personalized Immunotherapy in Adults With Advanced Cancers Immunotherapy in Adults With Advanced Cancers
Baseline characteristics by cohort
| Measure |
Arm A: Personalized Vaccine and Anti- PD-1 Administered Concurrently at the Start of Study Therapy.
n=5 Participants
Personalized vaccine and anti- PD-1 administered concurrently at the start of study therapy. Personalized vaccine will be administered by subcutaneous injection. Vaccine will be administered every three weeks for a total of three doses. Vaccine may continue to be administered at 3 week intervals for an additional 9 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit.
Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks.
Pembrolizumab: Pembrolizumab was administered intravenous (IV) infusion every 3 weeks.
|
Arm B: Anti-PD-1 Antibody for 6 Weeks Followed by Personalized Vaccine Therapy.
Anti-PD-1 antibody for 6 weeks followed by personalized vaccine therapy. Personalized vaccine will be administered by subcutaneous injection. Vaccine will be administered every three weeks for a total of three doses. Vaccine may continue to be administered at 3 week intervals for an additional 9 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit.
Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks.
Pembrolizumab: Pembrolizumab was administered intravenous (IV) infusion every 3 weeks.
|
Arm C: Personalized Vaccine & Anti- PD-1 Administered Concurrently in a Boosted Schedule
n=13 Participants
Personalized vaccine and anti- PD-1 administered concurrently in a boosted schedule at the start of study therapy. Personalized vaccine will be administered by intramuscular injection. Vaccine will be administered three weekly priming vaccine doses, followed by six vaccine doses administered every three weeks. Vaccine may continue to be administered at 3 week intervals for an additional 18 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit.
Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks.
Pembrolizumab: Pembrolizumab was administered intravenous (IV) infusion every 3 weeks.
|
Arm D: Personalized Vaccine Alone, in a Boosted Schedule at the Start of Study Therapy.
n=7 Participants
Personalized vaccine alone, in a boosted schedule at the start of study therapy. Personalized vaccine will be administered by intramuscular injection. Vaccine will be administered three weekly priming vaccine doses, followed by six vaccine doses administered every three weeks. Vaccine may continue to be administered at 3 week intervals for an additional 18 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit.
Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.8 Years
STANDARD_DEVIATION 9.31 • n=138 Participants
|
—
|
54 Years
STANDARD_DEVIATION 9.85 • n=123 Participants
|
41.29 Years
STANDARD_DEVIATION 20.32 • n=158 Participants
|
50.6 Years
STANDARD_DEVIATION 14.19 • n=3208 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
5 Participants
n=123 Participants
|
4 Participants
n=158 Participants
|
11 Participants
n=3208 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
8 Participants
n=123 Participants
|
3 Participants
n=158 Participants
|
14 Participants
n=3208 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
2 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
3 Participants
n=3208 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
7 Participants
n=123 Participants
|
7 Participants
n=158 Participants
|
18 Participants
n=3208 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
4 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
4 Participants
n=3208 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=3208 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=3208 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=3208 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=3208 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
10 Participants
n=123 Participants
|
7 Participants
n=158 Participants
|
21 Participants
n=3208 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
2 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
3 Participants
n=3208 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
1 Participants
n=3208 Participants
|
|
Primary Cancer Site
Breast
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
1 Participants
n=158 Participants
|
2 Participants
n=3208 Participants
|
|
Primary Cancer Site
Colon
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
4 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
4 Participants
n=3208 Participants
|
|
Primary Cancer Site
Eye and Orbit
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
1 Participants
n=158 Participants
|
1 Participants
n=3208 Participants
|
|
Primary Cancer Site
Lip, Oral Cavity and Pharynx
|
1 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
2 Participants
n=123 Participants
|
1 Participants
n=158 Participants
|
4 Participants
n=3208 Participants
|
|
Primary Cancer Site
Other Digestive Organ
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
1 Participants
n=3208 Participants
|
|
Primary Cancer Site
Other Urinary
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
1 Participants
n=158 Participants
|
1 Participants
n=3208 Participants
|
|
Primary Cancer Site
Ovary
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
1 Participants
n=3208 Participants
|
|
Primary Cancer Site
Pancreas
|
1 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
2 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
3 Participants
n=3208 Participants
|
|
Primary Cancer Site
Soft Tissue
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
1 Participants
n=158 Participants
|
1 Participants
n=3208 Participants
|
|
Primary Cancer Site
Stomach
|
1 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
1 Participants
n=158 Participants
|
2 Participants
n=3208 Participants
|
|
Primary Cancer Site
Unknown Sites
|
2 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
2 Participants
n=123 Participants
|
1 Participants
n=158 Participants
|
5 Participants
n=3208 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: No participants were enrolled in Arm B
Number of Treatment-related Adverse Events
Outcome measures
| Measure |
Arm A: Personalized Vaccine and Anti- PD-1 Administered Concurrently at the Start of Study Therapy.
n=5 Participants
Personalized vaccine and anti- PD-1 administered concurrently at the start of study therapy. Personalized vaccine will be administered by subcutaneous injection. Vaccine will be administered every three weeks for a total of three doses. Vaccine may continue to be administered at 3 week intervals for an additional 9 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit.
Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks.
Pembrolizumab: Pembrolizumab was administered intravenous (IV) infusion every 3 weeks.
|
Arm B: Anti-PD-1 Antibody for 6 Weeks Followed by Personalized Vaccine Therapy.
Anti-PD-1 antibody for 6 weeks followed by personalized vaccine therapy. Personalized vaccine will be administered by subcutaneous injection. Vaccine will be administered every three weeks for a total of three doses. Vaccine may continue to be administered at 3 week intervals for an additional 9 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit.
Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks.
Pembrolizumab: Pembrolizumab was administered intravenous (IV) infusion every 3 weeks.
|
Arm C: Personalized Vaccine & Anti- PD-1 Administered Concurrently in a Boosted Schedule
n=13 Participants
Personalized vaccine and anti- PD-1 administered concurrently in a boosted schedule at the start of study therapy. Personalized vaccine will be administered by intramuscular injection. Vaccine will be administered three weekly priming vaccine doses, followed by six vaccine doses administered every three weeks. Vaccine may continue to be administered at 3 week intervals for an additional 18 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit.
Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks.
Pembrolizumab: Pembrolizumab was administered intravenous (IV) infusion every 3 weeks.
|
Arm D: Personalized Vaccine Alone, in a Boosted Schedule at the Start of Study Therapy.
n=7 Participants
Personalized vaccine alone, in a boosted schedule at the start of study therapy. Personalized vaccine will be administered by intramuscular injection. Vaccine will be administered three weekly priming vaccine doses, followed by six vaccine doses administered every three weeks. Vaccine may continue to be administered at 3 week intervals for an additional 18 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit.
Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks.
|
|---|---|---|---|---|
|
Treatment-related Adverse Events
|
19 Number of Treatment-related Adverse Even
|
—
|
103 Number of Treatment-related Adverse Even
|
85 Number of Treatment-related Adverse Even
|
SECONDARY outcome
Timeframe: 1 yearPopulation: No participants enrolled in Arm B
RECIST 1.1 - Overall Response
Outcome measures
| Measure |
Arm A: Personalized Vaccine and Anti- PD-1 Administered Concurrently at the Start of Study Therapy.
n=5 Participants
Personalized vaccine and anti- PD-1 administered concurrently at the start of study therapy. Personalized vaccine will be administered by subcutaneous injection. Vaccine will be administered every three weeks for a total of three doses. Vaccine may continue to be administered at 3 week intervals for an additional 9 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit.
Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks.
Pembrolizumab: Pembrolizumab was administered intravenous (IV) infusion every 3 weeks.
|
Arm B: Anti-PD-1 Antibody for 6 Weeks Followed by Personalized Vaccine Therapy.
Anti-PD-1 antibody for 6 weeks followed by personalized vaccine therapy. Personalized vaccine will be administered by subcutaneous injection. Vaccine will be administered every three weeks for a total of three doses. Vaccine may continue to be administered at 3 week intervals for an additional 9 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit.
Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks.
Pembrolizumab: Pembrolizumab was administered intravenous (IV) infusion every 3 weeks.
|
Arm C: Personalized Vaccine & Anti- PD-1 Administered Concurrently in a Boosted Schedule
n=13 Participants
Personalized vaccine and anti- PD-1 administered concurrently in a boosted schedule at the start of study therapy. Personalized vaccine will be administered by intramuscular injection. Vaccine will be administered three weekly priming vaccine doses, followed by six vaccine doses administered every three weeks. Vaccine may continue to be administered at 3 week intervals for an additional 18 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit.
Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks.
Pembrolizumab: Pembrolizumab was administered intravenous (IV) infusion every 3 weeks.
|
Arm D: Personalized Vaccine Alone, in a Boosted Schedule at the Start of Study Therapy.
n=7 Participants
Personalized vaccine alone, in a boosted schedule at the start of study therapy. Personalized vaccine will be administered by intramuscular injection. Vaccine will be administered three weekly priming vaccine doses, followed by six vaccine doses administered every three weeks. Vaccine may continue to be administered at 3 week intervals for an additional 18 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit.
Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks.
|
|---|---|---|---|---|
|
Overall Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Arm A: Personalized Vaccine and Anti- PD-1 Administered Concurrently at the Start of Study Therapy.
Serious events: 2 serious events
Other events: 5 other events
Deaths: 5 deaths
Arm B: Anti-PD-1 Antibody for 6 Weeks Followed by Personalized Vaccine Therapy.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm C: Personalized Vaccine & Anti- PD-1 Administered Concurrently in a Boosted Schedule
Serious events: 3 serious events
Other events: 13 other events
Deaths: 9 deaths
Arm D: Personalized Vaccine Alone, in a Boosted Schedule at the Start of Study Therapy.
Serious events: 0 serious events
Other events: 7 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm A: Personalized Vaccine and Anti- PD-1 Administered Concurrently at the Start of Study Therapy.
n=5 participants at risk
Personalized vaccine and anti- PD-1 administered concurrently at the start of study therapy. Personalized vaccine will be administered by subcutaneous injection. Vaccine will be administered every three weeks for a total of three doses. Vaccine may continue to be administered at 3 week intervals for an additional 9 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit.
Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks.
Pembrolizumab: Pembrolizumab was administered intravenous (IV) infusion every 3 weeks.
|
Arm B: Anti-PD-1 Antibody for 6 Weeks Followed by Personalized Vaccine Therapy.
Anti-PD-1 antibody for 6 weeks followed by personalized vaccine therapy. Personalized vaccine will be administered by subcutaneous injection. Vaccine will be administered every three weeks for a total of three doses. Vaccine may continue to be administered at 3 week intervals for an additional 9 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit.
Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks.
Pembrolizumab: Pembrolizumab was administered intravenous (IV) infusion every 3 weeks.
|
Arm C: Personalized Vaccine & Anti- PD-1 Administered Concurrently in a Boosted Schedule
n=13 participants at risk
Personalized vaccine and anti- PD-1 administered concurrently in a boosted schedule at the start of study therapy. Personalized vaccine will be administered by intramuscular injection. Vaccine will be administered three weekly priming vaccine doses, followed by six vaccine doses administered every three weeks. Vaccine may continue to be administered at 3 week intervals for an additional 18 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit.
Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks.
Pembrolizumab: Pembrolizumab was administered intravenous (IV) infusion every 3 weeks.
|
Arm D: Personalized Vaccine Alone, in a Boosted Schedule at the Start of Study Therapy.
n=7 participants at risk
Personalized vaccine alone, in a boosted schedule at the start of study therapy. Personalized vaccine will be administered by intramuscular injection. Vaccine will be administered three weekly priming vaccine doses, followed by six vaccine doses administered every three weeks. Vaccine may continue to be administered at 3 week intervals for an additional 18 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit.
Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/5 • 4 years, 11 months
No participants enrolled in Arm B
|
—
0/0 • 4 years, 11 months
No participants enrolled in Arm B
|
7.7%
1/13 • Number of events 1 • 4 years, 11 months
No participants enrolled in Arm B
|
0.00%
0/7 • 4 years, 11 months
No participants enrolled in Arm B
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal obstruction
|
20.0%
1/5 • Number of events 1 • 4 years, 11 months
No participants enrolled in Arm B
|
—
0/0 • 4 years, 11 months
No participants enrolled in Arm B
|
0.00%
0/13 • 4 years, 11 months
No participants enrolled in Arm B
|
0.00%
0/7 • 4 years, 11 months
No participants enrolled in Arm B
|
|
Infections and infestations
Lung infection
|
20.0%
1/5 • Number of events 2 • 4 years, 11 months
No participants enrolled in Arm B
|
—
0/0 • 4 years, 11 months
No participants enrolled in Arm B
|
0.00%
0/13 • 4 years, 11 months
No participants enrolled in Arm B
|
0.00%
0/7 • 4 years, 11 months
No participants enrolled in Arm B
|
|
Nervous system disorders
Spinal cord compression
|
20.0%
1/5 • Number of events 1 • 4 years, 11 months
No participants enrolled in Arm B
|
—
0/0 • 4 years, 11 months
No participants enrolled in Arm B
|
0.00%
0/13 • 4 years, 11 months
No participants enrolled in Arm B
|
0.00%
0/7 • 4 years, 11 months
No participants enrolled in Arm B
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
1/5 • Number of events 1 • 4 years, 11 months
No participants enrolled in Arm B
|
—
0/0 • 4 years, 11 months
No participants enrolled in Arm B
|
0.00%
0/13 • 4 years, 11 months
No participants enrolled in Arm B
|
0.00%
0/7 • 4 years, 11 months
No participants enrolled in Arm B
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • 4 years, 11 months
No participants enrolled in Arm B
|
—
0/0 • 4 years, 11 months
No participants enrolled in Arm B
|
7.7%
1/13 • Number of events 2 • 4 years, 11 months
No participants enrolled in Arm B
|
0.00%
0/7 • 4 years, 11 months
No participants enrolled in Arm B
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • 4 years, 11 months
No participants enrolled in Arm B
|
—
0/0 • 4 years, 11 months
No participants enrolled in Arm B
|
7.7%
1/13 • Number of events 1 • 4 years, 11 months
No participants enrolled in Arm B
|
0.00%
0/7 • 4 years, 11 months
No participants enrolled in Arm B
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/5 • 4 years, 11 months
No participants enrolled in Arm B
|
—
0/0 • 4 years, 11 months
No participants enrolled in Arm B
|
7.7%
1/13 • Number of events 1 • 4 years, 11 months
No participants enrolled in Arm B
|
0.00%
0/7 • 4 years, 11 months
No participants enrolled in Arm B
|
|
Nervous system disorders
Confusion
|
0.00%
0/5 • 4 years, 11 months
No participants enrolled in Arm B
|
—
0/0 • 4 years, 11 months
No participants enrolled in Arm B
|
7.7%
1/13 • Number of events 1 • 4 years, 11 months
No participants enrolled in Arm B
|
0.00%
0/7 • 4 years, 11 months
No participants enrolled in Arm B
|
|
General disorders
Disease progression
|
0.00%
0/5 • 4 years, 11 months
No participants enrolled in Arm B
|
—
0/0 • 4 years, 11 months
No participants enrolled in Arm B
|
7.7%
1/13 • Number of events 1 • 4 years, 11 months
No participants enrolled in Arm B
|
0.00%
0/7 • 4 years, 11 months
No participants enrolled in Arm B
|
Other adverse events
| Measure |
Arm A: Personalized Vaccine and Anti- PD-1 Administered Concurrently at the Start of Study Therapy.
n=5 participants at risk
Personalized vaccine and anti- PD-1 administered concurrently at the start of study therapy. Personalized vaccine will be administered by subcutaneous injection. Vaccine will be administered every three weeks for a total of three doses. Vaccine may continue to be administered at 3 week intervals for an additional 9 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit.
Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks.
Pembrolizumab: Pembrolizumab was administered intravenous (IV) infusion every 3 weeks.
|
Arm B: Anti-PD-1 Antibody for 6 Weeks Followed by Personalized Vaccine Therapy.
Anti-PD-1 antibody for 6 weeks followed by personalized vaccine therapy. Personalized vaccine will be administered by subcutaneous injection. Vaccine will be administered every three weeks for a total of three doses. Vaccine may continue to be administered at 3 week intervals for an additional 9 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit.
Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks.
Pembrolizumab: Pembrolizumab was administered intravenous (IV) infusion every 3 weeks.
|
Arm C: Personalized Vaccine & Anti- PD-1 Administered Concurrently in a Boosted Schedule
n=13 participants at risk
Personalized vaccine and anti- PD-1 administered concurrently in a boosted schedule at the start of study therapy. Personalized vaccine will be administered by intramuscular injection. Vaccine will be administered three weekly priming vaccine doses, followed by six vaccine doses administered every three weeks. Vaccine may continue to be administered at 3 week intervals for an additional 18 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit.
Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks.
Pembrolizumab: Pembrolizumab was administered intravenous (IV) infusion every 3 weeks.
|
Arm D: Personalized Vaccine Alone, in a Boosted Schedule at the Start of Study Therapy.
n=7 participants at risk
Personalized vaccine alone, in a boosted schedule at the start of study therapy. Personalized vaccine will be administered by intramuscular injection. Vaccine will be administered three weekly priming vaccine doses, followed by six vaccine doses administered every three weeks. Vaccine may continue to be administered at 3 week intervals for an additional 18 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit.
Personalized Vaccine: Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks.
|
|---|---|---|---|---|
|
General disorders
General disorders and administration
|
100.0%
5/5 • Number of events 17 • 4 years, 11 months
No participants enrolled in Arm B
|
—
0/0 • 4 years, 11 months
No participants enrolled in Arm B
|
100.0%
13/13 • Number of events 47 • 4 years, 11 months
No participants enrolled in Arm B
|
100.0%
7/7 • Number of events 65 • 4 years, 11 months
No participants enrolled in Arm B
|
|
Infections and infestations
Infections and infestations
|
60.0%
3/5 • Number of events 7 • 4 years, 11 months
No participants enrolled in Arm B
|
—
0/0 • 4 years, 11 months
No participants enrolled in Arm B
|
15.4%
2/13 • Number of events 2 • 4 years, 11 months
No participants enrolled in Arm B
|
14.3%
1/7 • Number of events 1 • 4 years, 11 months
No participants enrolled in Arm B
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
20.0%
1/5 • Number of events 1 • 4 years, 11 months
No participants enrolled in Arm B
|
—
0/0 • 4 years, 11 months
No participants enrolled in Arm B
|
0.00%
0/13 • 4 years, 11 months
No participants enrolled in Arm B
|
0.00%
0/7 • 4 years, 11 months
No participants enrolled in Arm B
|
|
Cardiac disorders
Cardiac Disorders
|
0.00%
0/5 • 4 years, 11 months
No participants enrolled in Arm B
|
—
0/0 • 4 years, 11 months
No participants enrolled in Arm B
|
7.7%
1/13 • Number of events 1 • 4 years, 11 months
No participants enrolled in Arm B
|
0.00%
0/7 • 4 years, 11 months
No participants enrolled in Arm B
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders
|
0.00%
0/5 • 4 years, 11 months
No participants enrolled in Arm B
|
—
0/0 • 4 years, 11 months
No participants enrolled in Arm B
|
0.00%
0/13 • 4 years, 11 months
No participants enrolled in Arm B
|
28.6%
2/7 • Number of events 2 • 4 years, 11 months
No participants enrolled in Arm B
|
|
Endocrine disorders
Endocrine disorders
|
20.0%
1/5 • Number of events 1 • 4 years, 11 months
No participants enrolled in Arm B
|
—
0/0 • 4 years, 11 months
No participants enrolled in Arm B
|
0.00%
0/13 • 4 years, 11 months
No participants enrolled in Arm B
|
0.00%
0/7 • 4 years, 11 months
No participants enrolled in Arm B
|
|
Eye disorders
Eye disorders
|
20.0%
1/5 • Number of events 1 • 4 years, 11 months
No participants enrolled in Arm B
|
—
0/0 • 4 years, 11 months
No participants enrolled in Arm B
|
7.7%
1/13 • Number of events 1 • 4 years, 11 months
No participants enrolled in Arm B
|
0.00%
0/7 • 4 years, 11 months
No participants enrolled in Arm B
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
80.0%
4/5 • Number of events 11 • 4 years, 11 months
No participants enrolled in Arm B
