Clinical trial · Observational
COVICI-SURV: COVID-19 Vaccination Around ICI Start and Survival
COVICI-SURV: COVID-19 Vaccination Around Immune Checkpoint Inhibitor Initiation and Survival in a Nationwide Cohort of Patients With Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| COVID-19 Vaccination | — | UNRESOLVED | — |
| Immune Checkpoint Inhibitors | — | UNRESOLVED | — |
| Survival | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- National ICI initiator cohort
- description
- Adults with cancer initiating immune checkpoint inhibitor therapy in France between 28 December 2020 and 22 March 2023, identified in the SNDS.
Primary outcomes (1)
- measure
- All-cause mortality after ICI initiation
- timeFrame
- From ICI initiation to death or administrative censoring on 31 December 2024
- description
- 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.
Secondary outcomes (2)
- measure
- Cancer-specific mortality and non-COVID-19 mortality
- timeFrame
- From ICI initiation to 31 December 2023 for cause-of-death analyses
- description
- Cancer death and non-COVID-19 death are analysed using cause-specific models and competing-risk sensitivity analyses where appropriate.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- adults aged 18 years or older with a cancer diagnosis initiating anti-PD-1, 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: * solid organ or bone marrow transplantation * HIV infection * analysis-specific exclusions/censoring for mixed or non-mRNA COVID-19 vaccine schedules. * For the post-ICI analysis, patients with any COVID-19 vaccine in the 100 days before ICI initiation are excluded.
References
Publications (0)
Data not yet available