Vedolizumab for Immune Mediated Colitis (NCT04797325) | Clinical Trial Compass
UnknownPhase 2
Vedolizumab for Immune Mediated Colitis
Denmark82 participantsStarted 2021-08-30
Plain-language summary
This is an open label randomized trial to evaluate the efficacy and treatment duration with vedolizumab to patients with immune mediated colitis. The trial will include 82 patients randomized into two arms, either standard treatment with prednisolone (plus infliximab in severe cases) or vedolizumab treatment up front.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients with solid tumors treated with PD-1, PD-L1 and /or CTLA-4 inhibitors and where IrAE colitis is preventing further treatment with check point inhibitors
* IrAE colitis where the oncologist suggests treatment with tablet or IV corticosteroids (prednisolone or equivalent)
* Negative pregnancy test in fertile women
* Age ≥ 18.
Exclusion Criteria:
* Any ongoing infectious disease, including GI infections
* Neutropenia within the last month
* Known allergy towards vedolizumab or Infliximab
* Severe heart failure, NYHA grade 3-4
* Colorectal cancer
* Other IrAEs requiring systemic treatment with either prednisolone (\> 10 mg daily or equivalents) or other immunosuppressive medications within 14 days before 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, creamer suppository, male sterilization, or true abstinence throughout study and for a minimum of 3 months after study drug therapy