Status and phase
Conditions
Treatments
About
The goal of this clinical trial is to assess whether the early introduction of biological treatment with a TNF-alpha inhibitor (infliximab) in addition to corticosteroids for severe ir-colitis/diarrhoea will reduce the time to grade ≤ 1 ir-colitis/diarrhoea compared to corticosteroids alone in patients scheduled for ICI treatment for solid tumors and untreated mCTCAE grade 2-4 diarrhoea or colitis.
The main question it aims to answer is:
• Can an early introduction of biological treatment with a TNF-alpha inhibitor (infliximab) in addition to corticosteroids reduce the time to grade ≤ 1 ir-colitis/diarrhoea compared to corticosteroids alone.
Participants will be randomised 1:1:
Arm A: All patients will receive same dose of methylprednisolone i.v. daily. Arm B: Patients allocated to Arm B will in addition receive infliximab i.v. day 1 or 2.
Study patients are evaluated with blood samples, faecal samples and by sigmoidoscopy. Procedures are performed before randomisation and as part of follow up.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
Untreated mCTCAE grade 2-4 diarrhoea or colitis, or persistent mCTCAE grade 2 diarrhoea after administration of loperamide or equivalent for mCTCAE grade ≤ 2 diarrhoea
No signs of colonic perforation or infection
Age ≥ 18
Understands the nature and purpose of the study and the study procedures and has signed informed consent
Is able to read, understand, and complete questionnaires and daily components of the patient Diary for the study period
Histologically confirmed malignant solid tumours
Treatment with immune checkpoint inhibitors (anti-CTLA-4, anti-PD-1 or anti-PD-L1) within the past 12 weeks. Immune checkpoint inhibitors can be administered as single agents or as combination therapy with anti-CTLA-4 and anti-PD-1
No probability of a concomitant treatment (e.g. laxatives) other than the immune checkpoint inhibitor being the causal drug for the colitis or diarrhoea
Prior treatment with immune checkpoint inhibitors is allowed
Usage of prednisolone ≤ 10 mg daily for non irAE is allowed
Diagnostic work up including screening for viral hepatic infection and QuantiFERON-TB for mycobacterium tuberculosis must be requisitioned but will not need to be reported prior to study enrolment
Women of child bearing potential must have a negative serum (preferred) or urine pregnancy test within 72 hours prior to registration.
Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and after the study treatment:
for at least 6 months after the last study treatment, or depending on the duration antineoplastic treatment
Note: A highly effective method of birth control is defined as a method which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Such methods include:
Exclusion Criteria
Primary purpose
Allocation
Interventional model
Masking
195 participants in 2 patient groups
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Central trial contact
Sören K. Petersen, MD
Data sourced from clinicaltrials.gov
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