A Phase 1 interventional study of PD-L1 peptide vaccine in Multiple Myeloma, sponsored by Lene Meldgaard Knudsen. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-07.
Sponsored by Lene Meldgaard Knudsen · Phase 1, Interventional, and Treatment
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.
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 10 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Lene Meldgaard Knudsen is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Sufficiently regenerated bone marrow function, i.e.
Sufficient liver function, i.e.
Exclusion Criteria:
Vaccine: PD-L1 peptide.
Biological: PD-L1 peptide vaccine
PD-L1 peptide given subcutaneously with Montanide ISA-51
Incidence of toxicity
CTCAE = Common Terminology Criteria for Adverse Events v. 4.0 will be used for registration of toxicity
Time frame: 12 months
Evaluation of immunological responses
Immunological assays will be used to identify immunological responses.
Time frame: 12 months
Clinical response
Will be described according to standard IMWG-criteria for multiple myeloma.
Time frame: 12 months
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Lene Meldgaard Knudsen