A Prospective Study of the Relevance of the HLA-G Immune Checkpoint in Cancer Immunotherapy
GEIA
1 other identifier
observational
281
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2020
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2020
CompletedFirst Posted
Study publicly available on registry
March 9, 2020
CompletedStudy Start
First participant enrolled
March 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2025
CompletedMarch 9, 2020
March 1, 2020
6 months
March 4, 2020
March 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Objective tumor response rate
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 Outcomes (11)
Progression free-survival
at 6 months
Progression free-survival
at 1 year
Progression free-survival
at 2 years
Overall survival
at 6 months
Overall survival
at 1 year
- +6 more secondary outcomes
Study Arms (1)
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.
Eligibility Criteria
Adult patients with advanced solid cancer treated with anti-PD(L)1 immunotherapy with or without anti-CTLA4 immunotherapy.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2020
First Posted
March 9, 2020
Study Start
March 10, 2020
Primary Completion
September 10, 2020
Study Completion
September 10, 2025
Last Updated
March 9, 2020
Record last verified: 2020-03