An observational study in Cancer, Immune Checkpoint Inhibitors and COVID-19 Vaccination, sponsored by Groupe Hospitalier Pitie-Salpetriere. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Groupe Hospitalier Pitie-Salpetriere · Observational
COVICI-SURV is a nationwide, retrospective observational cohort study using the French national health data system (SNDS) to evaluate whether COVID-19 vaccination, particularly mRNA vaccination, received within 100 days before or after immune checkpoint inhibitor (ICI) initiation is associated with survival among adults with cancer. The cohort includes 95,015 adults initiating anti-PD-1, anti-PD-L1 or anti-CTLA-4 therapy between 28 December 2020 and 22 March 2023. Pre-ICI vaccination is analysed using inverse probability of treatment weighting, and post-ICI vaccination among patients without COVID-19 vaccination in the preceding 100 days is analysed using a cloning-censoring-weighting target-trial emulation. The primary outcome is all-cause mortality; secondary outcomes include cancer-specific mortality, non-COVID-19 mortality and real-world progression-free survival. Follow-up extends to 31 December 2024 for all-cause mortality and to 31 December 2023 for cause-specific mortality.
"This study evaluates the association between peri-ICI COVID-19 vaccination and survival in a nationwide population of adults with cancer initiating immune checkpoint inhibitor therapy in France. The exposure of interest is receipt of at least one COVID-19 mRNA vaccine dose within a prespecified 100-day window before ICI initiation (pre-ICI analysis) or within 100 days after ICI initiation (post-ICI analysis).
The source population is derived from the SNDS and includes adults aged 18 years or older with a cancer diagnosis who initiated a first ICI administration (anti-PD-1, anti-PD-L1 or anti-CTLA-4) between 28 December 2020, corresponding to first COVID-19 vaccine availability in France, and 22 March 2023. ICI initiation is the index date/time zero. Patients are required to have at least 3 years of observable SNDS history before ICI initiation. Patients with solid organ or bone marrow transplantation or HIV infection are excluded.
Two complementary causal contrasts are prespecified. First, in the pre-ICI window, patients receiving at least one mRNA COVID-19 vaccine dose within 100 days before ICI initiation are compared with patients receiving no COVID-19 vaccine in that window; mixed or only non-mRNA schedules in that window are excluded from the primary pre-ICI analysis. Baseline confounding is addressed using inverse probability of treatment weighting. Second, in the post-ICI window, a target trial is emulated among patients without COVID-19 vaccination in the 100 days before ICI initiation. Eligible patients are cloned into strategies of receiving at least one mRNA COVID-19 vaccine dose within 100 days after ICI initiation versus receiving no COVID-19 vaccine in that window. Protocol-deviation censoring and inverse probability of censoring weights are used to address immortal-time bias, time-dependent vaccination and informative censoring.
The primary endpoint is all-cause mortality. Secondary endpoints include cancer-specific mortality, non-COVID-19 mortality and real-world progression-free survival defined from ICI discontinuation or death. Analyses include time-varying hazard ratios and absolute survival differences at clinically relevant time points, cancer-site subgroup analyses, sensitivity analyses using shorter exposure windows and ICI-continuation definitions, comparisons by vaccine platform, analyses of other adult vaccines as control exposures, documented COVID-19 infection, and positive/negative control outcomes to explore residual confounding."
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's enrollment of 95,015 is above the median of 200 across 2,638 observational studies indexed under Neoplasms.
Browse Neoplasms studies →Groupe Hospitalier Pitie-Salpetriere is the lead sponsor of 66 studies on the registry; 4 are open to participants now.
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Adults with cancer in France who initiated a first immune checkpoint inhibitor administration and are recorded in the SNDS during the study period.
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- adults aged 18 years or older with a cancer diagnosis initiating , anti-PD-L1 or anti-CTLA-4 therapy between 28 December 2020 and 22 March 2023 in the SNDS, with at least 3 years of prior observable SNDS history.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults with cancer initiating immune checkpoint inhibitor therapy in France between 28 December 2020 and 22 March 2023, identified in the SNDS.
All-cause mortality after ICI initiation
Death from any cause in adults with cancer initiating ICI, comparing peri-ICI mRNA COVID-19 vaccination strategies with no COVID-19 vaccination. Time-varying hazard ratios and survival differences are estimated at prespecified time points.
Time frame: From ICI initiation to death or administrative censoring on 31 December 2024
Cancer-specific mortality and non-COVID-19 mortality
Cancer death and non-COVID-19 death are analysed using cause-specific models and competing-risk sensitivity analyses where appropriate.
Time frame: From ICI initiation to 31 December 2023 for cause-of-death analyses
Real-world progression-free survival sensitivity analyses
rwPFS is defined from ICI discontinuation or death. Additional analyses evaluate non-mRNA COVID-19 vaccines, pneumococcal/other adult vaccination, documented COVID-19 infection, COVID-19 hospitalization as positive control, and negative-control outcomes.
Time frame: Up to 31 December 2024 for rwPFS/all-cause analyses
Ran from Dec 2020 to primary completion in Dec 2024, 48 months.
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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Groupe Hospitalier Pitie-Salpetriere