VERIFY: Vedolizumab for the Prevention of Immune Checkpoint Inhibitor Related Diarrhea or Colitis in Patients With Cancer

Launched by UNIVERSITY OF CALGARY · Mar 22, 2024

Keywords

ClinConnect Summary

The VERIFY trial is studying whether a medication called vedolizumab can help prevent diarrhea and colitis (inflammation of the colon) caused by immune checkpoint inhibitors (ICIs) in patients with advanced cancer. This trial is specifically for adults aged 65 to 74 who are diagnosed with unresectable stage III or metastatic stage IV cancer and are about to start standard immunotherapy treatment. Eligible participants will need to sign consent and show a specific risk for developing these side effects from their cancer treatment.

If you join the trial, you will receive either vedolizumab or a placebo (a treatment with no active medication) through an IV, and you’ll need to stick to the study's guidelines. It’s important to know that some conditions, like previous use of vedolizumab or certain gastrointestinal diseases, may prevent you from participating. The trial is currently not recruiting participants, but it aims to find a way to help patients avoid these serious side effects, making cancer treatment easier and more tolerable.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Signed informed consent prior to initiation of any study specific activities or procedures
• • Diagnosed with unresectable advanced stage III or metastatic stage IV malignancy
• • Planned for initiation of SOC immunotherapy and development of prognostic biomarker evidence that predisposes to ICI diarrhea/colitis risk
• • Ability to and willingness to adhere to the randomized treatment interventions (vedolizumab or placebo), administered intravenously
• Exclusion Criteria:
• • Condition(s) for which vedolizumab is contraindicated (e.g., hypersensitivity reaction, known allergic reaction to vedolizumab or its components)
• • Current or prior use of vedolizumab or prior immunotherapy exposure for cancer
• • Presence of inflammatory bowel disease (Crohn's disease, ulcerative colitis), indeterminate colitis, or microscopic colitis
• • Presence of ileostomy, colostomy, or short bowel syndrome
• • Presence of known luminal gastrointestinal metastases at baseline
• • Presence of significant pre-existing autoimmune disease (at investigator's discretion)
• • Presence of severe infection(s) or opportunistic infection(s)
• • Active enteric infection with viral, bacterial, or parasitic pathogens
• • Presence of untreated latent or active tuberculosis, or untreated chronic hepatitis B virus
• • Baseline ECOG status grade ≥3
• • Pregnancy or lactation
• • Treatment with another investigational product within 8 weeks of randomization
• • Requirement for baseline anti-diarrheal treatment(s) (including but not limited to loperamide, diphenoxylate-atropine, octreotide, tincture of opium), anticholinergic drug(s), or opioid-based analgesic(s) used specifically for diarrhea control within 14 days of randomization
• • Any condition or diagnosis, that could in the opinion of the Qualified Investigator or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk