Arginase-1 Peptide Vaccine in Patients With Metastatic Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03689192|
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : February 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer Urothelial Carcinoma Malignant Melanoma Ovarian Cancer Colorectal Cancer Breast Cancer Squamous Cell Carcinoma of the Head and Neck Metastatic Cancer||Biological: ARG1-18,19,20||Phase 1|
Arginase-1 (ARG1) is an enzyme that converts the amino acid arginine into urea and ornithine. ARG1 is mainly expressed in hepatocytes but different myeloid cells are also capable of ARG1-expression.
An ARG1-induced arginine depletion suppresses T cell function through the impairment of the T cell receptor (TCR)-complex. A research group from the Center for Cancer Immune Therapy (CCIT) have identified spontaneous T cell reactivity against ARG1 peptides in peripheral blood mononuclear cells of cancer patients and healthy donors. The theoretic background for an ARG1 peptide vaccine is to activate ARG1-specific T cells to infiltrate the tumor microenvironment and eliminate ARG1-expressing immunosuppressive cells. The aim is to treat 10 patients with progressive solid tumors following treatment with standard of care agents. Patients will receive ARG1 vaccinations administered subcutaneously every third week for 45 weeks.
The primary endpoint is to evaluate safety and toxicity. Immune responses will be assessed using blood- and tumor tissue samples and clinical responses are evaluated using RECIST 1.1.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Arginase-1 Peptide Vaccine in Patients With Metastatic Solid Tumors|
|Actual Study Start Date :||December 17, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||June 2021|
Experimental: ARG1-18,19,20 peptide vaccine
One ARG1-vaccine every third week for 45 weeks.
300 ug ARG1-18,19,20 peptide in water mixed with 500ul montanide
- Adverse events evaluated by CTCAE 4.0 [ Time Frame: One year ]Adverse events are graded 1-5 according to the criteria
- Immune responses [ Time Frame: One year ]To evaluate the immunological impact of the ARG1-18,19,20 peptide vaccines using blood samples and tumor biopsies.
- Overall Survival [ Time Frame: One year ]Overall Survival (OS) defined as time from treatment initiation to death, will be described with use of Kaplan Meier curve.
- 4.Progression free survival [ Time Frame: One year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689192
|Contact: Cathrine L. Lorentzen, MD||+45 firstname.lastname@example.org|
|Contact: Inge Marie Svane, Prof., MD||+45 email@example.com|
|Center for Cancer Immune Therapy Dept. of Hematology/oncology||Recruiting|
|Copenhagen, Herlev, Denmark, 2730|
|Contact: Inge Marie Svane, Prof., MD +4538683868 firstname.lastname@example.org|
|Contact: Cathrine Lorentzen, MD +4538683868 email@example.com|