Identification of Predictive Parameters for Colitis in Melanoma Patients Treated With Immunotherapy.

Melanoma Clinical Trial

— COLIPI  

Official title:

Identification of Predictive Parameters for Colitis in Melanoma Patients Treated With Immunotherapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02600143
• Other study ID #: METc 2012/085
• Status: Completed
• Start date: August 2013
• Est. completion date: April 2019

Study information

• Verified date: May 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this trial is to identify biomarkers and genetic predisposition for the development of immune checkpoint related colitis.

Description:

Immunotherapy with immune checkpoint-inhibitors is standard treatment for patients with melanoma. However, in about 15% of patients treated with Ipilimumab a grade 3-4 colitis will occur. In programmed cell death protein 1 (PD1) inhibitors colitis is also seen as adverse event, although less prominent. We want to find a good predictive biomarker to select patients that are prone to colitis.So far no test is available that might be predictive whether a patient will develop a grade 3-4 colitis.

The study will consists of four parts: 1.) to identify a genetic profile associated with ipilimumab-induced colitis, 2.) to identify predictive (serum or fecal) biomarkers for ipilimumab-induced colitis, 3.) to study the tissue of ipilimumab-induced colitis and 4) to study the role of the gut microbiome in the development of colitis. Patients are able to participate in one, or more parts of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with melanoma who will be treated with immune checkpoint inhibitors (ipilimumab, nivolumab, pembrolizumab)

2. Signed written informed consent.

3. Able to comply with the protocol.

Exclusion Criteria:

1. Patients with a pre-existing colitis (e.g. Crohn's disease, ulcerative colitis).

Related Conditions & MeSH terms

• Colitis
• Melanoma

Locations

Country	Name	City	State
Netherlands	UMCG	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic predisposition for immunotherapy-induced colitis	Difference in genetic profile on 99 confirmed inflammatory bowel disease (IBD) loci between patients who develop immunotherapy-induced colitis and who do not.	1 week
Secondary	Predictive biomarkers for immunotherapy-induced colitis in stool and serum	Comparison of calprotectin levels in the stool and serum-levels of C reactive protein (CRP), endotoxin, citrulline, intestinal fatty acid-binding protein (I-FABP), calprotectin and interleukin 8 (IL8) between patients who develop immunotherapy-induced colitis and who do not.	Day 0, 21, 42, 63
Secondary	Clinical scoring system of colitis	Prediction of (severity of) colitis based on symptomatology measured with the MAYO score and BRISTOL stool scale.	Day -7 to 85
Secondary	Histological assessment of colon biopsies in patients that develop colitis	Immunotherapy-induced colitis will be assessed in colon biopsies when a sigmoidoscopy has to be performed for diagnostic reasons.	1 day
Secondary	Analysis of the gut microbiome in stool samples	Microbiome analysis in stool collected before treatment and at 3, 6, and 9 weeks and correlation with development of immunotherapy-induced colitis.	Day 0, 21, 42, 63