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

NCT07729241 | Completed

• 1 other identifier: CIC2503-26-07
• Study Type: observational
• Target: 95,015
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

COVICI-SURV; COVID-19; mRNA vaccine; immune checkpoint inhibitor; SNDS; IPTW; target trial emulation; cloning-censoring-weighting; cancer mortality

Outcome Measures

Primary Outcomes (1)

• 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.

  From ICI initiation to death or administrative censoring on 31 December 2024

Secondary Outcomes (2)

• Cancer-specific mortality and non-COVID-19 mortality

  From ICI initiation to 31 December 2023 for cause-of-death analyses

• Real-world progression-free survival sensitivity analyses

  Up to 31 December 2024 for rwPFS/all-cause analyses

Study Arms (1)

National ICI initiator cohort

Adults with cancer initiating immune checkpoint inhibitor therapy in France between 28 December 2020 and 22 March 2023, identified in the SNDS.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with cancer in France who initiated a first immune checkpoint inhibitor administration and are recorded in the SNDS during the study period.

You may qualify if:

• \- 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.

You may not qualify if:

• solid organ or bone marrow transplantation
• HIV infection
• For the post-ICI analysis, patients with any COVID-19 vaccine in the 100 days before ICI initiation are excluded.

Sponsors & Collaborators

• Groupe Hospitalier Pitie-Salpetriere: lead
• APHP: collaborator
• Sorbonne University: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Hôpital Pitié Salpêtrière / CIC-2503, Paris

Paris, 75013, France

Location

MeSH Terms

Conditions

Neoplasms; COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Clinical Investigation Center Paris Est

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 27, 2026
• Study Start: December 28, 2020
• Primary Completion: December 31, 2024
• Study Completion: September 10, 2026
• Last Updated: September 11, 2026

Record last verified: 2026-07

Locations

FR (1)