Evaluation of Clinical and Molecular Biomarkers in Immunotherapy Treatment in Gynecologic Cancer (Immuno-Gyn)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Endometrial Cancer; Cervical Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06737640

6881

Details and patient eligibility

About

Background: Immunotherapy has changed the therapeutic approach for gynecologic gynecological malignancies such us endometrial and cervical cancer. Despite literature data support the strong effect of immunotherapy in these cancers, a share of patients do not respond to immunotherapy. Furthermore the extremely variable immune-related spectrum of toxicity in terms of events and timing makes it necessary to identify predictive factors for the development of these side effects.

Hyphotesis: To evaluate the presence of biochemical, bioumoral and or molecular predictive factors in patients affected by endometrial and cervical cancer treated with immunotherapy plus chemotherapy, immunotherapy plus tyrosine kinase inhibitors (TKI) or immunotherapy alone.

Methodology: We will retrospectively collect data about patients affected by advanced, recurrent or metastatic endometrial cancer (EC) and recurrent cervical cancer (CC) treated with immunotherapy.

We will investigate whether there is a statistically significant difference in the efficacy of immunotherapy according to biochemical, biohumoral and or molecular factors and survival outcomes. Moreover, we will evaluate whether there is a correlation between biochemical, biohumoral and or molecular factors and immune-related adverse events (irAE).

Enrollment: 90 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females aged ≥ 18 years at the time of inclusion in the study.
• Patients diagnosed with advanced, metastatic or recurrent endometrial and cervical cancer treated at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
• Patients with histological confirmation of endometrial and cervical cancer, according to the histotypes suitable for immunotherapy.
• Patients previously treated under Nominal Use and/or Expanded Access Program (EAP) programs can be enrolled in the study.
• Patients who have received at least 1 dose of immunotherapy after starting treatment.
• Signature of the informed consent or declaration in lieu of the consent form where applicable

Exclusion criteria

• Use of immunotherapy within an experimental protocol.
• Patients who continued therapy at another center.