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Arginase-1 Peptide Vaccine in Patients With Metastatic Solid Tumors
Phase 1 trial testing ARG1-18,19,20 in Non Small Cell Lung Cancer in 13 participants. Completed in 19 January 2022.
| Lead sponsor | Herlev Hospital |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 17 December 2018 |
| Primary completion | 19 January 2022 |
| Estimated completion | 19 January 2022 |
| Sites | 1 location across Denmark |
Herlev Hospital
18 and older, any sex, with Non Small Cell Lung Cancer or Urothelial Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| ARG1-18,19,20 Peptide Vaccine | 1 | |
| ARG1-18,19,20 Peptide Vaccine | 7 | |
| ARG1-18,19,20 Peptide Vaccine | 2 | |
| ARG1-18,19,20 Peptide Vaccine | 0 |
To evaluate the immunological impact of the ARG1-18,19,20 peptide vaccines using blood samples and tumor biopsies.
| Group | Value | 95% CI |
|---|---|---|
| ARG1-18,19,20 Peptide Vaccine | 5 |
Overall Survival (OS) defined as time from treatment initiation to death, will be described with use of Kaplan Meier curve.
| Group | Value | 95% CI |
|---|---|---|
| ARG1-18,19,20 Peptide Vaccine | 7.3 | 4.5 – 18.8 |
Progression 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.
| Group | Value | 95% CI |
|---|---|---|
| ARG1-18,19,20 Peptide Vaccine | 62 | 34.7 – 85.3 |
Time frame: 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). Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | ARG1-18,19,20 Peptide Vacc… |
|---|---|---|
| Ascites | Gastrointestinal disorders | — |
| Abdominal pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Facial paralysis | Nervous system disorders | — |
| Reaction | System | ARG1-18,19,20 Peptide Vacc… |
|---|---|---|
| Fatique | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Transaminase elevation | Gastrointestinal disorders | — |
| Alkaline phosphate increased | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Granuloma at injection site | Skin and subcutaneous tissue disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Dizziness | Nervous system disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Neuropathy | Nervous system disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Rash | Skin and subcutaneous tissue disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Hypothyroidsm | Endocrine disorders | — |
| Xerostomia | Gastrointestinal disorders | — |
| Mucositis | Gastrointestinal disorders | — |
| infection | Infections and infestations | — |
| Dry skin | Skin and subcutaneous tissue disorders | — |
| Alopecia | Skin and subcutaneous tissue disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Facial paralysis | Nervous system disorders | — |
Most-reported serious reactions: Ascites, Abdominal pain, Facial paralysis.
Data from ClinicalTrials.gov NCT03689192 adverse events section.
In this phase I first-in-humans-study a vaccine consisting of arginase-1 (ARG1) peptides and the adjuvant Montanide ISA-51 will be tested in ten patients with metastatic solid tumors. Patients will be treated with an ARG1 vaccine every third week for 45 weeks.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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