Immune Checkpoint Inhibitor-Related ColitisPhase 2EVITANCT06841705

Early Vedolizumab as First-Line for Immune-Related Colitis Therapy Trial

A Phase 2 study testing Vedolizumab 300 MG Injection [Entyvio], Prednisone (and methylprednisolone) and Prednisone Taper in people with Immune Checkpoint Inhibitor-Related Colitis, run by Shilpa Grover, MD, MPH at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

The goal of this clinical trial is to compare the effectiveness and safety of Vedolizumab with a short course of steroids compared to standard course of steroids for the treatment of immune checkpoint inhibitor colitis (ICI colitis) in adults. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Immune Checkpoint Inhibitor-Related Colitis
What is being tested?: Vedolizumab 300 MG Injection [Entyvio], Prednisone (and methylprednisolone) and Prednisone Taper
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 2 sitesUnited States
Study dates: 15 Jul 2025to 31 Dec 2026
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 19Show fewer

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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Shilpa Grover, MD, MPH contact

6177326389

sgrover@bwh.harvard.edu

Seonyoung Goo contact

sgoo@bwh.harvard.edu

United States2 sites, 2 recruiting

Brigham and Women's Hospital
Boston, Massachusetts, 02115
Shilpa Grover, MD, MPH, 617-632-6389, sgrover@bwh.harvard.edu
Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Elad Sharon, elad_sharon@dfci.harvard.edu
Recruiting

Other trials in United States

About this study

Official title: Early Concomitant Vedolizumab as First-Line for Immune-Related Colitis Therapy Trial

The main questions it aims to answer are:

How many patients treated with Vedolizumab and a short course of steroids experience resolution of colitis at 8 weeks.
How many patients treated with a standard course of steroids experience resolution of colitis at 8 weeks.

Participants will:

Recieve 3 doses of Vedolizumab or a placebo (a look-alike substance that contains no drug) infusions over 6 weeks Receive intravenous Medrol daily for 3 days Receive Prednisone daily for 7 days Receive Prednisone or placebo taper daily Receive Sulfamethoxazole-Trimethoprim or placebo taper daily Weekly checkups and periodic tests

Read the detailed description

This is a phase II, randomized trial to evaluate the efficacy and safety of the drugs Vedolizumab, methylprednisolone, and prednisone to manage the side of effect of colitis caused by immune checkpoint inhibitors (ICIs).

The names of the treatments involved in this study are:

Vedolizumab
Methylprednisolone
Prednisone
Sulfamethoxazole-Trimethoprim

The FDA has approved Vedolizumab, methylprednisolone, and prednisone to treat many conditions affecting the immune system, including colitis.

Participants who enroll in this study will undergo one or more flexible sigmoidoscopies or colonoscopies as part of their clinical care. The first of these procedures would occur at the time of study enrollment, and the second may occur after several weeks of treatment at the discretion of the study doctor. During these procedures, biopsies will be collected for clinical purposes as well as for research purposes. Blood and stool samples will also be collected for research. Any extra samples for research would only be collected only if it is safe for the participant.

Participants will complete weekly follow-ups either over the phone or in-person. During these visits, participants will be asked about any new symptoms or changes in their health, their medications, and their symptoms. Blood for research may be collected at four of these visits if it coincides with a scheduled clinical blood draw.

Participants are expected to be on study treatment for 8 weeks. The study team will review their medical records at 12 months for any changes in their health.

It is expected that approximately 80 people will participate in this research study.

Conditions: Immune Checkpoint Inhibitor-Related Colitis
Being tested: Vedolizumab 300 MG Injection [Entyvio], Prednisone (and methylprednisolone), Prednisone Taper, Placebo Prednisone Capsules, Placebo Vedolizumab
Keywords: Immunotherapy Colitis, Immune Checkpoint Inhibitor Colitis, ICI Colitis, Colitis
Medical subject headings: Colitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vedolizumab 300 MG Injection [Entyvio]Drug
Also called Entyvio
This is a biologic medication to treat colitis
Prednisone (and methylprednisolone)Drug
This is a steroid
Prednisone TaperDrug
This is a tapering dose of prednisone
Placebo Prednisone CapsulesOther
Placebo for Prednisone
Placebo VedolizumabOther
Placebo for Vedolizumab
Sulfamethoxazole-TrimethoprimOther
Antibiotic if on >21 days of steroids
Placebo for Sulfamethoxazole-TrimethoprimDrug
Placebo for antibiotic (Sulfamethoxazole-Trimethoprim) Antibiotic. Only if on >21 days of prednisone/placebo

