Gynecological Cancer, Immunotherapy
Conditions
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.
Interventions
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.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactGiovanni Scambia, PhD
Outcome results
None listed