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JOURNAL ONKOLOGIE – STUDIE

SPICE Immunogenicity and Safety of Pneumococcal Vaccination in Patients Treated With Immune Checkpoint Inhibitors

Rekrutierend

NCT-Nummer:
NCT03989050

Studienbeginn:
Januar 2021

Letztes Update:
28.08.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University of Cologne

Collaborator:
-

Studienleiter

Sibylle C Mellinghoff, MD
Principal Investigator
University of Cologne

Kontakt

Sibylle C Mellinghoff, MD
Kontakt:
Phone: +49 221 478
Phone (ext.): 85523
E-Mail: sibylle.mellinghoff@uk-koeln.de
» Kontaktdaten anzeigen

Studienlocations (2 von 2)

Studien-Informationen

Detailed Description:

Physicians will be informed by mail and pocket cards with all necessary information about the study, in particular eligibility criteria. Patients currently receiving Immune Checkpoint Inhibitors will be approached by their treating physicians in case of an already scheduled vaccination against S. pneumonia. If a patient agrees to participate in the study and to sign an informed consent form, basic data on demographics, underlying disease, comorbidities, and irAE will be obtained from the electronic health record and entered into the eCRF.

Pneumococcal antibody titers will be drawn at baseline and after 30 days. We will actively follow-up on study patients for four months after enrolment and screen health records of the enrolled patients after four months to record occurrence of irAE.

A blood sample (9 ml) will be drawn before vaccination. Vaccination will either be performed by the treating physician or by a general practitioner. After 30 days, a second blood sample will be taken during an already planned visit at the (outpatient) clinic. Titer assessment will be performed along STIKO recommendations for immunocompromised patients.

All samples for ELISA and OPA titer determination will be stored frozen at Department I for Internal Medicine and titers will be analyzed in batch at the end of this study. All therapies and diagnostics including vaccinations will be administered solely as part of clinical routine and as recommended by appropriate guidelines (RKI STIKO recommendations).

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Signed informed consent form

- Age ≥18 years

- Receiving pneumococcal vaccination for the first time along STIKO criteria

- Therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agentfor melanoma, NSCLC or other malignancy

Exclusion Criteria:

- Patients unwilling/ineligible for vaccination under current STIKO recommendations

- Previous vaccination with any licensed or experimental pneumococcal vaccine

- Concurrent treatment with anti-CTLA-4 agent

Studien-Rationale

Primary outcome:

1. Pneumococcal antibody kinetics (Time Frame - 1 Month):
Comparison of serotype specific IgG antibody titers before and after pneumococcal vaccination in patients receiving ICI



Secondary outcome:

1. Determination of applicability of current assessment methodology (Time Frame - 1 year):
Correlation of serotype specific IgG antibodies measured by ELISA and those measured by OPA after pneumococcal vaccination in patients receiving ICI

2. Incidence of irAE (Time Frame - 1 year):
Assessment of the incidence of irAE in patients vaccinated during ICI treatment

Studien-Arme

  • Melanoma patients
    Patients receiving therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agent for melanoma
  • Non-small cell lung cancer (NSCLC) patients
    Patients receiving therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agent for NSCLC
  • other malignancy patients
    Patients receiving therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agent for other malignancy

Quelle: ClinicalTrials.gov


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