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 Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
20
Mesalamine, also known as 5-aminosalicylic acid (5-ASA)
Cross Cancer Institute
Edmonton, Alberta, Canada
RECRUITINGIncidence of Treatment Related Diarrhea
Diarrhea will be graded according to parameters described within the CTCAE v5.0.
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)
Severity of Treatment Related Diarrhea
Diarrhea will be graded according to parameters described within the CTCAE v5.0.
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)
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.
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)
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.
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
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.
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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
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.
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
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.
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
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
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)