Checkpoint Inhibitors in Patients With Cancer and Underlying Autoimmune Disease

NCT ID: NCT04805099

Last Updated: 2021-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2021-02-28

Brief Summary

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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).

Detailed Description

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Conditions

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Autoimmune Diseases Checkpoint Inhibitor Immunotherapy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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Checkpoint inhibitor

Treatment with checkpoint inhibitors in patients with preexisting autoimmune disease

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hellenic Cooperative Oncology Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hellenic Oncology Cooperative Group

Athens, , Greece

Site Status

Countries

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Greece

References

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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.

Reference Type DERIVED
PMID: 34164709 (View on PubMed)

Other Identifiers

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AutoImmune2021

Identifier Type: -

Identifier Source: org_study_id

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