Trial Outcomes & Findings for Arginase-1 Peptide Vaccine in Patients With Metastatic Solid Tumors (NCT NCT03689192)
NCT ID: NCT03689192
Last Updated: 2023-02-28
Results Overview
Patients were evaluated according to Common Terminology Criteria for Adverse Events (CTCEA). An adverse event (AE) is an abnormal clinical finding. Each participant was assessed from start of treatment until 6 months after the last vaccine.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
0 - 75 weeks
Results posted on
2023-02-28
Participant Flow
Participant milestones
| Measure |
ARG1-18,19,20 Peptide Vaccine
One ARG1-vaccine every third week for 45 weeks.
ARG1-18,19,20: 300 ug ARG1-18,19,20 peptide in water mixed with 500ul montanide
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
ARG1-18,19,20 Peptide Vaccine
n=10 Participants
One ARG1-vaccine every third week for 45 weeks.
ARG1-18,19,20: 300 ug ARG1-18,19,20 peptide in water mixed with 500ul montanide
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=10 Participants
|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 8.5 • n=10 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=10 Participants
|
|
Region of Enrollment
Denmark
|
10 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 0 - 75 weeksPatients were evaluated according to Common Terminology Criteria for Adverse Events (CTCEA). An adverse event (AE) is an abnormal clinical finding. Each participant was assessed from start of treatment until 6 months after the last vaccine.
Outcome measures
| Measure |
ARG1-18,19,20 Peptide Vaccine
n=10 Participants
One ARG1-vaccine every third week for 45 weeks.
ARG1-18,19,20: 300 ug ARG1-18,19,20 peptide in water mixed with 500ul montanide
|
|---|---|
|
Adverse Events Evaluated by CTCAE 4.0
patients with worst AE grade 1
|
1 Participants
|
|
Adverse Events Evaluated by CTCAE 4.0
patients with worst AE grade 2
|
7 Participants
|
|
Adverse Events Evaluated by CTCAE 4.0
patients with worst AE grade 3
|
2 Participants
|
|
Adverse Events Evaluated by CTCAE 4.0
patients with worst AE grade 4
|
0 Participants
|
SECONDARY outcome
Timeframe: project blood samples were taken at baseline and every 3 months for a maximum of 1,5 year. Tumor biopsies were taken at baseline and after 3 months if possible.Population: Development of a reactive T cell response against at least one of the ARG1 peptides during treatment using interferon-gamma ELISPOT
To evaluate the immunological impact of the ARG1-18,19,20 peptide vaccines using blood samples and tumor biopsies.
Outcome measures
| Measure |
ARG1-18,19,20 Peptide Vaccine
n=10 Participants
One ARG1-vaccine every third week for 45 weeks.
ARG1-18,19,20: 300 ug ARG1-18,19,20 peptide in water mixed with 500ul montanide
|
|---|---|
|
Immune Responses
|
5 Participants
|
SECONDARY outcome
Timeframe: 0 - 75 weeksOverall Survival (OS) defined as time from treatment initiation to death, will be described with use of Kaplan Meier curve.
Outcome measures
| Measure |
ARG1-18,19,20 Peptide Vaccine
n=10 Participants
One ARG1-vaccine every third week for 45 weeks.
ARG1-18,19,20: 300 ug ARG1-18,19,20 peptide in water mixed with 500ul montanide
|
|---|---|
|
Overall Survival
|
7.3 months
Interval 4.5 to 18.8
|
SECONDARY outcome
Timeframe: 0 - 75 weeksProgression free survival (PFS) defined as the time from treatment initiation to disease progression, relapse or death due to any cause, which ever comes first, will be described with Kaplan Meier curve. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
ARG1-18,19,20 Peptide Vaccine
n=10 Participants
One ARG1-vaccine every third week for 45 weeks.
ARG1-18,19,20: 300 ug ARG1-18,19,20 peptide in water mixed with 500ul montanide
|
|---|---|
|
4.Progression Free Survival
|
62 days
Interval 34.7 to 85.3
|
Adverse Events
ARG1-18,19,20 Peptide Vaccine
Serious events: 3 serious events
Other events: 10 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
ARG1-18,19,20 Peptide Vaccine
n=10 participants at risk
One ARG1-vaccine every third week for 45 weeks.
ARG1-18,19,20: 300 ug ARG1-18,19,20 peptide in water mixed with 500ul montanide
|
|---|---|
|
Gastrointestinal disorders
Ascites
|
10.0%
1/10 • Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal pain
|
10.0%
1/10 • Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)
|
|
Nervous system disorders
Facial paralysis
|
10.0%
1/10 • Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)
|
Other adverse events
| Measure |
ARG1-18,19,20 Peptide Vaccine
n=10 participants at risk
One ARG1-vaccine every third week for 45 weeks.
ARG1-18,19,20: 300 ug ARG1-18,19,20 peptide in water mixed with 500ul montanide
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fatique
|
90.0%
9/10 • Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)
|
|
Gastrointestinal disorders
Nausea
|
40.0%
4/10 • Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pain
|
90.0%
9/10 • Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
2/10 • Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)
|
|
Nervous system disorders
Dizziness
|
30.0%
3/10 • Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)
|
|
Gastrointestinal disorders
Xerostomia
|
10.0%
1/10 • Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)
|
|
Skin and subcutaneous tissue disorders
Granuloma at injection site
|
40.0%
4/10 • Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
3/10 • Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)
|
|
Gastrointestinal disorders
Mucositis
|
10.0%
1/10 • Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
2/10 • Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)
|
|
Infections and infestations
infection
|
10.0%
1/10 • Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
2/10 • Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
1/10 • Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.0%
1/10 • Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)
|
|
Gastrointestinal disorders
Constipation
|
40.0%
4/10 • Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)
|
|
Nervous system disorders
Neuropathy
|
30.0%
3/10 • Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10 • Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)
|
|
Nervous system disorders
Facial paralysis
|
10.0%
1/10 • Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)
|
|
Endocrine disorders
Hypothyroidsm
|
20.0%
2/10 • Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)
|
|
Gastrointestinal disorders
Transaminase elevation
|
70.0%
7/10 • Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)
|
|
Blood and lymphatic system disorders
Anemia
|
30.0%
3/10 • Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)
|
|
Gastrointestinal disorders
Alkaline phosphate increased
|
70.0%
7/10 • Adverse event data were collected at baseline and every 3 weeks (when the vaccine was given) for up to 6 months after the last vaccine ( 6 months follow-up)
|
Additional Information
Cathrine Lund Lorentzen
National Center for Cancer Immune Therapy
Phone: 004538683868
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place