Study groups in NCT06841705
Study group	Role	What they receive
Vedolizumab and Short Course of Steroids	Experimental	Participants in this arm will receive Vedolizumab infusions (3 doses) and steroids for 10 days (intravenous Medrol daily for 3 days and Prednisone daily for 7 days). Participants may also receive daily placebo (for Prednisone and Sulfamethoxazole-Trimethoprim). Receives: Drug: Vedolizumab 300 MG Injection [Entyvio]; Drug: Prednisone (and methylprednisolone); Other: Placebo Prednisone Capsules; Drug: Placebo for Sulfamethoxazole-Trimethoprim
Standard Course of Steroids	Active comparator	Participants in this arm will receive steroids for 10 days (intravenous Medrol daily for 3 days and Prednisone daily for 7 days), followed by a steroid (Prednisone) taper. Participants may also receive Sulfamethoxazole-Trimethoprim (an antibiotic). Participants will receive 3 placebo infusions. Receives: Drug: Prednisone (and methylprednisolone); Drug: Prednisone Taper; Other: Placebo Vedolizumab; Other: Sulfamethoxazole-Trimethoprim

What is being measured

The primary outcome is the main question the study is designed to answer.

Steroid-free remission rate
Defined as less than 10 mg of prednisone/day and grade 1 or lower diarrhea symptoms without the use of additional biologic rescue medication.
Measured: 8 weeks

Secondary outcomes (15)

Steroid-free remission rate
Defined as less than 10 mg of prednisone/day and grade 1 or lower diarrhea symptoms without the use of additional biologic rescue medication.
Measured: 5 weeks
Change in calprotectin
As compared to baseline
Measured: 0, 2, 5 and 8 weeks
Cumulative steroid exposure
Steroid dose x Duration of treatment
Measured: 5 weeks and 8 weeks
Time to steroid-free colitis remission
Defined as the time from the first day of treatment to the first day with less than 10 mg of prednisone/day and grade 1 or lower symptoms.
Measured: Up to 12 months
Rate of secondary immunosuppression for management of ICI colitis
Defined as the use of open-label prednisone or biologic rescue medication
Measured: 5 weeks and 8 weeks
Rate of symptomatic remission
Defined as a reduction in stool frequency to < 4 bowel movements/day at 1 week
Measured: 5 weeks and 8 weeks
Hospitalization rate
Due to colitis
Measured: 8 weeks
Rates of colectomy
Due to colitis
Measured: 8 weeks
Endoscopic resolution of colitis
Rate of endoscopic resolution of colitis will be determined, if endoscopy is performed at 8 weeks
Measured: 8 weeks
Best overall cancer response
Measured: 8 weeks and 12 months
Overall survival
Defined as time from the first day of protocol treatment to death or last contact date.
Measured: Time of death or 12 months
Proportion of participants with an adverse event (AE)
Proportion of participants with an AE through week 5 (±5 days) attributable to ICI colitis treatment
Measured: 5 weeks
Proportion of participants with an AE
Proportion of participants with an AE through week 8 (±5 days) attributable to ICI colitis treatment
Measured: 8 weeks
Presence of histologic inflammation
Measured: 0, 8 weeks
Pattern of histologic inflammation
Categorized as: Active Colitis Pattern, Lymphocytic Pattern, Graft Vs Host Disease Pattern, Mixed Pattern.
Measured: 0, 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 202531 Dec 2026

First posted24 Feb 2025
Study start15 Jul 2025
Primary completion30 Jul 2026 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Immune Checkpoint Inhibitor-Related ColitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06841705
Sponsor's protocol ID: 24-080
Acronym: EVITA
Status last verified: Nov 2025
First submitted: 11 Feb 2025
Last updated: 4 Nov 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: De-identified participant data from the final research dataset that underlie results in a publication will be shared upon request.