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Trial record 1 of 1 for:    NCT03042793
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Vaccination With PD-L1 Peptide Against Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03042793
Recruitment Status : Completed
First Posted : February 3, 2017
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Lene Meldgaard Knudsen, Herlev Hospital

Brief Summary:

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Vaccination
Vaccine: PD-L1 peptide.
Biological: PD-L1 peptide vaccine
PD-L1 peptide given subcutaneously with Montanide ISA-51




Primary Outcome Measures :
  1. Incidence of toxicity [ Time Frame: 12 months ]
    CTCAE = Common Terminology Criteria for Adverse Events v. 4.0 will be used for registration of toxicity


Secondary Outcome Measures :
  1. Evaluation of immunological responses [ Time Frame: 12 months ]
    Immunological assays will be used to identify immunological responses.


Other Outcome Measures:
  1. Clinical response [ Time Frame: 12 months ]
    Will be described according to standard IMWG-criteria for multiple myeloma.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically verified multiple myeloma
  2. Newly treated with HDT and no signs of relapse
  3. Age ≥18 years
  4. Performance status ≤ 2 (ECOG-scale)
  5. Expected survival > 3 months
  6. Sufficiently regenerated bone marrow function, i.e.

    1. Leucocytes ≥ 1,5 x 109
    2. Granulocytes ≥ 1,0 x 109
    3. Thrombocytes ≥ 20 x 109
  7. Creatinine < 2.5 upper normal limit, i.e. < 300 μmol/l
  8. Sufficient liver function, i.e.

    1. ALAT < 2.5 upper normal limit, i.e. ALAT <112 U/l
    2. Bilirubin < 30 U/l
  9. Women agreement to use contraceptive methods with a failure rate of < 1% per year during the treatment period and for at least 120 days after the last treatment.
  10. For men: agreement to use contraceptive measures and agreement to refrain from donating sperm.

Exclusion Criteria:

  1. Non-secretory myeloma
  2. Other malignancies in the medical history excluding squamous cell carcinoma of the skin and patients cured for another malignant disease with no sign of relapse three years after ended treatment.
  3. Significant medical condition per investigators judgement e.g. severe Asthma/COPD, poorly regulated heart condition, insulin dependent diabetes mellitus.
  4. Acute or chronic viral infection e.g. HIV, hepatitis or tuberculosis
  5. Serious known allergies or earlier anaphylactic reactions.
  6. Known sensibility towards Montanide ISA-51
  7. Any active autoimmune diseases e.g. autoimmune neutropenia, thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis, autoimmune glomerulonephritis, autoimmune adrenal deficiency, autoimmune thyroiditis etc.
  8. Pregnant and breastfeeding women.
  9. Fertile women not using secure contraception with a failure rate less than < 1%
  10. Patients taking immune suppressive medications incl. corticosteroids and methotrexate at the time of enrollment
  11. Psychiatric disorders that per investigator judgment could influence compliance.
  12. Treatment with other experimental drugs
  13. Treatment with other anti-cancer drugs - except bisphosphonates and denosumab
  14. Patients with active uncontrolled hypercalcemia
  15. Patients who have received chemotherapy, immune therapy, radiation therapy within the last 28 days.

Information from the National Library of Medicine

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


Locations
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Denmark
Department of Hematology, Universityhospital Herlev and Gentofte
Herlev, Denmark, 2730
Sponsors and Collaborators
Lene Meldgaard Knudsen
Investigators
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Principal Investigator: Nicolai Jørgensen, MD Center for Cancer Immune Therapy, Universityhospital Herlev and Gentofte
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Responsible Party: Lene Meldgaard Knudsen, MD, DMSc, Head of Department, Department of Haematology, Universityhospital Herlev and Gentofte, Herlev Hospital
ClinicalTrials.gov Identifier: NCT03042793    
Other Study ID Numbers: MY0001
2016-000990-19 ( EudraCT Number )
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lene Meldgaard Knudsen, Herlev Hospital:
myeloma
vaccination
PD-L1
peptide vaccine
cancer vaccine
immunotherapy
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases