Mesalamine for Colitis Prevention During Cancer Treatment
(IMPACT 1 Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: AHS Cancer Control Alberta

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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?"

Research Team

Eligibility Criteria

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

My blood counts and kidney, liver functions are within required ranges.

My melanoma is at an advanced stage and cannot be surgically removed.

I am 18 years old or older.

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Exclusion Criteria

I am not on immunosuppressive medication, except for allowed cases.

I have a serious heart condition.

I don't have any severe health issues that could make the study risky for me.

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Treatment Details

Interventions

Mesalamine (Aminosalicylate)

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Prophylactic Mesalamine in combination of Immunotherapy (Nivolumab/Ipilimumab)Experimental Treatment1 Intervention

Participants will receive 500mg of Mesalamine QID (four times a day) in combination with standard of care Immunotherapy