Retrospective Study of COVID-19 Vaccines in Patients Undergoing Immunotherapy for Cancer. (NCT05025514) | Clinical Trial Compass
TerminatedNot Applicable
Retrospective Study of COVID-19 Vaccines in Patients Undergoing Immunotherapy for Cancer.
Stopped: end of the COVID outbreak
France125 participantsStarted 2021-10-19
Plain-language summary
The investigators wish to set up a pharmaco-epidemiological cohort within the Hospital Territorial Groups of the Cévennes-Gard Camargue, East-Hérault and Haute-Garonne and West Tarn on a specific population, patients undergoing immunotherapy for cancer, as currently there is no data available under "real life" conditions following anti-COVID vaccination19. The hypothesis is that patients undergoing immunotherapy will not develop more vaccine-related adverse events than those observed in the efficacy and safety validation studies of the BNT162b2 mRNA Covid-19, mRNA-1273 SARS CoV-2, Oxford/AstraZeneca and Ad26COV2.S, JMJ Vaccine or J \& J COVID-19 Vaccine.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient having been vaccinated or eligible for inoculation with one of the available anti-COVID19 vaccines (except live attenuated virus) while they were or are undergoing immunotherapy with anti-PD1, anti-PDL1 or anti-CTLA4 immunotherapy whatever the tumor (solid, liquid) managed within the medical oncology services of the Occitanie region.
* Patients affiliated to or beneficiaries of a health insurance scheme.
* Patients who have received written and oral information about the study and who have no objection to participation.
* Adult patients (≥ 18 years).
Exclusion Criteria:
* Patients who have been vaccinated with a live attenuated vaccine.
* Patients with a contraindication to inclusion (including hypersensitivity to the active substance or to one of the excipients, COVID+ PCR test in the last 3 months).
* Minor patients, pregnant women, parturients, nursing mothers, persons in nursing mothers, persons in emergency situations, persons unable to persons unable to express their consent and persons under persons under court protection, subguardianship or subguardianship may not be included in this research.
* Patients in an exclusion period determined by another study.
* Patients for whom it is impossible to give clear information.
* Patients who have expressed an objection to participating in the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study was terminated before it finished — does that mean there wasn't enough data collected to draw any conclusions about whether COVID-19 vaccines affect how cancer patients tolerate immunotherapy, and how should that uncertainty influence my own decisions?
2Since this was a retrospective study looking at real-world patients already on immunotherapy who received COVID-19 vaccines, is there any published or preliminary data from it that might be relevant to my specific type of cancer and the immunotherapy regimen you're considering for me?
3Given that this study was specifically trying to understand whether COVID-19 vaccination changes how well patients tolerate immunotherapy, what do you currently recommend for my vaccination timing relative to my immunotherapy treatment schedule?
4Are there other completed studies or current evidence you'd rely on instead of this terminated trial to guide decisions about COVID-19 vaccination safety for someone on immunotherapy like me?
5If this trial was trying to detect serious tolerability issues when combining COVID-19 vaccines with immunotherapy, does its early termination leave any open safety questions I should be aware of before starting or continuing my treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Tolerance of immunotherapy following anti-COVID-19 vaccination
Timeframe: 24 hours after the vaccination
2
Tolerance of immunotherapy following anti-COVID-19 vaccination
Timeframe: 48 hours after the vaccination
3
Tolerance of immunotherapy following anti-COVID-19 vaccination
Timeframe: 8 days after the vaccination
4
Tolerance of immunotherapy following anti-COVID-19 vaccination
Timeframe: 24 hours after the following vaccination
5
Tolerance of immunotherapy following anti-COVID-19 vaccination
Timeframe: 48 hours after the following vaccination
6
Tolerance of immunotherapy following anti-COVID-19 vaccination
Timeframe: 8 days after the following vaccination
7
Tolerance of immunotherapy following anti-COVID-19 vaccination
Timeframe: 1 month after the following vaccination