|
—
0/0 • 4 years, 11 months
No participants enrolled in Arm B
|
69.2%
9/13 • Number of events 30 • 4 years, 11 months
No participants enrolled in Arm B
|
42.9%
3/7 • Number of events 5 • 4 years, 11 months
No participants enrolled in Arm B
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
20.0%
1/5 • Number of events 2 • 4 years, 11 months
No participants enrolled in Arm B
|
—
0/0 • 4 years, 11 months
No participants enrolled in Arm B
|
7.7%
1/13 • Number of events 1 • 4 years, 11 months
No participants enrolled in Arm B
|
14.3%
1/7 • Number of events 1 • 4 years, 11 months
No participants enrolled in Arm B
|
|
Investigations
Investigations
|
20.0%
1/5 • Number of events 2 • 4 years, 11 months
No participants enrolled in Arm B
|
—
0/0 • 4 years, 11 months
No participants enrolled in Arm B
|
30.8%
4/13 • Number of events 6 • 4 years, 11 months
No participants enrolled in Arm B
|
28.6%
2/7 • Number of events 4 • 4 years, 11 months
No participants enrolled in Arm B
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
60.0%
3/5 • Number of events 4 • 4 years, 11 months
No participants enrolled in Arm B
|
—
0/0 • 4 years, 11 months
No participants enrolled in Arm B
|
30.8%
4/13 • Number of events 6 • 4 years, 11 months
No participants enrolled in Arm B
|
0.00%
0/7 • 4 years, 11 months
No participants enrolled in Arm B
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
40.0%
2/5 • Number of events 2 • 4 years, 11 months
No participants enrolled in Arm B
|
—
0/0 • 4 years, 11 months
No participants enrolled in Arm B
|
53.8%
7/13 • Number of events 24 • 4 years, 11 months
No participants enrolled in Arm B
|
57.1%
4/7 • Number of events 9 • 4 years, 11 months
No participants enrolled in Arm B
|
|
Nervous system disorders
Nervous system disorders
|
60.0%
3/5 • Number of events 5 • 4 years, 11 months
No participants enrolled in Arm B
|
—
0/0 • 4 years, 11 months
No participants enrolled in Arm B
|
38.5%
5/13 • Number of events 19 • 4 years, 11 months
No participants enrolled in Arm B
|
71.4%
5/7 • Number of events 10 • 4 years, 11 months
No participants enrolled in Arm B
|
|
Psychiatric disorders
Psychiatric disorders
|
20.0%
1/5 • Number of events 2 • 4 years, 11 months
No participants enrolled in Arm B
|
—
0/0 • 4 years, 11 months
No participants enrolled in Arm B
|
15.4%
2/13 • Number of events 3 • 4 years, 11 months
No participants enrolled in Arm B
|
14.3%
1/7 • Number of events 1 • 4 years, 11 months
No participants enrolled in Arm B
|
|
Renal and urinary disorders
Renal and urinary disorders
|
40.0%
2/5 • Number of events 3 • 4 years, 11 months
No participants enrolled in Arm B
|
—
0/0 • 4 years, 11 months
No participants enrolled in Arm B
|
15.4%
2/13 • Number of events 2 • 4 years, 11 months
No participants enrolled in Arm B
|
0.00%
0/7 • 4 years, 11 months
No participants enrolled in Arm B
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
100.0%
5/5 • Number of events 7 • 4 years, 11 months
No participants enrolled in Arm B
|
—
0/0 • 4 years, 11 months
No participants enrolled in Arm B
|
46.2%
6/13 • Number of events 8 • 4 years, 11 months
No participants enrolled in Arm B
|
42.9%
3/7 • Number of events 3 • 4 years, 11 months
No participants enrolled in Arm B
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
40.0%
2/5 • Number of events 3 • 4 years, 11 months
No participants enrolled in Arm B
|
—
0/0 • 4 years, 11 months
No participants enrolled in Arm B
|
53.8%
7/13 • Number of events 12 • 4 years, 11 months
No participants enrolled in Arm B
|
28.6%
2/7 • Number of events 2 • 4 years, 11 months
No participants enrolled in Arm B
|
|
Vascular disorders
Vascular disorders
|
40.0%
2/5 • Number of events 2 • 4 years, 11 months
No participants enrolled in Arm B
|
—
0/0 • 4 years, 11 months
No participants enrolled in Arm B
|
0.00%
0/13 • 4 years, 11 months
No participants enrolled in Arm B
|
0.00%
0/7 • 4 years, 11 months
No participants enrolled in Arm B
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place