Trial Outcomes & Findings for Ability of a Dendritic Cell Vaccine to Immunize Melanoma or Epithelial Cancer Patients Against Defined Mutated Neoantigens Expressed by the Autologous Cancer (NCT NCT03300843)

Last Updated: 2019-12-13

Results Overview

Response was assessed by the RECIST v1.1. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

up to 6 months

Results posted on

2019-12-13

Participant Flow

Participant milestones

Participant milestones
Measure	Peptide Loaded Dendritic Cell Vaccine Peptide loaded dendritic cell vaccine on days 0, 14, 28, and 42 Peptide loaded dendritic cell vaccine: On days 0, 14 (+/- 5 days), 28 (+/- 5 days), and 42 (+/- 5 days). The vaccine will be administered as both an intravenous (IV) infusion and a subcutaneous (SQ) injection. The total dose will be divided equally between intravenous (IV) and SQ containing 1.0E7 to 8.0E7 cells per cycle depending upon the manufacturing yield.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ability of a Dendritic Cell Vaccine to Immunize Melanoma or Epithelial Cancer Patients Against Defined Mutated Neoantigens Expressed by the Autologous Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peptide Loaded Dendritic Cell Vaccine n=1 Participants Peptide loaded dendritic cell vaccine on days 0, 14, 28, and 42 Peptide loaded dendritic cell vaccine: On days 0, 14 (+/- 5 days), 28 (+/- 5 days), and 42 (+/- 5 days). The vaccine will be administered as both an intravenous (IV) infusion and a subcutaneous (SQ) injection. The total dose will be divided equally between intravenous (IV) and SQ containing 1.0E7 to 8.0E7 cells per cycle depending upon the manufacturing yield.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	62.0 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 6 months

Outcome measures

Outcome measures
Measure	Peptide Loaded Dendritic Cell Vaccine n=1 Participants Peptide loaded dendritic cell vaccine on days 0, 14, 28, and 42 Peptide loaded dendritic cell vaccine: On days 0, 14 (+/- 5 days), 28 (+/- 5 days), and 42 (+/- 5 days). The vaccine will be administered as both an intravenous (IV) infusion and a subcutaneous (SQ) injection. The total dose will be divided equally between intravenous (IV) and SQ containing 1.0E7 to 8.0E7 cells per cycle depending upon the manufacturing yield.
Percentage of Patients Who Had a Clinical Response (Complete Response (CR) + Partial Response (PR)) to Treatment	0 percentage of participants

SECONDARY outcome

Timeframe: Day 0, Day 14 (± 5 d), Day 28 (± 5 d), and Day 42 (± 5 d)

Enzyme-linked immunosorbent assay (ELISA) and enzyme-linked immune absorbent spot (ELISpot) assays assessed reactivity to the mutated peptide compared to the non-mutated peptide. Differences of 2-3 fold in these assays over the baseline measurement are indicative of true biologic differences.

Outcome measures

Outcome measures
Measure	Peptide Loaded Dendritic Cell Vaccine n=1 Participants Peptide loaded dendritic cell vaccine on days 0, 14, 28, and 42 Peptide loaded dendritic cell vaccine: On days 0, 14 (+/- 5 days), 28 (+/- 5 days), and 42 (+/- 5 days). The vaccine will be administered as both an intravenous (IV) infusion and a subcutaneous (SQ) injection. The total dose will be divided equally between intravenous (IV) and SQ containing 1.0E7 to 8.0E7 cells per cycle depending upon the manufacturing yield.
Number of Participants With 2-3 Fold Increase From Baseline in Reactivity to Circulating Antigen-specific T Cells to the Mutated Peptide Compared to the Non-mutated Peptide Mutated peptide Day 0	0 Participants
Number of Participants With 2-3 Fold Increase From Baseline in Reactivity to Circulating Antigen-specific T Cells to the Mutated Peptide Compared to the Non-mutated Peptide Mutated peptide Day 14	0 Participants
Number of Participants With 2-3 Fold Increase From Baseline in Reactivity to Circulating Antigen-specific T Cells to the Mutated Peptide Compared to the Non-mutated Peptide Mutated peptide Day 28	0 Participants
Number of Participants With 2-3 Fold Increase From Baseline in Reactivity to Circulating Antigen-specific T Cells to the Mutated Peptide Compared to the Non-mutated Peptide Mutated peptide Day 42	0 Participants
Number of Participants With 2-3 Fold Increase From Baseline in Reactivity to Circulating Antigen-specific T Cells to the Mutated Peptide Compared to the Non-mutated Peptide Non-Mutated peptide Day 0	0 Participants
Number of Participants With 2-3 Fold Increase From Baseline in Reactivity to Circulating Antigen-specific T Cells to the Mutated Peptide Compared to the Non-mutated Peptide Non-Mutated peptide Day 14	0 Participants
Number of Participants With 2-3 Fold Increase From Baseline in Reactivity to Circulating Antigen-specific T Cells to the Mutated Peptide Compared to the Non-mutated Peptide Non-Mutated peptide Day 28	0 Participants
Number of Participants With 2-3 Fold Increase From Baseline in Reactivity to Circulating Antigen-specific T Cells to the Mutated Peptide Compared to the Non-mutated Peptide Non-Mutated peptide Day 56	0 Participants

SECONDARY outcome

Timeframe: Date treatment consent signed to date off study, approximately 6 months and 11 days

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	Peptide Loaded Dendritic Cell Vaccine n=1 Participants Peptide loaded dendritic cell vaccine on days 0, 14, 28, and 42 Peptide loaded dendritic cell vaccine: On days 0, 14 (+/- 5 days), 28 (+/- 5 days), and 42 (+/- 5 days). The vaccine will be administered as both an intravenous (IV) infusion and a subcutaneous (SQ) injection. The total dose will be divided equally between intravenous (IV) and SQ containing 1.0E7 to 8.0E7 cells per cycle depending upon the manufacturing yield.
Number of Participants With Serious and Non-serious Adverse Events	1 Participants

Adverse Events

Peptide Loaded Dendritic Cell Vaccine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Peptide Loaded Dendritic Cell Vaccine n=1 participants at risk Peptide loaded dendritic cell vaccine on days 0, 14, 28, and 42 Peptide loaded dendritic cell vaccine: On days 0, 14 (+/- 5 days), 28 (+/- 5 days), and 42 (+/- 5 days). The vaccine will be administered as both an intravenous (IV) infusion and a subcutaneous (SQ) injection. The total dose will be divided equally between intravenous (IV) and SQ containing 1.0E7 to 8.0E7 cells per cycle depending upon the manufacturing yield.
Gastrointestinal disorders Nausea	100.0% 1/1 • Number of events 4 • Date treatment consent signed to date off study, approximately 6 months and 11 days.
General disorders Fatigue	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 11 days.
General disorders Injection site reaction	100.0% 1/1 • Number of events 6 • Date treatment consent signed to date off study, approximately 6 months and 11 days.
Nervous system disorders Headache	100.0% 1/1 • Number of events 7 • Date treatment consent signed to date off study, approximately 6 months and 11 days.
Skin and subcutaneous tissue disorders Skin induration	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 11 days.

Additional Information

Dr. Steven A. Rosenberg

National Cancer Institute

Phone: 240-858-3080

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place