Checkpoint InhibitorNCT07257068
Checkpoint Inhibitor Associated Diabetes Mellitus: Early Recognition and Treatment (CERT) Project: A Pilot Study
A study testing Infliximab in people with Checkpoint Inhibitor and Pilot Study, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To find out if taking a drug called infliximab (the "study drug") is safe and effective in reversing insulin dependence in CIADM. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Checkpoint Inhibitor, Pilot Study, Diabetes Melletus
- What is being tested?
- Infliximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2026to 31 Dec 2029
- Phase
- Interventional
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
None listed.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
MD Anderson Cancer Center
Houston, Texas, 77030
Priyanka C Iyer, MD, 832-291-6069, piyer@mdanderson.org
Priyanka C Iyer, MD
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.
Read the detailed description
Primary Objective
- To estimate the efficacy of infliximab in reversing insulin dependence in CIADM.
Secondary Objective
- To evaluate the safety of infliximab when used for CIADM.
- To estimate the duration of time off insulin for patients who are able to discontinue insulin.
- Conditions
- Checkpoint Inhibitor, Pilot Study, Diabetes Melletus
- Being tested
- Infliximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabOther
Given by IV
| Study group | Role | What they receive |
|---|---|---|
| Pilot Study Treatment wiith Infliximab | Experimental | Not described Receives: Other: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events (AEs).
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start31 Dec 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Checkpoint InhibitorStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Priyanka C Iyer, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257068
- Sponsor's protocol ID
- 2025-1541
- Other IDs
- NCI-2025-08623
- Status last verified
- Oct 2026
- First submitted
- 18 Nov 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No