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NCT04805099 Clinical Trial

Checkpoint Inhibitors in Patients With Cancer and Underlying Autoimmune Disease

Autoimmune Diseases Clinical Trial

— CIAD  

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04805099
Other study ID # AutoImmune2021
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2020
Est. completion date February 28, 2021

Study information
Verified date March 2021
Source Hellenic Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 126
Est. completion date February 28, 2021
Est. primary completion date January 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Checkpoint inhibitor
Treatment with checkpoint inhibitors in patients with preexisting autoimmune disease

Locations
Country Name City State
Greece Hellenic Oncology Cooperative Group Athens

Sponsors (1)
Lead Sponsor Collaborator
Hellenic Cooperative Oncology Group

Country where clinical trial is conducted

Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary progression-free survival Through the completion of the study, for an average of 6 months
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