A Phase 2 interventional study of Vedolizumab 300 MG Injection [Entyvio] and Prednisone (and methylprednisolone) in Immune Checkpoint Inhibitor-Related Colitis, sponsored by Shilpa Grover, MD, MPH. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-04.
Sponsored by Shilpa Grover, MD, MPH · Phase 2, Interventional, and Treatment
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.
The main questions it aims to answer are:
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
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:
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.
127 studies on the registry are indexed under Colitis; 31 are open to participants now.
This study's planned enrollment of 80 is above the median of 66 across 91 interventional studies indexed under Colitis.
Browse Colitis studies →This is the only study on the registry with Shilpa Grover, MD, MPH as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Drug: Vedolizumab 300 MG Injection [Entyvio] · Drug: Prednisone (and methylprednisolone) · Other: Placebo Prednisone Capsules · Drug: Placebo for Sulfamethoxazole-Trimethoprim
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.
Drug: Prednisone (and methylprednisolone) · Drug: Prednisone Taper · Other: Placebo Vedolizumab · Other: Sulfamethoxazole-Trimethoprim
This is a biologic medication to treat colitis
Also known as: Entyvio
Drug page: Prednisone
This is a steroid
This is a tapering dose of prednisone
Placebo for Prednisone
Placebo for Vedolizumab
Antibiotic if on \>21 days of steroids
Placebo for antibiotic (Sulfamethoxazole-Trimethoprim) Antibiotic. Only if on \>21 days of prednisone/placebo
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.
Time frame: 8 weeks
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.
Time frame: 5 weeks
Change in calprotectin
As compared to baseline
Time frame: 0, 2, 5 and 8 weeks
Cumulative steroid exposure
Steroid dose x Duration of treatment
Time frame: 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.
Time frame: 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
Time frame: 5 weeks and 8 weeks
Rate of symptomatic remission
Defined as a reduction in stool frequency to \< 4 bowel movements/day at 1 week
Time frame: 5 weeks and 8 weeks
Hospitalization rate
Due to colitis
Time frame: 8 weeks
Rates of colectomy
Due to colitis
Time frame: 8 weeks
Endoscopic resolution of colitis
Rate of endoscopic resolution of colitis will be determined, if endoscopy is performed at 8 weeks
Time frame: 8 weeks
Best overall cancer response
Time frame: 8 weeks and 12 months
Overall survival
Defined as time from the first day of protocol treatment to death or last contact date.
Time frame: 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
Time frame: 5 weeks
Proportion of participants with an AE
Proportion of participants with an AE through week 8 (±5 days) attributable to ICI colitis treatment
Time frame: 8 weeks
Presence of histologic inflammation
Time frame: 0, 8 weeks
Pattern of histologic inflammation
Categorized as: Active Colitis Pattern, Lymphocytic Pattern, Graft Vs Host Disease Pattern, Mixed Pattern.
Time frame: 0, 8 weeks
Time to resumption of cancer treatment
Time frame: 12 months
Plan to share: Yes — De-identified participant data from the final research dataset that underlie results in a publication will be shared upon request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data can be shared no earlier than 1 year following the date of publication. Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
Access criteria: De-identified participant data from the final research dataset used in the published manuscript may be shared under the terms of a Data Use Agreement. Requests may be directed to sgrover@bwh.harvard.edu The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Studies of the drug tested here: Vedolizumab