Vaccination With PD-L1 Peptide Against Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT03042793|
Recruitment Status : Completed
First Posted : February 3, 2017
Last Update Posted : July 7, 2020
Title: Vaccination with PD-L1 peptide with Montanide against multiple myeloma after high dose chemotherapy with stem cell support. A phase I first-in-human study.
Hypothesis: In this trial the investigators assess a new immunotherapeutic strategy targeting the immune checkpoint molecule PD-L1 to investigate the potential of vaccination against PD-L1 as a possible anticancer target.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Biological: PD-L1 peptide vaccine||Phase 1|
Background: Multiple myeloma is the second most common hematologic cancer which is despite advances in treatment is still incurable for most patients.
In this trial the investigators assess a new immunotherapeutic strategy targeting the immune checkpoint molecule PD-L1 to investigate the potential of vaccination against PD-L1 as a possible anticancer target.
PD-L1 has been recognized as an important factor in immune regulation and development of immune tolerance in the microenvironment of cancer cells. Cells that express PD-L1 on their surface are known to inhibit the immune system. As seen with the recent advances in immunotherapy against cancer with antibodies against PD-L1, the the immunosuppressive role of the molecule PD-L1 can be antagonized to the benefit of patients with cancer. PD-L1 is expressed on both cancer cells, antigen presenting cells and immunosuppressive cells in the tumor micro-environment. Vaccination against PD-L1 is therefore two sided. The investigators aim to stimulate PD-L1 specific T-cells, hence eliminating both PD-L1 positive tumor cells as well as PD-L1 positive immunosuppressive and antigen presenting cells in the tumor microenvironment. The primary endpoints are safety and toxicity evaluation. Secondary endpoint is immunological response. Clinical response will be described.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vaccination With PD-L1 Peptide With Montanide Against Multiple Myeloma After High Dose Chemotherapy With Stem Cell Support. A Phase I First-in-human Study.|
|Actual Study Start Date :||February 1, 2017|
|Actual Primary Completion Date :||May 14, 2020|
|Actual Study Completion Date :||May 14, 2020|
Vaccine: PD-L1 peptide.
Biological: PD-L1 peptide vaccine
PD-L1 peptide given subcutaneously with Montanide ISA-51
- Incidence of toxicity [ Time Frame: 12 months ]CTCAE = Common Terminology Criteria for Adverse Events v. 4.0 will be used for registration of toxicity
- Evaluation of immunological responses [ Time Frame: 12 months ]Immunological assays will be used to identify immunological responses.
- Clinical response [ Time Frame: 12 months ]Will be described according to standard IMWG-criteria for multiple myeloma.
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): NCT03042793
|Department of Hematology, Universityhospital Herlev and Gentofte|
|Herlev, Denmark, 2730|
|Principal Investigator:||Nicolai Jørgensen, MD||Center for Cancer Immune Therapy, Universityhospital Herlev and Gentofte|