Vaccination With PD-L1 Peptide Against Multiple Myeloma

NCT03042793 | Completed Phase 1 DMC

• 2 other identifiers: MY00012016-000990-19
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

myeloma; vaccination; PD-L1; peptide vaccine; cancer vaccine; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Incidence of toxicity

  CTCAE = Common Terminology Criteria for Adverse Events v. 4.0 will be used for registration of toxicity

  12 months

Secondary Outcomes (1)

• Evaluation of immunological responses

  12 months

Other Outcomes (1)

• Clinical response

  12 months

Study Arms (1)

Vaccination

EXPERIMENTAL

Vaccine: PD-L1 peptide.

Biological: PD-L1 peptide vaccine

Interventions

PD-L1 peptide vaccine BIOLOGICAL

PD-L1 peptide given subcutaneously with Montanide ISA-51

Vaccination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically verified multiple myeloma
• Newly treated with HDT and no signs of relapse
• Age ≥18 years
• Performance status ≤ 2 (ECOG-scale)
• Expected survival \> 3 months
• Sufficiently regenerated bone marrow function, i.e.
• Leucocytes ≥ 1,5 x 109
• Granulocytes ≥ 1,0 x 109
• Thrombocytes ≥ 20 x 109
• Creatinine \< 2.5 upper normal limit, i.e. \< 300 μmol/l
• Sufficient liver function, i.e.
• ALAT \< 2.5 upper normal limit, i.e. ALAT \<112 U/l
• Bilirubin \< 30 U/l
• 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.
• For men: agreement to use contraceptive measures and agreement to refrain from donating sperm.

You may not qualify if:

• Non-secretory myeloma
• 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.
• Significant medical condition per investigators judgement e.g. severe Asthma/COPD, poorly regulated heart condition, insulin dependent diabetes mellitus.
• Acute or chronic viral infection e.g. HIV, hepatitis or tuberculosis
• Serious known allergies or earlier anaphylactic reactions.
• Known sensibility towards Montanide ISA-51
• 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.
• Pregnant and breastfeeding women.
• Fertile women not using secure contraception with a failure rate less than \< 1%
• Patients taking immune suppressive medications incl. corticosteroids and methotrexate at the time of enrollment
• Psychiatric disorders that per investigator judgment could influence compliance.
• Treatment with other experimental drugs
• Treatment with other anti-cancer drugs - except bisphosphonates and denosumab
• Patients with active uncontrolled hypercalcemia
• Patients who have received chemotherapy, immune therapy, radiation therapy within the last 28 days.

Sponsors & Collaborators

• Lene Meldgaard Knudsen: lead

Study Sites (1)

Department of Hematology, Universityhospital Herlev and Gentofte

Herlev, 2730, Denmark

Location

Related Publications (1)

• Jorgensen NG, Klausen U, Grauslund JH, Helleberg C, Aagaard TG, Do TH, Ahmad SM, Olsen LR, Klausen TW, Breinholt MF, Hansen M, Martinenaite E, Met O, Svane IM, Knudsen LM, Andersen MH. Peptide Vaccination Against PD-L1 With IO103 a Novel Immune Modulatory Vaccine in Multiple Myeloma: A Phase I First-in-Human Trial. Front Immunol. 2020 Nov 9;11:595035. doi: 10.3389/fimmu.2020.595035. eCollection 2020.

  PMID: 33240282 DERIVED

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Nicolai Jørgensen, MD

  Center for Cancer Immune Therapy, Universityhospital Herlev and Gentofte

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, DMSc, Head of Department, Department of Haematology, Universityhospital Herlev and Gentofte

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 3, 2017
• Study Start: February 1, 2017
• Primary Completion: May 14, 2020
• Study Completion: May 14, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

DK (1)