Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)
NCT05663775 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-06-27
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?"
Conditions
- Immune-related Adverse Event
- Diarrhea
- Advanced Melanoma
- Advanced Rectal Carcinoma
Interventions
- DRUG
-
Mesalamine
Mesalamine, also known as 5-aminosalicylic acid (5-ASA)
Sponsors & Collaborators
-
AHS Cancer Control Alberta
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-20
- Primary Completion
- 2026-08-31
- Completion
- 2027-08-31
Countries
- Canada
Study Locations
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