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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Immunotherapy; Gynecological Cancer

Treatments: Procedure: Blood samples for the analysis of sildenafil in plasma

Study type: Observational

Funder types: Other

Identifiers

NCT06797479

ID 7345

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.