IrAEPhase 2/3NCT06337695
Vedolizumab for the Prevention of ICI Related Diarrhea or Colitis in Patients With Cancer
A Phase 2/3 study testing Vedolizumab in people with IrAE and Immune-related Adverse Event, run by AHS Cancer Control Alberta at 2 sites in Canada.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IrAE, Immune-related Adverse Event, Diarrhea
- What is being tested?
- Vedolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesCanada
- Study dates
- 13 Aug 2026to 1 Dec 2030
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent prior to initiation of any study specific activities or procedures
- Adult patient ≥18 years old
- Diagnosed with unresectable advanced stage III or metastatic stage IV malignant melanoma, lung, or renal cancer
- Planned for initiation of SOC treatment with any immunotherapy and develop an elevated fecal calprotectin > 100 μg/g within 4 weeks of first ICI dose
- Ability to and willingness to adhere to the randomized treatment interventions (vedolizumab or placebo), administered intravenously
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes.
- As per the Health Canada product monograph, WOCBP are strongly recommended to use adequate contraception to prevent pregnancy and to continue its use for at least 6 months after the last study visit.
- Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.
Who cannot join
- 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
- Presence of inflammatory bowel disease (Crohn's disease, ulcerative colitis), indeterminate colitis, segmental colitis associated with diverticulosis 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)
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- 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. If there is a clinical suspicion of either, it is at the discretion of the Investigator to order the appropriate work-up.
- Baseline ECOG status grade ≥3
- Pregnancy or lactation (no exclusion for pregnant partner)
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Michelle Kan contact
Canada2 sites, 2 recruiting
- Recruiting
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
Michelle Kan, michelle.kan@cancercarealberta.ca
- Not yet recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
About this study
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
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
Read the detailed description
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.
- Conditions
- IrAE, Immune-related Adverse Event, Diarrhea, Colitis
- Being tested
- Vedolizumab, Placebo
- Keywords
- Immune Related Adverse Event, Immune Related diarrhea/colitis
- Medical subject headings
- Diarrhea, Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VedolizumabBiological
300 mg IV at weeks Baseline (Week 0) Weeks 2, 6, 14, and 22.
PlaceboBiological
300 mg IV at Baseline (Week 0) Weeks 2, 6, 14, and 22.
| Study group | Role | What they receive |
|---|---|---|
| Vedolizumab | Experimental | Participants receive 300 mg vedolizumab IV at Baseline (Week 0) Weeks 2, 6, 14, and 22. Receives: Biological: Vedolizumab |
| Placebo | Placebo comparator | Participants receive 300 mg placebo IV at Baseline (Week 0) Weeks 2, 6, 14, and 22. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 5 years
Secondary outcomes (9)
To evaluate feasibility of recruitment
- Mean time to site initiation
Measured: Up to 5 years
To evaluate feasibility of recruitment
- Number of screened participants
Measured: Up to 5 years
To evaluate feasibility of recruitment
- Screen failure rate and qualitative assessment of reasons for screen failure
Measured: Up to 5 years
To evaluate feasibility of recruitment
- Qualitative assessment of reasons for screen failure
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start13 Aug 2026
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IrAEStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blinded, Placebo Controlled Trial, parallel group superiority trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337695
- Sponsor's protocol ID
- VERIFY (Pilot)
- Status last verified
- Aug 2026
- First submitted
- 22 Mar 2024
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No