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Clinical Trials/NCT04805099
NCT04805099CompletedNot Applicable

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

Hellenic Cooperative Oncology Group1 site in 1 country126 target enrollmentStarted: November 1, 2020Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
126
Locations
1
Primary Endpoint
progression-free survival

Study Overview

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).

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

progression-free survival

Time Frame: Through the completion of the study, for an average of 6 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Hellenic Cooperative Oncology Group
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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