Checkpoint Inhibitor Associated Diabetes Mellitus: Early Recognition and Treatment (CERT) Project: A Pilot Study

NCT07257068 | Not Yet Recruiting

• 2 other identifiers: 2025-1541NCI-2025-08623
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

To find out if taking a drug called infliximab (the "study drug") is safe and effective in reversing insulin dependence in CIADM.

Conditions

Checkpoint Inhibitor; Pilot Study; Diabetes Melletus

Outcome Measures

Primary Outcomes (1)

• 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

  Through study completion; an average of 1 year.

Study Arms (1)

Pilot Study Treatment wiith Infliximab

EXPERIMENTAL

Other: Infliximab

Interventions

Infliximab OTHER

Given by IV

Pilot Study Treatment wiith Infliximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

Infliximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Priyanka C Iyer, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Priyanka C Iyer, MD

CONTACT

832) 291-6069; piyer@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 2, 2025
• Study Start: April 14, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

US (1)