Checkpoint Inhibitors in Patients With Cancer and Underlying Autoimmune Disease

NCT04805099 | Completed

• 1 other identifier: AutoImmune2021
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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).

Conditions

Autoimmune Diseases; Checkpoint Inhibitor; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  Through the completion of the study, for an average of 6 months

Interventions

Checkpoint inhibitor DRUG

Treatment with checkpoint inhibitors in patients with preexisting autoimmune disease

Eligibility Criteria

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

Study Population

Patients with diverse tumor types (early-stage or metastatic) who had received checkpoint inhibitors at HeCOG-affiliated Departments of Oncology Eligible patients had a history of AID, and had received treatment with checkpoint inhibitors as any of line of treatment

You may qualify if:

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

You may not qualify if:

• diagnosis of the autoimmune disease after initiation of immunotherapy

Sponsors & Collaborators

• Hellenic Cooperative Oncology Group: lead

Study Sites (1)

Hellenic Oncology Cooperative Group

Athens, Greece

Location

Related Publications (1)

• Fountzilas E, Lampaki S, Koliou GA, Koumarianou A, Levva S, Vagionas A, Christopoulou A, Laloysis A, Psyrri A, Binas I, Mountzios G, Kentepozidis N, Kotsakis A, Saloustros E, Boutis A, Nikolaidi A, Fountzilas G, Georgoulias V, Chrysanthidis M, Kotteas E, Vo H, Tsiatas M, Res E, Linardou H, Daoussis D, Bompolaki I, Andreadou A, Papaxoinis G, Spyratos D, Gogas H, Syrigos KN, Bafaloukos D. Real-world safety and efficacy data of immunotherapy in patients with cancer and autoimmune disease: the experience of the Hellenic Cooperative Oncology Group. Cancer Immunol Immunother. 2022 Feb;71(2):327-337. doi: 10.1007/s00262-021-02985-6. Epub 2021 Jun 23.

  PMID: 34164709 DERIVED

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 18, 2021
• Study Start: November 1, 2020
• Primary Completion: January 30, 2021
• Study Completion: February 28, 2021
• Last Updated: March 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)