Immune Checkpoint Inhibitors and Pre-existing Autoimmune... | NCT03140137

Studies
Immune Checkpoint Inhibitors and Pre-existing Autoimmune Diseases

NCT03140137

Sponsor

University Hospital, Brest

Status

Completed

Last Update Posted

Apr 22, 2019Actual

Enrollment

112Actual

Phase

Not provided

Conditions

Autoimmune Diseases
Advanced Cancer

Interventions

Checkpoint inhibitor therapy

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 21, 2017Actual

Primary Completion Date

Jan 4, 2018Actual

Completion Date

Jan 4, 2018Actual

First Submitted Date

Feb 24, 2017

First Submission Date that Met QC Criteria

May 2, 2017

First Posted Date

May 4, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2019

Last Update Posted Date

Apr 22, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The tolerance of immune checkpoint inhibitors is unknown in patients with pre-existing autoimmune conditions. This retrospective nation-wide study will assess their tolerance in patients with pre-existing autoimmune conditions who received immune checkpoint inhibitors for an advanced cancer in clinical practice.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

112Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Checkpoint inhibitor therapy	Drug	Treatment by ipilimumab, nivolumab or pembrolizumab for advanced cancer in clinical practice

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Autoimmune disease flare	Increase in the activity of the pre-existing autoimmune disease as assessed by the treating physician	through study completion, an average of 1 year

Secondary Outcomes

Measure	Description	Time Frame
Other immune/inflammatory complications	Development of a new immune/inflammatory condition after the start of the therapy	through study completion, an average of 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pre-existing autoimmune disease as diagnosed by the physician
Immune checkpoint inhibitor therapy for an advanced cancer

Exclusion Criteria:

Auto-immune disease developed only after the start of the immune checkpoint inhibitor therapy
Absence of follow-up

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with a pre-existing autoimmune disease who received immune checkpoint inhibitors for the treatment of an advanced cancer in clinical practice.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Divi CORNEC	CHRU de Brest	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CH d'AIX		Aix-en-Provence		13616	France
CHU de DIJON