RecruitingPhase 2NCT05663775

Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)

Prophylactic Oral Mesalamine for the Prevention of Immune-Related Colitis in Patients Treated With Ipilimumab/Nivolumab


Sponsor

AHS Cancer Control Alberta

Enrollment

20 participants

Start Date

Aug 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The study team's principal interest is to address the question, "Will prophylactic treatment with mesalamine reduce the incidence and severity of immune-related diarrhea occurring secondarily to treatment with ipi/nivo?"


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a drug called mesalamine (commonly used for inflammatory bowel disease) can prevent a bowel inflammation side effect called colitis that sometimes occurs when people with advanced melanoma receive a powerful combination immunotherapy (ipilimumab plus nivolumab). **You may be eligible if...** - You are 18 or older - You have been diagnosed with advanced (unresectable Stage III or IV) malignant melanoma - You are scheduled to receive ipilimumab and nivolumab (ipi/nivo) combination immunotherapy - You are in reasonably good health (ECOG 0–2) - If you could become pregnant, you have a negative pregnancy test and agree to use effective contraception **You may NOT be eligible if...** - You cannot give informed consent - You have a health condition that makes the study unsafe or impractical - You are pregnant or breastfeeding - You have known allergies to mesalamine or related compounds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMesalamine

Mesalamine, also known as 5-aminosalicylic acid (5-ASA)


Locations(1)

Cross Cancer Institute

Edmonton, Alberta, Canada

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NCT05663775


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