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NCT Number: NCT06797479

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Quantification of anti PD-1.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanni Scambia, PhD

CONTACT

[email protected]

+390630155701

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: IMMUNO_ASSAY

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jan 28, 2025
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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