Vedolizumab for Immune Mediated Colitis

• Status: Recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Copenhagen
• Treatments: Infliximab; Prednisolone; Vedolizumab

Criteria

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 prednisolone

• Colitis is defined as: colonoscopy with Mayo grade >0 or histological signs of active ICPI colitis or feces calprotectin >200

• Negative pregnancy test in fertile women

• Age ≥ 18.

Exclusion Criteria:

• • Severe ICPI induced colitis requiring hospitalization and IV corticosteroids

• Any ongoing infectious disease, including GI infections

• Neutropenia (< 2.0 10E9/L) within the last month

• Known allergy towards vedolizumab or Infliximab

• Severe heart failure, NYHA grade 3-4

• Colorectal cancer

• Conditions and/or 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