CancerCOVICI-SURVNCT07729241
COVICI-SURV: COVID-19 Vaccination Around ICI Start and Survival
An observational study of Cancer and Immune Checkpoint Inhibitors, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Immune Checkpoint Inhibitors, COVID-19 Vaccination
- How many people
- 95,015 participants
- Where
- 1 siteFrance
- Study dates
- 28 Dec 2020to 10 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVICI-SURV: COVID-19 Vaccination Around Immune Checkpoint Inhibitor Initiation and Survival in a Nationwide Cohort of Patients With Cancer
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.
Read the detailed description
"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."
- 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
- Medical subject headings
- Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From ICI initiation to death or administrative censoring on 31 December 2024
Secondary outcomes (2)
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.
Measured: 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.
Measured: Up to 31 December 2024 for rwPFS/all-cause analyses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start28 Dec 2020
- Primary completion31 Dec 2024
- Study completion10 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 95,015 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Collaborators
- APHP, Sorbonne University, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Principal investigator, Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729241
- Sponsor's protocol ID
- CIC2503-26-07
- Other IDs
- CIC2503-26-07
- Acronym
- COVICI-SURV
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVICI-SURV: COVID-19 Vaccination Around Immune Checkpoint Inhibitor Initiation and Survival in a Nationwide Cohort of Patients With Cancer
- ClinicalTrials.gov ID
- NCT07729241
- Acronym / sponsor ID
- COVICI-SURV / CIC2503-26-07
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95,015 participants (actual)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Collaborators
- APHP, Sorbonne University, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 10 Sep 2026 (actual)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
"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."
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality after ICI initiation
Time frame: From ICI initiation to death or administrative censoring on 31 December 2024
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.
2 secondary outcomes
Cancer-specific mortality and non-COVID-19 mortality
Time frame: From ICI initiation to 31 December 2023 for cause-of-death analyses
Real-world progression-free survival sensitivity analyses
Time frame: Up to 31 December 2024 for rwPFS/all-cause analyses
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Immune Checkpoint Inhibitors, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality after ICI initiation (time frame: From ICI initiation to death or administrative censoring on 31 December 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.