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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial population

Patients with gynecological cancers undergoing immunotherapy

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

  • Blood samples for the analysis of sildenafil in plasma

    Procedure/Surgery

    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.

Treatment groups

No treatment groups listed

Trial outcomes

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.

Time frame
From enrollment to the end of treatment at 4 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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