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Mesalamine for Colitis Prevention During Cancer Treatment (IMPACT 1 Trial)
Phase 2
Waitlist Available
Research Sponsored by AHS Cancer Control Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ir-aes that are greater than grade 2 (incidence and severity, as well as causality) will be assessed at each screening, cycle 1-4 (each cycle is 3 weeks) and throughout the post treatment follow-up (12, 18 and 24 weeks)
Awards & highlights
IMPACT 1 Trial Summary
This trial tests if a medicine can lower the chance and seriousness of diarrhea caused by cancer treatment.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
While specific side effects for this study aren't listed, mesalamine generally may cause stomach pain, headache, nausea, vomiting, fever; ipi/nivo might cause immune-related issues like rash or colitis.
IMPACT 1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ ir-aes that are greater than grade 2 (incidence and severity, as well as causality) will be assessed at each screening, cycle 1-4 (each cycle is 3 weeks) and throughout the post treatment follow-up (12, 18 and 24 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~ir-aes that are greater than grade 2 (incidence and severity, as well as causality) will be assessed at each screening, cycle 1-4 (each cycle is 3 weeks) and throughout the post treatment follow-up (12, 18 and 24 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Causality of Treatment Related Diarrhea
Incidence of Treatment Related Diarrhea
Severity of Treatment Related Diarrhea
Secondary outcome measures
Frequency of IR-AEs leading to treatment discontinuation
Incidence of IR-AEs ≥ grade 2
Incidence of all IR-AEs (diarrheal and non-diarrheal, all grades)
+2 moreSide effects data
From 2019 Phase 3 trial • 61 Patients • NCT0141237210%
light headed/dizziness
6%
Increased bowel movement
6%
Abdominal Pain
6%
Sinusitis
3%
Upper respiratory infection
3%
Fatigue
3%
Nausea
3%
Reflux
3%
Sharp pain
3%
Motion Sickness
3%
Bloating
3%
Swelling
3%
Weight Gain
3%
Fever
3%
Hematochezia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mesalamine
Placebo
IMPACT 1 Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mesalamine
2016
Completed Phase 4
~2010
Find a Location
Who is running the clinical trial?
AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
36,192 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on immunosuppressive medication, except for allowed cases.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.I am not breastfeeding or will stop before starting the treatment.I have a serious heart condition.I don't have any severe health issues that could make the study risky for me.I agree not to donate sperm during and for 30 days after the study.I am of childbearing age and have a negative pregnancy test.I am able to understand and agree to the treatment plan.I am able to get out of my bed or chair and move around.
Research Study Groups:
This trial has the following groups:- Group 1: Prophylactic Mesalamine in combination of Immunotherapy (Nivolumab/Ipilimumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What can be said about the security of administering Mesalamine in tandem with Immunotherapy (Nivolumab/Ipilimumab) for patients?
"Considering the lack of evidence for efficacy, our team at Power assigned Prophylactic Mesalamine in combination with Immunotherapy (Nivolumab/Ipilimumab) a score of 2 on the safety scale."
Answered by AI
Are there still opportunities to enroll in this research project?
"Per the details on clinicaltrials.gov, this medical trial is no longer seeking participants; it was first published April 1st 2023 and last updated December 15th 2022. However, there are 314 other trials that are currently enrolling patients."
Answered by AI
What results does this investigation seek to accomplish?
"The primary outcome of this trial, evaluated over the Diarrhea (incidence) period and at Screening, Cycle 1-4 (each cycle is 3 weeks), as well as during post-treatment follow-up (12, 18 and 24 weeks), will be an appraisal of Treatment Related Diarrhea Severity. Secondary outcomes encompass Incidence of IR-AEs ≥ grade 2 - adverse events determined to have an immune link are classified according to CTCAE v5.0 criteria by treating physician/investigator; Times to onset and resolution of IR-AEs – once signs or symptoms demonstrating a potential IR-AE manifest"
Answered by AI
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