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

NCT06797479 | Not Yet Recruiting DMC

• 1 other identifier: ID 7345
• Study Type: observational
• Target: 12
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Quantification of anti PD-1.

  Quantification of anti PD-1 mAbs in cancer patients is extremely important to monitor pharmacokinetics and effectiveness of immunotherapy.

  From enrollment to the end of treatment at 4 weeks

Interventions

Blood samples for the analysis of sildenafil in plasma PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with gynecological cancers undergoing immunotherapy

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Giovanni Scambia

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Scambia, PhD

CONTACT

+390630155701; giovanni.scambia@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professore

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: January 28, 2025

Record last verified: 2025-01