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

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Solid Tumor

Study type: Observational

Funder types: Other

Identifiers

NCT04300088

APHP190362

Details and patient eligibility

About

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.

Enrollment: 281 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

281 participants in 1 patient group

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

Description:

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