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

Not yet recruiting

• Conditions: Gynecological Cancer; Immunotherapy

• Registration Number: NCT06797479
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-22
• Last Update Submitted: 2025-01-22
• Study First Posted: 2025-01-28
• Last Update Posted: 2025-01-28
• Study Start: 2025-03-01
• Primary Completion: 2030-03-01
• Study Completion: 2030-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 12

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantification of anti PD-1.	From enrollment to the end of treatment at 4 weeks	Quantification of anti PD-1 mAbs in cancer patients is extremely important to monitor pharmacokinetics and effectiveness of immunotherapy.