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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free-survival | at 6 months | |
| Progression free-survival | at 1 year | |
| Progression free-survival |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with advanced solid cancer treated with anti-PD(L)1 immunotherapy with or without anti-CTLA4 immunotherapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephane Culine, Pr | Contact | 01.42.49.42.47 | stephane.culine@aphp.fr | |
| Matthieu Resche-Rigon | Contact | 0142499742 | 0142499742 | matthieu.resche-rigon@univ-paris-diderot.fr |
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| at 2 years |
| Overall survival | at 6 months |
| Overall survival | at 1 year |
| Overall survival | at 2 years |
| Specific disease survival | at 6 months |
| Specific disease survival | at 1 year |
| Specific disease survival | at 2 years |
| Incidence of adverse events | Adverse events will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | at 2 years |
| Soluble HLA-G levels counts | 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 |