Status:
UNKNOWN
Vedolizumab for Immune Mediated Colitis
Lead Sponsor:
University of Copenhagen
Conditions:
Immune-Mediated Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Background information Immune check point inhibitors (ICPI) have revolutionized the treatment of a growing number of cancer forms resulting in a rapidly increasing number of patients treated with thes...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04797325
Start Date
August 30 2021
End Date
April 1 2025
Last Update
August 17 2022
Active Locations (1)
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1
Herlev University Hospital
Herlev, Denmark, 2730