Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (
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?"
| Condition(s) | Immune-related Adverse Event, Diarrhea, Advanced Melanoma, Advanced Rectal Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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?" |
| Who can participate | 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 eligible for enrolment (see appendix16.1). 5. Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | AHS Cancer Control Alberta |
| Locations | Edmonton, Alberta, Canada |
| Start date | 2024-08-20 |
| NCT ID | NCT05663775 |
| Official listing | https://clinicaltrials.gov/study/NCT05663775 |