Open label Randomized Controlled clinical Trial of vedolizumab versus conventional treatment for Checkpoint Inhibitor induced Colitis

Jakob Benedict Seidelin0 个研究点目标入组 76 人开始时间: 2021年2月2日最近更新: 2022年5月9日

适应症

试验速览

暂无简介。

•?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

•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

发起方

Jakob Benedict Seidelin