Clinical trial · Observational
Detection of Circulating Therapeutic Monoclonal Antibodies in Biological Samples of Gynecological Cancer Patients.
NCT06797479CI-TRIAL-00085172IMMUNO_ASSAYnot yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecological Cancer | — | UNRESOLVED | — |
| Immunotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood samples for the analysis of sildenafil in plasma | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Quantification of anti PD-1.
- timeFrame
- From enrollment to the end of treatment at 4 weeks
- description
- Quantification of anti PD-1 mAbs in cancer patients is extremely important to monitor pharmacokinetics and effectiveness of immunotherapy.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.