ClinicalTrials.gg
CompletedNCT03357861IMMUNO-REAUpdated Oct 26, 2021

Cancer Patients Treated With Immunotherapy in Intensive Care Unit

An observational study in Cancer, Critical Illness and Immunotherapy, sponsored by University Hospital, Grenoble. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-26.

Sponsored by University Hospital, Grenoble · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

This work aims to describe the characteristics and methods of management of patients suffering from a solid tumor treated with immunotherapy admitted to intensive care.

Read the detailed description

The place of checkpoint inhibitors (anti-PD-1 and PD-L-1) is currently validated in the management of melanoma and metastatic non-small cell lung cancer. The toxicity profile is specific with adverse effects related to immunity. Some side effects (myocarditis, colitis, interstitial lung disease, etc.) can be severe and patient could be hospitalized in intensive care unit.

The question of immunotherapy's imputability in the acute disease is becoming more frequent.

02

Conditions studied

  • Cancer
  • Critical Illness
  • Immunotherapy

Keywords

  • cancer
  • intensive care unit
  • checkpoint inhibitors
  • adverse event
03

In context

Neoplasms

10,822 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's enrollment of 100 is below the median of 200 across 2,641 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 838 studies on the registry; 208 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Cancer patients treated with anti-CTLA4 and/or anti-PD-1 / anti-PD-L1 or up to 6 months after stopping admitted in ICU

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • > or = 18 years old;
  • with a solid tumor;
  • Treatment with anti-CTLA4 and / or / PDL-1 still in progress or up to 6 months after stopping;
  • Admitted to resuscitation or continuous care in an unprogrammed way, whatever the reason.

Exclusion criteria

Exclusion Criteria:

  • Minors;
  • Pregnant or lactating woman;
  • Admission after surgery of a scheduled surgery or for the security of procedure;
  • Anti-CTLA4 and / or / PDL-1 treatment stopped for more than 6 months;
  • Subject under guardianship or deprivation of liberty;
  • Refusal of consent;
  • No affiliation to a health insurance scheme.
Terms in these criteria, in plain language(1)

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 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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. To evaluate the imputability of immunotherapy in the ICU admission reason for lung cancer patients treated by immunotherapy.

    Description of ICU admission reason (immunotherapy toxicity versus other) for lung cancer patients treated by immunotherapy

    Time frame: At ICU discharge (maximum 30 days)

Secondary outcomes

  1. Description of the immunosuppressive treatments prescribed during the stay in intensive care for the patient's care.

    immunosuppressive treatments in intensive care unit

    Time frame: At ICU discharge (maximum 30 days)

  2. Description of ICU survival

    ICU survival

    Time frame: At ICU discharge (maximum 60 days)

  3. Description of hospital survival

    Hospital survival

    Time frame: At hospital discharge (maximum 60 days)

07

Study locations

2 sites
  • Institut Jules Bordet
    Bruxelles, Belgium
  • UniversityHospitalGrenoble
    Grenoble, 38043, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2018 to primary completion in Aug 2021, 35 months.

Of 1,098 non-industry observational studies under Neoplasms, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 227. This study's 35 months is below that.

Counting every sponsor, half of 1,246 studies reached it within 58 months; a quarter within 24 and three quarters within 210.

Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 17, 2017
First posted
Nov 30, 2017
StartActual
Sep 1, 2018
Primary completionActual
Aug 23, 2021
CompletionActual
Aug 23, 2021
Last update
Oct 26, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03357861
Responsible party
Sponsor
First posted
Nov 30, 2017
Start date
Sep 1, 2018
Primary completion
Aug 23, 2021
Completion
Aug 23, 2021
Last update
Oct 26, 2021

Study contacts

Anne-Claire TOFFART, MD-PhD
principal investigator · UniversityHospital Grenoble

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion