immune checkpoint inhibitor induced enterocolitis intestinal inflammation caused by checkpoint inhibitor treatment
Conditions
Interventions
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 18 years of age or olderAble and willing to give informed consentDiagnosis of a solid tumorTreatment with any immune checkpoint inhibitor (ICI; anti-CTLA-4, anti-PD-1, anti-PD-L1, LGA3), as mono- or combination therapy, within six months before the onset of colitis symptoms. Current diagnosis of ICI (entero)colitis or ICI induced toxicity of the upper GI tract characterized by grade = 2 esophagitis, gastritis, diarrhea and/or colitis as per CTCAE v6.0 and endoscopy with histology performed.
Exclusion criteria
Exclusion criteria: There is a concern for active concomitant gastrointestinal infection as confirmed by stool tests, other causes of diarrhea/colitis or as per the treating physician based on clinical presentation.Patients who are not able to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare different treatment regimens# for ICI colitis with regards to: a. proportion of patients reaching corticosteroid-free clinical remission (at t= 12 weeks)* b. proportion of patients experiencing a recurrence of colitis**c. corticosteroid exposure since start of ICI colitis treatment (at t= 12 weeks) # This includes dose and number of SIT cycles and will mainly include infliximab and vedolizumab, but any other SIT may be included according to emerging literature*Defined as resolution of diarrhea or colitis to grade 1 or less per Common Terminology Criteria for Adverse Events (CTCAE) **Defined as recurrence of diarrhea or colitis to grade 2 or more (CTCAE) beyond 28 days after resolution of first ICI colitis period | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess clinical, biochemical, imaging, histological and/or endoscopic predictors of ICI colitis treatment response$ and ICI colitis recurrence**To analyze ICI colitis outcomes between patients treated with different treatment regimens# with regards to:steroid-free remission@corticosteroid exposuretime to response/remissionTo analyze tumor-outcomes between patients treated with different treatment regimens# for ICI colitis with regards to:progression-free survival^ and overall survival&best response and duration of response***resumption of ICI or other oncological treatmentTo assess differences in treatment regimens and outcomes of ICI colitis between several expert centers in EuropeTo investigate predictors for chronicity of ICI colitis (IBD-like pattern)To assess quality of life in ICI (entero)colitis patients treated with SIT^^To assess safety of SIT in patients with (entero)colitis&&To assess outcomes of surgery performed as treatment of ICI (entero)colitisTo assess outcomes of other (non-SIT) treatments applied in patients with an initial steroid-refractory or -dependent ICI colitis.To assess predictors and outcomes of patients with upper gastrointestinal toxicity (esophagitis, gastritis, duodenitis) **Defined as recurrence of diarrhea or colitis to grade 2 or more (CTCAE) beyond 28 days after resolution of first ICI colitis period $ Defined as a decrease in CTCAE grade of at least 1 grade or to at least grade 2 colitis. @ Defined as remission* without treatment with/use of steroids^Defined as the length of time during and after treatment with the checkpoint inhibitor, without worsening of the oncological disease. &Defined as time from ICI colitis diagnosis until death. *** Assessed as a part of standard care at regular intervals according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) ^^Assessed by the EQ-5D-5L&&Assessed by collecting information on SIT adverse events prospec | — |
Countries
Belgium, Denmark, France, Netherlands, United Kingdom
Contacts
Public ContactF.D.M. Schaik
Universitair Medisch Centrum Utrecht
Outcome results
None listed