VERIFY: Vedolizumab for the Prevention of Immune Checkpoint Inhibitor Related Diarrhea or Colitis in Patients With Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vedolizumab, Placebo.
- Who it may be relevant to
- Registry conditions: Cancer, Cancer Metastatic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
VERIFY: Vedolizumab for the Prevention of Immune Checkpoint Inhibitor Related Diarrhea or Colitis in Patients With Cancer: A Randomized, Double-Blinded, Placebo Controlled Trial
Overview
The purpose of this study is to assess the prevention of immune checkpoint inhibitors (ICIs) related diarrhea/colitis using vedolizumab in participants with unresectable stage III or metastatic stage IV cancer, starting standard of care (SOC) immunotherapy
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo up to a 2-week screening period to confirm their eligibility. Eligible patients will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Vedolizumab or placebo and given their first dose within 2 weeks of starting their SOC immunotherapy. Vedolizumab or placebo will be administered at Weeks 0, 2, 6, 14, and 22.
Interventions
- Biological Vedolizumab
300 mg IV at weeks 0, 3, 6, 14, and 22 - Biological Placebo
300 mg IV at weeks 0, 3, 6, 14, and 22
Primary outcome measures
- Hazard Ratio of Patients achieving ICI-related diarrhea and colitis-free survival a 6-months [Time frame: Start of immunotherapy therapy and for 6 months]
Secondary outcome measures (12)
- Proportion of patients with histologically confirmed colitis-free survival at 6 months [Time frame: 6 months]
- Proportion of patients with severe diarrhea or colitis at 6 months [Time frame: 6 months]
- Hazard Ratio of patients with diarrhea or colitis after 6 months [Time frame: 6-12 months]
- Total average dose of checkpoint inhibitor therapy received within 6 and 12 months [Time frame: 0 to 6 months; and 0 to 12 months]
- Proportion of participants who require temporary ICI discontinuation due to immune-related adverse events (irAEs) [Time frame: 0 to 12 months]
- Proportion of participants who require permanent ICI discontinuation due to irAEs [Time frame: 0 to 12 months]
- Proportion of patients requiring rescue corticosteroids for ICI related diarrhea/colitis [Time frame: at 6-months and 12-months]
- Total average prednisone equivalent dose of rescue corticosteroids required [Time frame: at 6-months and 12-months]
- Proportion of participants requiring all-cause hospitalization by Day +180 and Day +365 [Time frame: at day 180 and 365]
- Proportion of participants requiring ICI-related diarrhea/colitis-specific hospitalization by Day +180 and Day +365 [Time frame: at day 180; at day 365]
- Mean change in the EuroQol EQ-5D instrument at Day +180 and Day +365 compared to baseline [Time frame: baseline to day 180; baseline to day 365]
- Overall survival (measured as death) at +180 and Day +365 compared to baseline [Time frame: Day +180 and Day +365]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06337695 · HREBA.CC-23-0271