RecruitingNCT05914974
Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies
ICK-Gyn: Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies
Sponsor
University Hospital Tuebingen
Enrollment
120 participants
Start Date
Sep 11, 2023
Study Type
OBSERVATIONAL
Conditions
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: FEMALEMin Age: 18 Years
Inclusion Criteria6
- 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 Criteria5
- 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)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05914974
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