Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAHS Cancer Control Alberta
About this trial
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?"
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Mesalamine
DrugMesalamine, also known as 5-aminosalicylic acid (5-ASA)
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Prophylactic Mesalamine in combination of Immunotherapy (Nivolumab/Ipilimumab)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence 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)2
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)3
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)Secondary outcomes
1
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)2
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.
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)3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov