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

Recruiting Phase 2 Interventional Study
Immune-related Adverse Event Diarrhea Advanced Melanoma Advanced Rectal Carcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
20 (estimated)
Sponsor
AHS Cancer Control Alberta · Other
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About 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?"

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Patients must be 18 years of age or older. 2. Patients with histologically confirmed, unresectable stage III or IV malignant melanoma. 3. Patients must be capable of providing consent to enrolment and treatment. 4. Patients with a performance status of ECOG 0-224 will be elig…
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