Checkpoint Inhibitor Associated Diabetes Mellitus: Early Recognition and Treatment (CERT) Project: A Pilot Study
Sponsored by M.D. Anderson Cancer Center
About this study
To find out if taking a drug called infliximab (the "study drug") is safe and effective in reversing insulin dependence in CIADM.
Primary Objective 1\. To estimate the efficacy of infliximab in reversing insulin dependence in CIADM. Secondary Objective 1. To evaluate the safety of infliximab when used for CIADM. 2. To estimate the duration of time off insulin for patients who are able to discontinue insulin.
Where this study is enrolling
- I'm interested
MD Anderson Cancer Center
Houston, Texas
Who can participate
Exclusion criteria
- ✕Participants already on insulin for pre-existing type 1 or type 2 diabetes.
- ✕Participants with undetectable c-peptide levels i.e. \<0.2 with blood glucose of 145 mg/dl or higher.
- ✕For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- ✕Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- ✕Participants with a h/o active TB or latent TB will be excluded.
- ✕Participants with known history of any NYHA class heart failure or ejection fraction \<50% will be excluded.
- ✕Participants requiring supraphysiological doses of steroids i.e. prednisone \>10mg of equivalent at the time of study entry, will be excluded
- ✕Participants who have ICI hepatitis and myocarditis will be excluded
- ✕Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities ≥ Grade 2) with the exception of alopecia.
- ✕Participants who are receiving any other investigational agents for CIADM.
- ✕History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to Infliximab or other agents used in study.
- ✕Required: any concomitant drugs used as defined in section 5.7 will be excluded.
- ✕Participants with uncontrolled intercurrent illness: active infection/ sepsis
- ✕Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- ✕Participants with psychiatric illness/social situations that would limit compliance with study requirements.
- ✕Pregnant and breastfeeding women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with infliximab. Breastfeeding should be discontinued if the mother is treated with infliximab. These potential risks may also apply to other agents used in this study
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.