MelanomaSPICENCT03989050
Immunogenicity and Safety of Pneumococcal Vaccination in Patients Treated With Immune Checkpoint Inhibitors
An observational study of Melanoma and Non Small Cell Lung Cancer, run by University of Cologne at 2 sites in Germany.
Trial summary
This is a prospective observational study of vaccine efficacy and safety in adult patients with malignancies (melanoma/Hodgkin's lymphoma/Non-small cell lung cancer). The primary objective is to compare serotype specific immunoglobulin G (IgG) antibody titres before and after pneumococcal vaccination in patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Non Small Cell Lung Cancer
- How many people
- 0 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Jan 2022to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients treated with ICI (for melanoma, NSCLC, or other malignancy), vaccinated against S. pneumonia
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Hospital Cologne
Cologne, North Rhine-Westphalia, 50937
HELIOS University Hospital Wuppertal
Wuppertal, North Rhine-Westphalia, 42283
About this study
This is a prospective observational study of vaccine efficacy and safety in adult patients with malignancies (melanoma/Hodgkin's lymphoma/Non-small cell lung cancer). The primary objective is to compare serotype specific immunoglobulin G (IgG) antibody titres before and after pneumococcal vaccination in patients receiving Immune Checkpoint Inhibitors (ICI). As an explorative objective, serotype specific IgG antibodies measured by ELISA and those measured by Opsonophagocytosis assay (OPA) after pneumococcal vaccination in patients receiving ICI will be correlated. In addition, the incidence of immune related adverse events (irAE) in patients vaccinated during ICI treatment will be determined.
Read the 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).
- Conditions
- Melanoma, Non Small Cell Lung Cancer
- Keywords
- Immune Checkpoint Inhibitor, Pneumococcal Vaccination
- Medical subject headings
- Melanoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumococcal antibody kinetics
Comparison of serotype specific IgG antibody titers before and after pneumococcal vaccination in patients receiving ICI
Measured: 1 Month
Secondary outcomes (2)
Determination of applicability of current assessment methodology
Correlation of serotype specific IgG antibodies measured by ELISA and those measured by OPA after pneumococcal vaccination in patients receiving ICI
Measured: 1 year
Incidence of irAE
Assessment of the incidence of irAE in patients vaccinated during ICI treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start1 Jan 2022
- Primary completion1 Jan 2023
- Study completion1 Jun 2024
Why it stopped: Administrative reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibylle C Mellinghoff, University of Cologne
- Investigators
- Sibylle C Mellinghoff, MD, Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03989050
- Sponsor's protocol ID
- SPICE
- Acronym
- SPICE
- Status last verified
- Sep 2024
- First submitted
- 13 Jun 2019
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Pneumococcal Vaccination in Patients Treated With Immune Checkpoint Inhibitors
- ClinicalTrials.gov ID
- NCT03989050
- Acronym / sponsor ID
- SPICE / SPICE
- Conditions
- Melanoma, Non Small Cell Lung Cancer
- Keywords
- Immune Checkpoint Inhibitor, Pneumococcal Vaccination
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Administrative reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 18 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective observational study of vaccine efficacy and safety in adult patients with malignancies (melanoma/Hodgkin's lymphoma/Non-small cell lung cancer). The primary objective is to compare serotype specific immunoglobulin G (IgG) antibody titres before and after pneumococcal vaccination in patients receiving Immune Checkpoint Inhibitors (ICI). As an explorative objective, serotype specific IgG antibodies measured by ELISA and those measured by Opsonophagocytosis assay (OPA) after pneumococcal vaccination in patients receiving ICI will be correlated. In addition, the incidence of immune related adverse events (irAE) in patients vaccinated during ICI treatment will be determined.
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients treated with ICI (for melanoma, NSCLC, or other malignancy), vaccinated against S. pneumonia
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pneumococcal antibody kinetics
Time frame: 1 Month
Comparison of serotype specific IgG antibody titers before and after pneumococcal vaccination in patients receiving ICI
2 secondary outcomes
Determination of applicability of current assessment methodology
Time frame: 1 year
Incidence of irAE
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sibylle C Mellinghoff, MD principal investigator
University of Cologne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma and Non Small Cell Lung Cancer, run by University of Cologne at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pneumococcal antibody kinetics (time frame: 1 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.