Vedolizumab for the Prevention of ICI Related Diarrhea or Colitis in Patients With Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAHS Cancer Control Alberta
About this 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Vedolizumab
Biological/Vaccine300 mg IV at weeks Baseline (Week 0) Weeks 2, 6, 14, and 22.
Placebo
Biological/Vaccine300 mg IV at Baseline (Week 0) Weeks 2, 6, 14, and 22.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: VedolizumabExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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
Time frame
Up to 5 yearsSecondary outcomes
1
To evaluate feasibility of recruitment
• Mean time to site initiation
Time frame
Up to 5 years2
To evaluate feasibility of recruitment
• Number of screened participants
Time frame
Up to 5 years3
To evaluate feasibility of recruitment
• Screen failure rate and qualitative assessment of reasons for screen failure
Time frame
Up to 5 years4
To evaluate feasibility of recruitment
• Qualitative assessment of reasons for screen failure
Time frame
Up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov