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

March 6, 2020 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

281

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective tumor response rate
Time Frame: at 6 months
The impact of HLA-G tumor expression (evaluated by immunohistochemistry) on tumor response rates (evaluated with iRECIST) in solid cancer patients treated with anti-PD(L)1 immunotherapy with or without anti-CTLA4 immunotherapy.
at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: at 2 years
at 2 years
Overall survival
Time Frame: at 1 year
at 1 year
Progression free-survival
Time Frame: at 2 years
at 2 years
Overall survival
Time Frame: at 6 months
at 6 months
Progression free-survival
Time Frame: at 6 months
at 6 months
Progression free-survival
Time Frame: at 1 year
at 1 year
Specific disease survival
Time Frame: at 6 months
at 6 months
Specific disease survival
Time Frame: at 1 year
at 1 year
Specific disease survival
Time Frame: at 2 years
at 2 years
Incidence of adverse events
Time Frame: at 2 years
Adverse events will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0
at 2 years
Soluble HLA-G levels counts
Time Frame: Up to 24 months
Soluble HLA-G levels will be evaluated by ELISA.The correlation between tumor HLA-G expression and soluble HLA-G levels will be studied.
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 10, 2020

Primary Completion (Anticipated)

September 10, 2020

Study Completion (Anticipated)

September 10, 2025

Study Registration Dates

First Submitted

March 4, 2020

First Submitted That Met QC Criteria

March 6, 2020

First Posted (Actual)

March 9, 2020

Study Record Updates

Last Update Posted (Actual)

March 9, 2020

Last Update Submitted That Met QC Criteria

March 6, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • APHP190362

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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