*Deep phenotyping of the gut immune system during Immune Checkpoint Inhibitor therapy* (DEFENCE)
Recruiting
- Conditions
- cancer10027655
- Registration Number
- NL-OMON55053
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
•18 years or older
•Written informed consent
•Evaluable according to iRECIST v1.1
•Indication for treatment with anti-PD-1 ICI or a combination of anti-PD-1 and
anti-CTLA-4 ICI
for locally advanced or metastatic cancer for which no curative local
treatment is available.
• Informed consent to participate in Oncolifes Immunotherapy or POINTING
Exclusion Criteria
•Concomitant, chronic or infectious illness in the past 6 months causing
moderate to severe colitis
•Use of a medication in the past 6 months with a known elevated risk of
developing moderate to severe colitis (such as mycophenolate mofetil)
•Gastrointestinal resection
•Ileostomy or colostomy
•Abdominal radiotherapy in the past 6 months
•Pregnancy
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To define the difference in number of CD8+ T cells in the gut mucosa between<br /><br>pre-treatment biopsies and biopsies at 6-8 weeks after starting ICI therapy<br /><br>between responders and non-responders.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To determine the difference in number of CD8+ T cell subpopulations (naïve,<br /><br>memory, effector/cytotoxic) between pre-treatment biopsies and biopsies at 6-8<br /><br>weeks after starting ICI therapybetween responders and non-responders to ICI<br /><br>therapy.<br /><br><br /><br>To determine differences in CD4+ T cell counts between pre-treatment biopsies<br /><br>and biopsies at 6-8 weeks after starting ICI therapy between responders and<br /><br>non-responders to ICI therapy.<br /><br><br /><br>To determine the difference in CD68+ macrophage to mucosal tissue ratio between<br /><br>pre-treatment biopsies and biopsies at 6-8 weeks after starting ICI therapy<br /><br>between responders and non-responders to ICI therapy.<br /><br><br /><br>. </p><br>