Immune-related Adverse EventPhase 2IMPACT 1NCT05663775
Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)
A Phase 2 study testing Mesalamine in people with Immune-related Adverse Event and Diarrhea, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial 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?" Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune-related Adverse Event, Diarrhea, Advanced Melanoma
- What is being tested?
- Mesalamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 20 Aug 2024to Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- 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. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level > 40 mIU/mL to confirm menopause.
- Patients of childbearing / reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period and for a period of 30 days after the last dose of study drug. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.
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- -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
- Absence of any condition hampering compliance with the study protocol and follow- up schedule; those conditions should be discussed with the patient before registration in the trial.
- The following adequate organ function laboratory values must be met:
- Hematological:
- Absolute neutrophil count (ANC) >1.5 x109/L
- Platelet count >100 x109/L
- Hemoglobin >9 g/dL (may have been transfused)
- Renal:
- o Estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)
- Hepatic:
- Total serum bilirubin <2x ULN
- AST and ALT <2.5x ULN (or ≤ 5 x ULN for subjects with documented metastatic disease to the liver)
Who cannot join
- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
- Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
- Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (CTCAE v5 Grade ≥ 3).
- Other severe acute or chronic medical conditions or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G1Z2
John Walker, MD, 780-432-8340
About this study
Official title: Prophylactic Oral Mesalamine for the Prevention of Immune-Related Colitis in Patients Treated 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?"
- Being tested
- Mesalamine
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MesalamineDrug
Also called Salofalk
Mesalamine, also known as 5-aminosalicylic acid (5-ASA)
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic Mesalamine in combination of Immunotherapy (Nivolumab/Ipilimumab) | Experimental | Participants will receive 500mg of Mesalamine QID (four times a day) in combination with standard of care Immunotherapy Receives: Drug: Mesalamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Related Diarrhea
Diarrhea will be graded according to parameters described within the CTCAE v5.0.
Measured: Diarrhea (incidence) 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)
Severity of Treatment Related Diarrhea
Diarrhea will be graded according to parameters described within the CTCAE v5.0.
Measured: Diarrhea (severity) 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)
Causality of Treatment Related Diarrhea
Diarrhea will be graded according to parameters described within the CTCAE v5.0. The cause for diarrhea (treatment-related or not) will be assessed by the treating physician/investigator.
Measured: Diarrhea (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)
Secondary outcomes (5)
Incidence of all IR-AEs (diarrheal and non-diarrheal, all grades)
Adverse events deemed immune-related will be graded according to parameters described within the CTCAE v5.0. The treating physician/investigator will be responsible for determining whether or not an adverse event is immune-related.
Measured: IR-AEs (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)
Incidence of IR-AEs ≥ grade 2
Adverse events deemed immune-related will be graded according to parameters described within the CTCAE v5.0. The treating physician/investigator will be responsible for determining whether or not an adverse event is immune-related.
Measured: 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)
Times to onset and resolution of IR-AEs
Adverse events deemed immune-related will be graded according to parameters described within the CTCAE v5.0. The treating physician/investigator will be responsible for determining whether or not an adverse event is immune-related. The onset of IR-AEs shall be defined as that point in time when a study participant first described signs or symptoms indicative of an IR-AE. Resolution of an IR-AE shall be defined as that point in time when an IR-AE resolves, or in the case where a particular sign/symptom was present prior to study enrolment, the individual participant's baseline.
Measured: IR-AEs (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)
Requirement for immunosuppressive (steroid and non-steroid) medications to manage IR-AEs
The use of steroidal and non-steroidal immunosuppressive therapies will be analyzed during a participant's time on study. The designation of a particular therapy as "immunosuppressive," including whether or not the therapy may be classified as steroidal or non-steroidal will be performed by the treating physician/investigator. Information regarding specific therapy(s) prescribed, as well as duration of said therapy will be collected.
Measured: Concomitant Medications 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)
Frequency of IR-AEs leading to treatment discontinuation
During collection of data regarding incidence/severity of IR-AEs, information regarding whether or not treatment was held (dose-limiting) or permanently discontinued (treatment-limiting) will be collected. As described above, grading of IR-AEs will be in accordance with CTCAE guidance, and assignment of causality will be the responsibility of the treating physician/investigator
Measured: IR-AEs (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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start20 Aug 2024
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune-related Adverse EventStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663775
- Sponsor's protocol ID
- IIT-0007
- Acronym
- IMPACT 1
- Status last verified
- Nov 2026
- First submitted
- 7 Dec 2022
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Oral Mesalamine for the Prevention of Immune-Related Colitis in Patients Treated With Ipilimumab/Nivolumab
- ClinicalTrials.gov ID
- NCT05663775
- Acronym / sponsor ID
- IMPACT 1 / IIT-0007
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 23 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?"
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prophylactic Mesalamine in combination of Immunotherapy (Nivolumab/Ipilimumab) | Experimental | Drug: MesalamineParticipants will receive 500mg of Mesalamine QID (four times a day) in combination with standard of care Immunotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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).
- 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. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level > 40 mIU/mL to confirm menopause.
Key exclusion criteria (4 listed)
- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
- Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
- Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (CTCAE v5 Grade ≥ 3).
- Other severe acute or chronic medical conditions or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MesalamineAlso: SalofalkMesalamine, also known as 5-aminosalicylic acid (5-ASA) | Drug | Prophylactic Mesalamine in combination of Immunotherapy (Nivolumab/Ipilimumab) |
Primary outcome
Incidence of Treatment Related Diarrhea
Time frame: Diarrhea (incidence) 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)
Diarrhea will be graded according to parameters described within the CTCAE v5.0.
Severity of Treatment Related Diarrhea
Time frame: Diarrhea (severity) 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)
Diarrhea will be graded according to parameters described within the CTCAE v5.0.
Causality of Treatment Related Diarrhea
Time frame: Diarrhea (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)
Diarrhea will be graded according to parameters described within the CTCAE v5.0. The cause for diarrhea (treatment-related or not) will be assessed by the treating physician/investigator.
5 secondary outcomes
Incidence of all IR-AEs (diarrheal and non-diarrheal, all grades)
Time frame: IR-AEs (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)
Incidence of IR-AEs ≥ grade 2
Time frame: 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)
Times to onset and resolution of IR-AEs
Time frame: IR-AEs (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)
Requirement for immunosuppressive (steroid and non-steroid) medications to manage IR-AEs
Time frame: Concomitant Medications 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)
Frequency of IR-AEs leading to treatment discontinuation
Time frame: IR-AEs (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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mesalamine in people with Immune-related Adverse Event and Diarrhea, run by AHS Cancer Control Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment Related Diarrhea (time frame: Diarrhea (incidence) 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.