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Mesalamine

Phase 2

Immune-related Adverse Event | Small molecule | Oncology |Avalon GloboCare Corp.|Last Updated: Jun 27, 2025

Target and mechanism

Molecular targetALOX5, PTGS2, PTGS1, PPARG
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL704

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

Mesalamine · 1 trial · 4 indications

Phase 2 1
NCT05663775Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)Immune-related Adverse Event
RECRUITING20 Analytics
PHASE2RECRUITING
Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)
Immune-related Adverse Event
NCT0566377520
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Study Endpoints

Primary Endpoints

Incidence of Treatment Related Diarrhea
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
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
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.

Secondary Endpoints

Incidence of all IR-AEs (diarrheal and non-diarrheal, all grades)
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
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
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)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Prophylactic Mesalamine in combination of Immunotherapy (Nivolumab/Ipilimumab)EXPERIMENTALParticipants will receive 500mg of Mesalamine QID (four times a day) in combination with standard of care Immunotherapy

Interventions

NameTypeDescription
MesalamineDRUGMesalamine, also known as 5-aminosalicylic acid (5-ASA)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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 elig...

Countries:Canada
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Frequently asked questions about Mesalamine

What is Mesalamine used for in immune-related adverse events?

Mesalamine is being studied as a prophylactic treatment to prevent colitis in patients receiving ipilimumab and nivolumab (Ipi/Nivo) combination therapy. The Phase 2 trial targets immune-related adverse events, specifically diarrhea and colitis, in patients with advanced melanoma or advanced rectal carcinoma.

What does Mesalamine target?

Mesalamine is a small molecule that acts locally in the gastrointestinal tract to reduce inflammation. It is being evaluated for its ability to prevent colitis, an immune-related adverse event, when given prophylactically alongside ipilimumab and nivolumab immunotherapy.

Who is developing Mesalamine for this indication?

Avalon GloboCare Corp. (NASDAQ: ALBT) is developing Mesalamine for the prevention of immune-related colitis. The company is conducting a Phase 2 clinical trial to assess its efficacy in patients receiving ipilimumab and nivolumab for advanced melanoma or advanced rectal carcinoma.

What phase is Mesalamine in for immune-related adverse events?

Mesalamine is in Phase 2 clinical development for the prevention of colitis associated with ipilimumab and nivolumab therapy. The trial is currently recruiting participants and is designed as an uncontrolled, open-label study with a target enrollment of 20 patients in Canada.

What clinical trials is Mesalamine in?

Mesalamine is being evaluated in the clinical trial NCT05663775, titled 'Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)'. This Phase 2 study is recruiting patients aged 18 years and older with advanced melanoma or advanced rectal carcinoma, with an enrollment target of 20 participants.

Is Mesalamine the same as 5-ASA?

Mesalamine is also known as 5-aminosalicylic acid (5-ASA), a well-established anti-inflammatory agent used for gastrointestinal conditions. In the context of this Phase 2 trial, it is being repurposed as a prophylactic measure to prevent immune-related colitis in patients undergoing combination immunotherapy.