Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies
Recruiting
Observational Study
Gynecological MalignanciesCervical CancerEndometrial CancerOvarian CancerVulvar Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Female
Study type
Observational
Participants needed
120 (estimated)
Sponsor
University Hospital Tuebingen · Other
Who this trial is looking for
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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).
Trial Locations
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Status
Eligibility Criteria
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 ther…
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)
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