Early vedolizumab as first-line treatment for immune-related colitis
Early Concomitant Vedolizumab as First-Line for Immune-Related Colitis Therapy Trial
We will test whether giving vedolizumab with a short steroid course helps adults with immune checkpoint inhibitor–related colitis recover by 8 weeks better than the usual steroid approach.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Drugs / interventions | Vedolizumab, prednisone |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT06841705 on ClinicalTrials.gov |
What this trial studies
This randomized Phase II trial compares vedolizumab plus a short steroid regimen to the standard steroid course for adults with grade 2–3 immune checkpoint inhibitor–related colitis. Participants receive three vedolizumab or placebo infusions over six weeks, a short course of IV methylprednisolone and oral prednisone with either a prednisone taper or placebo taper, and sulfamethoxazole-trimethoprim or placebo as prophylaxis. Baseline and possible follow-up sigmoidoscopies/colonoscopies with biopsies, plus blood and stool samples, are collected for clinical and research purposes, and participants complete weekly follow-ups. The primary outcome is resolution of colitis at 8 weeks, with safety and steroid exposure as key secondary considerations.
Who should consider this trial
Good fit: Adults (≥18) with endoscopically and histologically confirmed grade 2–3 ICI-related colitis within 8 weeks of immune checkpoint inhibitor therapy who can comply with study procedures and have not recently received biologic immunosuppression are ideal candidates.
Not a fit: Patients with life-threatening or complicated disease such as colonic perforation, abscess, recent bowel obstruction, grade 4 colitis, or those already on recent biologic immunosuppression or chronic high-dose steroids are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could lead to faster colitis resolution with less overall steroid exposure and fewer steroid-related side effects, potentially allowing earlier resumption of cancer therapy.
How similar studies have performed: Retrospective case series and cohort reports suggest vedolizumab can help steroid-refractory ICI colitis, but randomized prospective evidence is limited, so the approach is promising but not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * In order to participate in the study, a patient must meet all the following inclusion criteria: * Age ≥18 years. * Treatment with an ICI for cancer within the past 8 weeks. * Confirmed endoscopic/histologic diagnosis of ICI colitis. * Grade 2-3 diarrhea by Common Terminology Criteria for Adverse Events. * Willing and able to comply with the requirements of the protocol. * Ability to understand and the willingness to sign a written informed consent document. * Exclusion Criteria * Prior history of inflammatory colitis requiring treatment with greater than prednisone 10 mg daily or equivalent or any immunosuppressive medication. * Current or recent use of immunosuppressive biologic medication (for any reason including ICI colitis) within 4 weeks. * Concurrent immune-related adverse event requiring systemic steroids or systemic immunosuppression within 2 weeks. * Colonic perforation or abscess. * Partial or complete bowel obstruction within the last 3 months, signs/symptoms of bowel obstruction, or known radiologic evidence of impending obstruction. * Active Clostridium difficile or other colonic infection. * Concurrent hepatitis B or C infection. * History of untreated tuberculosis and/or positive quantiferon/Tspot test without previous tuberculosis prophylaxis, or untreated active infection with mycobacterium tuberculosis. * Active or known prior infection with nontuberculous mycobacteria (NTM). * Unable or unwilling to undergo a colonoscopy/flexible sigmoidoscopy. * Inpatient status, though patients can be screened while inpatients, they must be outpatient for the planned treatment of ICI colitis. * History of total proctocolectomy. * Female patients who are pregnant or breastfeeding or plan to become pregnant in the next 6 months. * Patients who are unable to give informed consent. * Previous SARS-CoV-2 infection within 10 days for mild infections or 20 days for severe/critical illness prior to first Vedolizumab dose. * Unable to adhere to protocol requirements. * Any condition that the physician investigators deem unsafe, including other conditions or medications that the investigator determines will put the subject at greater risk from vedolizumab plus brief course of steroids. * Allergy to sulfamethoxazole-trimethoprim. * Weight greater than 120 kg.
Where this trial is running
Boston, Massachusetts and 1 other locations
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Shilpa Grover, MD, MPH — Brigham and Women's Hospital
- Study coordinator: Shilpa Grover, MD, MPH
- Email: sgrover@bwh.harvard.edu
- Phone: 6177326389
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.