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Checkpoint Inhibitors in Patients With Cancer and Underlying Autoimmune Disease

Real-world Safety and Efficacy Data of Checkpoint Inhibitors in Patients With Cancer and Underlying Autoimmune Disease: the Experience of the Hellenic Cooperative Oncology Group

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04805099
Acronym
CIAD
Enrollment
126
Registered
2021-03-18
Start date
2020-11-01
Completion date
2021-02-28
Last updated
2021-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Diseases, Checkpoint Inhibitor, Immunotherapy

Brief summary

Patients with cancer and concurrent autoimmune diseases (AID) have been universally excluded from clinical trials evaluating immunotherapy. Data on the safety and efficacy of checkpoint inhibitors in patients with underlying AID is limited. The investigators performed a retrospective multicenter review of medical records of patients with diverse tumor types and underlying AID who received checkpoint inhibitors at Departments of Oncology, affiliated with the Hellenic Cooperative Oncology Group (HeCOG). The primary endpoint was progression-free survival (PFS).

Interventions

Treatment with checkpoint inhibitors in patients with preexisting autoimmune disease

Sponsors

Hellenic Cooperative Oncology Group
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18 years or older * Patients with cancer * Patients with autoimmune disease * Treated at HeCOG-affiliated Departments of Oncology * Early-stage or metastatic

Exclusion criteria

* diagnosis of the autoimmune disease after initiation of immunotherapy

Design outcomes

Primary

MeasureTime frame
progression-free survivalThrough the completion of the study, for an average of 6 months

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026