Boston, MANCT06841705Now EnrollingIRB Ready

Immune Checkpoint Inhibitor-Related Colitis Clinical Trial in Boston, MA

Access cutting-edge immune checkpoint inhibitor-related colitis treatment through this clinical trial at a research site in Boston. Study-provided care at no cost to qualified participants.

Sponsored by Shilpa Grover, MD, MPH

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Expert Care in Boston

Access immune checkpoint inhibitor-related colitis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related immune checkpoint inhibitor-related colitis treatment provided free

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Check if you qualify for this immune checkpoint inhibitor-related colitis clinical trial in Boston, MA

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Why Participate?

  • No-Cost Study Care

  • Local to Boston

    Convenient for MA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Boston site if eligible
  4. 4Begin participation

About This Immune Checkpoint Inhibitor-Related Colitis Study in Boston

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: * 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

Sponsor: Shilpa Grover, MD, MPH

Who Can Participate

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT06841705) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Immune Checkpoint Inhibitor-Related Colitis Treatment Options in Boston, MA

If you're searching for immune checkpoint inhibitor-related colitis treatment options in Boston, MA, this clinical trial (NCT06841705) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced immune checkpoint inhibitor-related colitis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all immune checkpoint inhibitor-related colitis clinical trials near you to find additional studies recruiting in your area.

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