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Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies

Recruitingn/aAges 18 Years - anyFemaleUniversity Hospital Tuebingen
NCT05914974 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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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What it tests

  • Not listed
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Where

1 site
Department of Women's Health
Tübingen, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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