VERIFY: Vedolizumab for the Prevention of Immune Checkpoint Inhibitor Related Diarrhea or Colitis in Patients With Cancer

NCT06337695 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: HREBA.CC-23-0271
• Study Type: interventional
• Target: 298
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Cancer; Cancer Metastatic

Keywords

Immune Checkpoint Inhibitors

Outcome Measures

Primary Outcomes (1)

• Hazard Ratio of Patients achieving ICI-related diarrhea and colitis-free survival a 6-months

  ICI-related diarrhea and colitis will be assessed using Common Terminology Criteria for Adverse Events (CTCAE), and a grade ≥2 will be considered an event.

  Start of immunotherapy therapy and for 6 months

Secondary Outcomes (16)

• Proportion of patients with histologically confirmed colitis-free survival at 6 months

  6 months

• Proportion of patients with severe diarrhea or colitis at 6 months

  6 months

• Hazard Ratio of patients with diarrhea or colitis after 6 months

  6-12 months

• Total average dose of checkpoint inhibitor therapy received within 6 and 12 months

  0 to 6 months; and 0 to 12 months

• Proportion of participants who require temporary ICI discontinuation due to immune-related adverse events (irAEs)

  0 to 12 months

Study Arms (2)

Vedolizumab

EXPERIMENTAL

Participants receive 300 mg vedolizumab IV at weeks 0, 3, 6, 14, and 22.

Biological: Vedolizumab

Placebo

PLACEBO COMPARATOR

Participants receive 300 mg placebo IV at weeks 0, 3, 6, 14, and 22.

Biological: Placebo

Interventions

Vedolizumab BIOLOGICAL

300 mg IV at weeks 0, 3, 6, 14, and 22

Vedolizumab

Placebo BIOLOGICAL

300 mg IV at weeks 0, 3, 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
• 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

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 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

Sponsors & Collaborators

• University of Calgary: lead

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Interventions

vedolizumab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Randomized, Double-Blinded, Placebo Controlled Trial

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 29, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 2, 2024

Record last verified: 2023-10