Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies
Recruiting now
Conditions studied: Gynecological Malignancies, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Vulvar Cancer
In brief
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).
Key facts
- Study ID
- NCT05914974
- Run by
- University Hospital Tuebingen
- People needed
- 120
- Starts
- 2023-09-11
- Expected to finish
- 2035-04-01
- Last updated by the study team
- 2026-02-10
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Department of Women's Health — Tübingen, Germany (enrolling)
Full record on ClinicalTrials.gov
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