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Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies

RECRUITINGSponsored by University Hospital Tuebingen
Actively Recruiting
SponsorUniversity Hospital Tuebingen
Started2023-09-11
Est. completion2027-04
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05914974

Summary

ICK-Gyn is a prospective, multicentric, non-interventional investigator-initiated trial (IIT) that aims to investigate the prognostic value of CRP kinetics in advanced or metastatic gynecological malignancies under immune checkpoint inhibitor (ICI) therapy on the objective response rate (ORR), progression-free survival (PFS) and overall survival (OS).

Eligibility

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
Inclusion Criteria:

* women ≥ 18 years of age
* histologically proven metastatic gynecological malignancies irrespective of therapy line
* patients with advanced or metastatic gynecological malignancies must fulfill treatment requirements for ICI therapy in the experimental group
* planned ICI therapy in combination with palliative chemotherapy in the experimental group
* patients with advanced or metastatic gynecological malignancies that undergo chemotherapy without ICIs in the first therapy line in the control group
* written informed consent into ICK-Gyn

Exclusion Criteria:

* missing indication for ICI therapy in the experimental group
* any ICI therapy before inclusion into the trial
* patients with advanced or metastatic endometrial or cervical cancer in the second or higher therapy line without indication to ICI therapy
* pregnant or lactating patients
* inadequate general condition (not fit for chemotherapy)

Conditions6

CancerCervical CancerEndometrial CancerGynecological MalignanciesOvarian CancerVulvar Cancer

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