COVICI-SURV: COVID-19 Vaccination Around ICI Start and Survival

NCT07729241 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 95015

Last updated 2026-07-27

No results posted yet for this study

Summary

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.

Conditions

  • Cancer
  • Immune Checkpoint Inhibitors
  • COVID-19 Vaccination
  • Survival

Sponsors & Collaborators

  • APHP

    collaborator OTHER
  • Sorbonne University

    collaborator OTHER
  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV
  • Groupe Hospitalier Pitie-Salpetriere

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-28
Primary Completion
2024-12-31
Completion
2026-08-01

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07729241 on ClinicalTrials.gov