Clinical Trial of vedolizumab versus conventional treatment for Checkpoint Inhibitor induced Colitis

Phase 1

• Conditions: Immune check point inhibitor induced colitis; MedDRA version: 22.0Level: LLTClassification code 10082455Term: Immune-mediated colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-005793-10-DK
• Lead Sponsor: Jakob Benedict Seidelin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-02
• Last Update Posted: 9 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

?Patients with solid tumors treated with PD-1, PD-L1 and /or CTLA-4 inhibitors and where ICPI induced colitis is preventing further treatment with check point inhibitors
?ICPI induced colitis where the oncologist suggest treatment with tablet corticosteroids
?Negative pregnancy test in women
?Age = 18.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 41
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 41

Exclusion Criteria

•Any ongoing infectious disease, including GI infections.
•Neutropenia (< 2.0 10E9/L)
•Allergy towards vedolizumab or Infliximab
•Severe heart failure, NYHA grade 3-4
•Colorectal cancer
•Diarrhea without signs of colitis (see definition under inclusion criteria)
•Conditions and/or other irAEs requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration
•Females of childbearing potential or males of reproductive potential who are not willing to use an effective method of contraception, such as oral, injected, or implanted hormonal methods of contraception, intrauterine device or intrauterine system, condom in combination with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam, gel, film, creamor suppository, male sterilization, or true abstinence throughout study and for a minimum of 3 months after study drug therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified