A Phase 2/3 interventional study of Vedolizumab and Placebo in IrAE, Immune-related Adverse Event and Diarrhea, sponsored by AHS Cancer Control Alberta. Recruiting at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by AHS Cancer Control Alberta · Phase 2/3, Interventional, and Prevention
The purpose of this study is to assess the prevention of immune checkpoint inhibitors (ICI) related diarrhea/colitis using vedolizumab in participants with unresectable stage III or metastatic stage IV cancer, starting standard of care (SOC) immunotherapy
VERIFY is a multicenter, prospective, randomized, double-blinded, placebo-controlled, parallel group superiority trial, evaluating the efficacy and safety of vedolizumab, a monoclonal antibody targeting the α4β7 integrin receptor specific to gut-targeted T-lymphocytes, for the prevention of ICI-related diarrhea and colitis in participants with unresectable melanoma, lung, or renal cancer starting immunotherapy who are at high risk, defined by the development of an elevated fecal calprotectin >100 μg/g within 4 weeks of the first ICI dose.
Eligible participants will be randomized 1:1 to receive 6 months of vedolizumab or placebo, administered as prophylaxis therapy in addition to continuing ICI treatment (administered at weeks 0, 2, 6, 14, and 22). Participants will then be followed for 1 year.
877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.
This study's planned enrollment of 36 is below the median of 137 across 738 interventional studies indexed under Diarrhea.
Browse Diarrhea studies →AHS Cancer Control Alberta is the lead sponsor of 187 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive 300 mg vedolizumab IV at Baseline (Week 0) Weeks 2, 6, 14, and 22.
Biological: Vedolizumab
Participants receive 300 mg placebo IV at Baseline (Week 0) Weeks 2, 6, 14, and 22.
Biological: Placebo
300 mg IV at weeks Baseline (Week 0) Weeks 2, 6, 14, and 22.
300 mg IV at Baseline (Week 0) Weeks 2, 6, 14, and 22.
To establish the feasibility of the VERIFY protocol and determine progression to the full trial
Feasibility defined by achievement of all pre-specified progression criteria: * Recruitment \>75% target (\>0.53 participants per site per month achieving randomization) * Recruitment: fecal calprotectin after first dose of ICI therapy \>100 μg/g in at least 15% of screened participants * Protocol adherence: \>95% of randomized participants receiving allocated treatment, protocol adherence in \>90% * Outcome data quality: endoscopy and biopsies taken in \>90% of eligible participants, \<10% loss to follow-up * Feedback: no major concerns identified by patients or providers on acceptability survey * \>15% of placebo-treated participants developing the primary outcome (sufficient event rate for feasible prevention) * Rate of PFS and OS is not lower than historical estimates from a similar population
Time frame: Up to 5 years
To evaluate feasibility of recruitment
• Mean time to site initiation
Time frame: Up to 5 years
To evaluate feasibility of recruitment
• Number of screened participants
Time frame: Up to 5 years
To evaluate feasibility of recruitment
• Screen failure rate and qualitative assessment of reasons for screen failure
Time frame: Up to 5 years
To evaluate feasibility of recruitment
• Qualitative assessment of reasons for screen failure
Time frame: Up to 5 years
To evaluate feasibility of adhering to the protocol
Adherence feasibility metrics will include: * Proportion of participants receiving the allocated treatment within 2 weeks of randomization * Proportion of participants adhering to the follow-up schedule
Time frame: Up to 5 years
To evaluate feasibility of adhering to the protocol
Adherence feasibility metrics will include: • Number and qualitative description of minor and major protocol deviations
Time frame: Up to 5 years
To evaluate feasibility of obtaining high quality outcome data
Outcome measure feasibility metrics will include: * Proportion of eligible participants undergoing lower endoscopy and biopsies to confirm histologic ICI-related colitis * Proportion of participants lost to follow-up and qualitative assessment of reasons for loss to follow-up
Time frame: Up to 5 years
To evaluate the incidence of diarrhea and colitis in the placebo group
Feasibility of prevention metrics will include: * Proportion of participants receiving placebo who develop CTCAE grade ≥2 diarrhea/colitis * Proportion of participants receiving placebo who develop CTCAE grade ≥3 diarrhea/colitis * Proportion of participants receiving placebo who develop CTCAE any grade diarrhea/colitis
Time frame: Up to 1 year
To evaluate the efficacy of concomitant vedolizumab and ICI therapy
To ensure that there is no interaction between vedolizumab and efficacy of ICI therapy, evaluation will include: • Progression free survival and overall survival in the vedolizumab group (compared to a historical control population)
Time frame: Up to 1 year
Plan to share: No
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Studies of the drug tested here: Vedolizumab