Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity Hospital Tuebingen
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
120 Participants
are grouped into 2 trial groupsSponsors and collaborators
University Hospital Tuebingen
Lead sponsor
University Hospital Ulm
Collaborator
University Hospital Freiburg
Collaborator
Source ClinicalTrials.gov