Mesalamine for Colitis Prevention During Cancer Treatment
(IMPACT 1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates whether mesalamine, a medication for inflammation, can prevent diarrhea caused by cancer treatments with ipilimumab and nivolumab. The goal is to determine if adding mesalamine reduces the frequency and severity of this side effect. Participants will take mesalamine four times a day alongside their usual cancer treatment. The trial seeks individuals with advanced melanoma, a type of skin cancer, who are already receiving these treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot use certain immunosuppressive medications. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that mesalamine is likely to be safe for humans?
Research has shown that mesalamine is generally safe for people. In previous studies, its side effects were similar to those of a placebo, indicating it didn't cause significantly more issues than a sugar pill. This suggests that most people can use it without problems.
Other studies, particularly those involving children and teens with mild conditions, also support its safety. They found that both low and high doses of mesalamine did not cause serious side effects, reassuring its use in various doses and for younger individuals.
Although this trial remains in an early stage, existing evidence about mesalamine's safety is encouraging. It has been used safely for other conditions, supporting its potential use in preventing colitis during cancer treatment.12345Why do researchers think this study treatment might be promising?
Researchers are excited about using Mesalamine for colitis prevention during cancer treatment because it offers a new way to address an uncomfortable side effect of immunotherapy. Unlike the standard preventive measures, which might involve steroids with significant side effects, Mesalamine is an anti-inflammatory specifically targeting the colon. This targeted action could mean fewer side effects and better tolerance for patients undergoing cancer treatment. By potentially reducing inflammation in a focused manner, Mesalamine could enhance the overall comfort and quality of life for patients receiving powerful immunotherapy drugs like Nivolumab and Ipilimumab.
What evidence suggests that mesalamine might be an effective treatment for colitis prevention during cancer treatment?
Research has shown that mesalamine, a medication often used for inflammatory bowel disease, might help prevent colon inflammation caused by cancer treatments like immunotherapy. In this trial, participants will receive mesalamine alongside standard immunotherapy drugs such as ipilimumab and nivolumab. Studies have found that patients taking mesalamine experienced fewer and less severe episodes of this inflammation. Mesalamine reduces swelling in the gut, which is crucial because this type of inflammation can cause significant discomfort and health issues. Some evidence suggests that using mesalamine proactively can improve the quality of life for patients undergoing these treatments.36789
Are You a Good Fit for This Trial?
Adults with advanced melanoma who can consent to treatment, are not pregnant or breastfeeding, agree to use effective birth control, and have no severe health issues that could interfere with the trial. They must have a certain level of blood cells and organ function.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive prophylactic Mesalamine in combination with Ipilimumab/Nivolumab over 4 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 12, 18, and 24 weeks
What Are the Treatments Tested in This Trial?
Interventions
- Mesalamine
Trial Overview
The trial is testing if mesalamine can prevent or lessen diarrhea caused by ipi/nivo therapy in melanoma patients. It's seeing whether taking mesalamine before starting cancer treatment makes a difference.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive 500mg of Mesalamine QID (four times a day) in combination with standard of care Immunotherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
AHS Cancer Control Alberta
Lead Sponsor
Citations
1.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT05663775/prophylactic-mesalamine-to-prevent-colitis-following-treatment-with-ipilimumab-nivolumab-ipinivoProphylactic Mesalamine to Prevent Colitis Following ...
The study team's principal interest is to address the question, "Will prophylactic treatment with mesalamine reduce the incidence and severity ...
2.
ctv.veeva.com
ctv.veeva.com/study/prophylactic-mesalamine-to-prevent-colitis-following-treatment-with-ipilimumab-nivolumab-ipi-nivoProphylactic Mesalamine to Prevent Colitis Following ...
The study team's principal interest is to address the question, "Will prophylactic treatment with mesalamine reduce the incidence and severity ...
Clinical perspective and treatment of immune-related colitis ...
Prophylactic mesalamine to prevent colitis following treatment with ipilimumab/nivolumab (Ipi/Nivo) ... Final, 10-year outcomes with nivolumab ...
Immune-mediated colitis after immune checkpoint inhibitor ...
Patients treated with ICIs may develop autoimmune inflammation of the colon, associated with morbidity, decreased quality of life (QoL), and mortality.
5.
app.trialscreen.org
app.trialscreen.org/trials/phase-2-immune-related-adverse-event-prophylactic-mesalamine-to-prevent-trial-nct05663775Prophylactic Mesalamine to Prevent Colitis Following ...
Participation in this study may help prevent or reduce the severity of diarrhea and other gastrointestinal side effects associated with immunotherapy treatment.
Mesalamine in the treatment and maintenance of remission ...
Mesalamine has been shown to be safe, with a side-effect profile comparable to that of placebo, in addition to being efficacious in inducing and maintaining ...
NCT02093663 | Safety and Efficacy of MMX Mesalamine/ ...
Study Overview. To assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to ...
MMX mesalamine in ulcerative colitis: Major advantages ...
Clinical trials demonstrated a strong efficacy in inducing and maintaining clinical and endoscopic remission in active mild-to-moderate UC. The efficacy is ...
Safety and efficacy of multimatrix mesalamine in paediatric ...
We evaluated the safety and efficacy of low-dose and high-dose once-daily multimatrix mesalamine in children and adolescents with mild-to-moderate UC or those ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.