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Clinical Trials in Germany / NCT05914974
Recruiting Observational

Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies

NCT05914974 · tracked via the Priya Life Science Germany tracker
Sponsor
University Hospital Tuebingen
Phase
Observational
Started
2023-09-11
Last updated
2026-02-10

Condition(s) studied

Gynecological MalignanciesCervical CancerEndometrial CancerOvarian CancerVulvar Cancer

Study 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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Prognostic value of CRP kinetics under ICI therapy on progression-free survival (PFS) — duration of therapy and follow-up data (10 years)
    Evaluation of CRP kinetics to predict progression-free survival in advanced or metastatic gynecological malignancies treated with ICIs in combination with chemotherapy. The CRP value is determined from blood samples.

Trial sites (1)

FacilityCityRegionStatus
Department of Women's Health Tübingen Germany Recruiting

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A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021) Recruiting
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Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005) Active, not recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05914974 on ClinicalTrials.gov ↗ ← All trials in Germany