Vedolizumab to prevent ICI-related diarrhea or colitis in cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

VERIFY is a multicenter, randomized, double-blind, placebo-controlled trial evaluating vedolizumab, given as six intravenous doses over 6 months in addition to ongoing immunotherapy, to prevent gut inflammation related to immune checkpoint inhibitors. Eligible participants have high risk for ICI-related diarrhea/colitis evidenced by elevated fecal calprotectin after starting ICI. Primary comparison is vedolizumab versus placebo with a safety and efficacy assessment over 12 months of follow-up. The study aims to determine if gut-targeted therapy can reduce incidence and severity of ICI-associated gastrointestinal adverse events in unresectable stage III or metastatic stage IV melanoma, lung, or renal cancer. Enrollment is in Alberta, Canada, under lead sponsor AHS Cancer Control Alberta.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Signed informed consent prior to initiation of any study specific activities or procedures
2. Adult patient ≥18 years old
3. Diagnosed with unresectable advanced stage III or metastatic stage IV malignant melanoma, lung, or renal cancer
4. 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
5. Ability to and willingness to adhere to the randomized treatment interventions (vedolizumab or placebo), administered intravenously
6. 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.
7. 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.

Exclusion Criteria:

1. Condition(s) for which vedolizumab is contraindicated (e.g., hypersensitivity reaction, known allergic reaction to vedolizumab or its components)
2. Current or prior use of vedolizumab
3. Presence of inflammatory bowel disease (Crohn's disease, ulcerative colitis), indeterminate colitis, segmental colitis associated with diverticulosis or microscopic colitis
4. Presence of ileostomy, colostomy, or short bowel syndrome
5. Presence of known luminal gastrointestinal metastases at baseline
6. Presence of significant pre-existing autoimmune disease (at investigator's discretion)
7. Presence of severe infection(s) or opportunistic infection(s)
8. Active enteric infection with viral, bacterial, or parasitic pathogens
9. 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.
10. Baseline ECOG status grade ≥3
11. Pregnancy or lactation (no exclusion for pregnant partner)
12. Treatment with another investigational product within 8 weeks of randomization
13. 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
14. 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

Where it's running

• Arthur J.E. Child Comprehensive Cancer Centre
  Calgary, Alberta, Canada Recruiting
• Cross Cancer Institute
  Edmonton, Alberta, Canada Not yet recruiting

Study contacts

• Study coordinator: Christopher Ma, MD
• Email: christopher.ma@ucalgary.ca
• Phone: 403-592-5013

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using fecal microbiota transplantation to treat diarrhea and colitis from cancer immunotherapy

  This study tests if a stool transplant can help people with melanoma or kidney cancer who are having severe diarrhea and colitis from their immunotherapy treatment.

  Recruiting University of Aarhus · Aarhus N · NCT06206707

• Mesalamine to prevent colitis from ipilimumab plus nivolumab

  This trial will try giving mesalamine to adults with advanced melanoma who are starting ipilimumab plus nivolumab to see if it lowers the chance and severity of immune-related diarrhea and colitis.

  Recruiting Phase 2 AHS Cancer Control Alberta · Edmonton, Alberta · NCT05663775

• Using fecal microbiota transplantation to treat diarrhea or colitis in cancer patients

  This study is testing whether a treatment using healthy gut bacteria can help cancer patients with diarrhea or colitis caused by their cancer treatment feel better.

  Recruiting Phase 1 M.D. Anderson Cancer Center · Houston, Texas · NCT04038619

• Gut health follow-along with Peachbiotic in adults

  This single-arm study tests whether Peachbiotic taken daily for 12 weeks helps adults with gut symptoms feel better.

  Recruiting Peach Perfect · Las Vegas, Nevada · NCT07927907

• Impact of a climate-resilient WASH package in Karamoja schools

  This study tests a climate-resilient water, sanitation and hygiene package in severely water-insecure primary schools in Karamoja to see if it reduces diarrhea and respiratory infections and improves attendance, especially among girls.

  Recruiting Unicef · Moroto · NCT07823231

• Do home water filters improve health for people with private wells in rural Central Appalachia

  This study tests whether providing point-of-use water filters to households using well or spring water in rural Central Appalachia can reduce acute gastrointestinal illness.

  Recruiting Virginia Polytechnic Institute and State University · Johnson City, Tennessee and 1 other locations · NCT07818902

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.