Detection of Circulating Therapeutic Monoclonal Antibodies in Biological Samples of Gynecological Cancer Patients.

NCT ID: NCT06797479

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2030-12-01

Brief Summary

Quantification of anti PD-1 mAbs in cancer patients is extremely important to monitor pharmacokinetics and effectiveness of immunotherapy. To detect the ICI mAbs in patients' blood plasma samples, we select three anti PD-1 mAbs (cemiplimab, dostarlimab and pembrolizumab) as prognostic biomarkers which will be quantified using different biochemical/analytical assays.

Conditions

Gynecological Cancer; Immunotherapy

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Interventions

Blood samples for the analysis of sildenafil in plasma

To detect the ICI mAbs in patients' blood plasma samples, we select three anti PD-1 mAbs (cemiplimab, dostarlimab and pembrolizumab) as prognostic biomarkers which will be quantified using different biochemical/analytical assays.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with a confirmed diagnosis of gynecological malignancy;
• Patients currently undergoing or scheduled to undergo immunotherapy as part of their treatment regimen;
• Age > 18 years;
• Patients who are able and willing to provide written informed consent to participate in the study.
• Availability of biological samples.

Exclusion Criteria

• Patients receiving concurrent treatment with other investigational drugs or therapies that may interfere with immunotherapy.
• Presence of significant comorbidities or other medical conditions that, in the opinion of the investigator, would interfere with study participation or interpretation of results (e.g., severe autoimmune diseases, uncontrolled infections);
• Pregnant or breastfeeding women;
• Patients who have received prior monoclonal antibody therapy that could affect the study results;
• Patients who are unable or unwilling to comply with the study procedures and follow-up requirements;
• Brain metastases;
• History of other malignancies within the last 5 years, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

SCAMBIA GIOVANNI

Professore

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giovanni Scambia

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Central Contacts

Giovanni Scambia, PhD

Role: CONTACT

giovanni.scambia@policlinicogemelli.it

+390630155701

Other Identifiers

ID 7345

Identifier Type: -

Identifier Source: org_study_id