Vedolizumab for the Prevention of ICI Related Diarrhea or Colitis in Patients With Cancer

NCT06337695 | Recruiting Phase 2 DMC

• 1 other identifier: VERIFY (Pilot)
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

IrAE; Immune-related Adverse Event; Diarrhea; Colitis

Keywords

Immune Related Adverse Event; Immune Related diarrhea/colitis

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 5 years

Secondary Outcomes (9)

• To evaluate feasibility of recruitment

  Up to 5 years

• To evaluate feasibility of recruitment

  Up to 5 years

• To evaluate feasibility of recruitment

  Up to 5 years

• To evaluate feasibility of recruitment

  Up to 5 years

• To evaluate feasibility of adhering to the protocol

  Up to 5 years

Study Arms (2)

Vedolizumab

EXPERIMENTAL

Participants receive 300 mg vedolizumab IV at Baseline (Week 0) Weeks 2, 6, 14, and 22.

Biological: Vedolizumab

Placebo

PLACEBO COMPARATOR

Participants receive 300 mg placebo IV at Baseline (Week 0) Weeks 2, 6, 14, and 22.

Biological: Placebo

Interventions

Vedolizumab BIOLOGICAL

300 mg IV at weeks Baseline (Week 0) Weeks 2, 6, 14, and 22.

Vedolizumab

Placebo BIOLOGICAL

300 mg IV at Baseline (Week 0) Weeks 2, 6, 14, and 22.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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
• 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

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

Study Sites (2)

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 5G2, Canada

RECRUITING

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Diarrhea; Colitis

Interventions

vedolizumab

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Christopher Ma, MD

CONTACT

403-592-5013; christopher.ma@ucalgary.ca

Michelle Kan

CONTACT

michelle.kan@cancercarealberta.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participants and site personnel will be blinded to treatment assignment. Randomization procedures intended at preserving blinding include concealed random allocation sequence generation and blocked randomization. The site research pharmacist will be unblinded to treatment assignment, in order to prepare the vedolizumab or placebo infusion. Masking of the infusion will be conducted by the site pharmacist, so that the patient and other site personnel remain blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blinded, Placebo Controlled Trial, parallel group superiority trial

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 29, 2024
• Study Start: August 13, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)