Decoding predictors of Colitis induced by Immune checkpoint blockade therapy

Recruiting

Conditions: Immune-checkpoint inhibitor induced colitis
10017969
10027655

Registration Number: NL-OMON53776

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

- Patients fom 18 years diagnosed with a malignancy
- Indication for systemic ICI-treatment with nivolumab or pembrolizumab
(anti-PD-1), atezolizumab, ipilimumab (anti-CTLA-4) monotherapy or the
combination of nivolumab with ipilimumab.
- WHO performance score 0-2

Exclusion Criteria

- Patients, who are not able to provide informed consent.
- History of IBD
- Life expectancy < 6 months
- Viral or bacterial infection within the past week
- Recent use of antibiotics (<3 months)
- Use of anti-inflammatory drugs (for example prednisolone, anti-TNF, anti
IL12/23)
- Patients who are undergoing chemotherapy treatment

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Incidence of any grade and grade 3/4 IMC within 12 weeks.<br /><br>2. Development of grade 3 or 4 IMC with corresponding interval (start immune<br /><br>checkpoint inhibition until symptom onset).<br /><br>3. Frequencies and phenotype of immune cell populations and cytokine production<br /><br>in the colon of patients prior to and during ICI treatment.<br /><br>4. Differences in immune cell populations and cytokine production prior to and<br /><br>during ICI treatment, in patients who eventually develop grade 3 or 4 IMC as<br /><br>compared to those who do not develop IMC.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>5. Differences in the microbiome and metabolome prior to and during ICI<br /><br>treatment, in patients who eventually develop IMC as compared to those who do<br /><br>not develop IMC<br /><br>6. Differences in circulating immune cell populations and cytokines prior to<br /><br>and during ICI treatment, in patients that eventually develop IMC as compared<br /><br>to those who do not develop IMC.<br /><br>7. Differences in immune cell populations, cytokine production, microbiome and<br /><br>metabolome composition in patients undergoing different types of ICI-treatment<br /><br>(anti-PD-1/ anti-CTLA-4).<br /><br>8. Transcriptome of intestinal tissue prior to and during ICI treatment</p><br>