Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Mesalamine for Immune-related Adverse Event

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?"

Official registry: https://clinicaltrials.gov/study/NCT05663775 · AHS Cancer Control Alberta · enrollment listed as 20

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Mesalamine. The registry lists allocation as na. 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?"

They plan to enroll about 20 people at Edmonton. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Mesalamine

Primary outcome (registry wording): Incidence of Treatment Related Diarrhea

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Patients must be 18 years of age or older
  • Patients with histologically confirmed, unresectable stage III or IV malignant melanoma
  • Patients must be capable of providing consent to enrolment and treatment
  • Patients with a performance status of ECOG 0-224 will be eligible for enrolment (see appendix16.1)
  • Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard
  • Female patients who are breast-feeding should discontinue nursing prior to the first dose of study treatment and until 30 days after the last dose of study drug
  • Male patients should agree to not donate sperm during the study and for a period of at least 30 days after last dose of study drug

Contact

No central phone on the registry card. Use the official listing to reach a site.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT05663775 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05663775?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05663775?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary