A Prospective Study of the Relevance of the HLA-G Immune Checkpoint in Cancer Immunotherapy

NCT ID: NCT04300088

Last Updated: 2020-03-09

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

UNKNOWN

Total Enrollment

281 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-10

Study Completion Date

2025-09-10

Brief Summary

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Therapeutic targeting of immune checkpoints PD-1/PD-L1 and/or CTLA-4 is efficient in several solid cancer subtypes, however only some patients do experience clinical benefit from these treatments. One explanation could be that multiple redundant checkpoints are present within the tumor, simultaneously keeping in check the patient's immune response. The immune checkpoint HLA-G is neo-expressed in over 50% of cases in some cancer subtypes and associated with more dismal prognosis. The immunosuppressive effects of HLA-G may result in resistance to current immunotherapy drugs.

The GEIA study explores the impact of HLA-G tumor expression on the efficacy of cancer immunotherapy in solid cancer patients.

Detailed Description

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Conditions

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Solid Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with advanced solid cancer treated with anti-PD(L)1

Adult patients with advanced solid cancer treated with anti-PD(L)1 immunotherapy with or without anti-CTLA4 immunotherapy.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age 18 or older
* Social insurance
* Ability to provide signed consent
* Histologically proven solid cancer (non-small cell lung cancer, urothelial carcinoma, renal cell carcinoma, other)
* Advanced and/or metastatic disease not accessible to local treatment
* At least one target lesion according to iRECIST
* Available fixed tumor sample for immunohistochemistry studies
* Treatment with anti-PD(L)1 immunotherapy with or without anti-CTLA4 immunotherapy

Exclusion Criteria

* Women pregnant or breastfeeding
* Inability to consent to this research
* Previous cancer immunotherapy (except BCG instillations for non-muscle infiltrative bladder cancer)
* Patients chronically infected with HIV, HBV or HCV
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Stephane Culine, Pr

Role: CONTACT

01.42.49.42.47

Matthieu Resche-Rigon

Role: CONTACT

0142499742 ext. 0142499742

Other Identifiers

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APHP190362

Identifier Type: -

Identifier Source: org_study_id

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