Evaluation of Clinical and Molecular Biomarkers in Immunotherapy Treatment in Gynecologic Cancer

Not yet recruiting

• Conditions: Cervical Cancer; Endometrial Cancer

• Registration Number: NCT06737640
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study Start: 2024-12-16
• Study First Submitted QC: 2024-12-16
• Last Update Submitted: 2024-12-16
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 90

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of biomarkers in immunotherapy in endometrial cancer.	12 months	Evaluate the association between biochemical, biohumoral and molecular factors and survival outcome in patients with advanced, metastatic or recurrent endometrial cancer treated with immunotherapy and chemotherapy, immunotherapy and tyrosine kinase inhibitors or immunotherapy in monotherapy.
Evaluation of biomarkers in immunotherapy in cervical cancer.	12 months	Evaluate the association between biochemical, biohumoral and molecular factors and survival outcome in patients with advanced, metastatic or recurrent cervical cancer treated with immunotherapy and chemotherapy, immunotherapy and tyrosine kinase inhibitors or immunotherapy in monotherapy.

Secondary Outcome Measures

Name	Time	Method
Evaluation of immuno-related adverse events (irAEs) in gynecologic cancer.	12 months	Evaluate the association between biochemical, biohumoral and possibly molecular factors and the onset of immune-related adverse events during and after the end of immunotherapy treatment.

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, UOC Ginecologia Oncologica; 🇮🇹 Roma, Lazio, Italy